MINISTRY OF EDUCATION MINISTRY OF DEFENSE

AND TRAINING

108 INSTITUTE OF CLINICAL MEDICAL AND

PHARMACEUTICAL SCIENCES

--------------------------------------------------------

LE VAN LOI

STUDY ON THE VALUE OF MAGNETIC RESONANCE

IMAGING, LAPAROSCOPIC SURGERY AND

CHOLANGIOSCOPIC LITHOTRIPSY THROUGH

CHOLEDOCHO - CUTANEOUS CHANNEL IN THE

TREATMENT OF MAIN BILE DUCT STONES

Specialty: Digestive Surgery

Code: 62720125

SUMMARY OF MEDICAL DOCTORAL DISSERTATATION

Hanoi – 2021

THIS STUDY WAS CONDUCTED AT 108 INSTITUTE OF

CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES

Scientific Supervisors:

1. A/Prof. Dr. Trieu Trieu Duong

2. Dr. Le Nguyen Khoi

Reviewer:

1.

2.

3.

The dissertation will be defended at thesis defense council at:

108 Institute of Clinical Medical and Pharmaceutical Sciences.

At..........day..........month........... 2021

Further reference to the thesis at:

1. Vietnam national library

2. 108 Institute of clinical medical and pharmaceutical

sciences library

1

INTRODUCTION

Gallstone disease is a common disease in Vietnam (3.32 - 6.11%

of the population) as well as in other countries around the world

which is associated with complicated disease progression, numerous

serious complications and even death if not treated promptly,

especially in case of intrahepatic gallstones.

To effectively treat gallstone disease, it is necessary to accurately

determine the location, the number of stones, and abnormal biliary

tract anatomy to choose the appropriate treatment method. Magnetic

resonance imaging is the most chosen method for gallstone

evaluation because of many advantages. However, there have not

been many studies on the imaging characteristics as well as the value

of magnetic resonance imaging in the diagnosis of gallstones in our

country. Therefore, further studies were needed to clarify the issue.

In Vietnam, laparoscopic surgery for gallstone disease started in

1992 at Cho Ray hospital. Along with the development of science

and technology, cholangioscopes as well as different methods of

lithotripsy and stone retrieval have been used. Consequently,

laparoscopic surgery combined with cholangioscopy has been widely

applied in the treatment of cholelithiasis. However, laparoscopic

surgery combined with cholangioscopy is still challenging due to

various causes including: difficult manipulation of the

cholangioscope due to increasing gap between the common bile duct

and the abdominal wall when the abdomen is inflated, difficulty in

maintaining the water pressure to dilate the bile ducts due to

continuous water leak at the site of the bile duct opening, spillage of

stone fragments and bile into the abdominal cavity leading to the

need of continous suctioning, prolonged operative time and potential

2

residual abscess formation. To overcome these above-mentioned

disadvantages, Vo Dai Dung et al had created a choledocho-

cutaneous channel through which cholangioscopic lithotripsy can be

performed.

However, there was still a lack of comprehensive research on this

issue in our country. Therefore, we decided to perform the thesis:

“Study on the value of magnetic resonance pancreato, laparoscopic

surgery and cholangioscopic lithotripsy through choledocho-

cutaneous channel in the treatment of main bile duct stones” with

two objectives:

1. To study the value of magnetic resonance imaging in the

the diagnosis of main bile duct stones.

2. To evaluate the results of laparoscopic surgery and

cholangioscopic lithotripsy through choledocho-cutaneous

channel in the treatment of main bile duct stones.

3

Chapter 1

LITERATURE REVIEW

1.1. The value of magnetic resonance imaging in the diagnosis of

cholelithiasis

1.1.1. In other countries

In developed countries, magnetic resonance cholangiopancreatography

(MRCP) has long been considered the most comprehensive method for

assessing biliary pathologies including cholelithiasis. There have been many

studies on imaging characteristics and values of MRCP in the evaluation of

cholelithiasis.

Many other studies compared other imaging methods including

ultrasound, CT scan, endoscopic ultrasound and endoscopic retrograde

cholangiopancreatography (ERCP) with MRCP. Some authors

concluded that MRCP can replace ERCP in the diagnosis of

choledochal stones.

The results from studies of other countries showed that the values of

MRCP in the diagnosis of cholelethiasis were as followed: sensitivity

91-100%, specificity 90-100%, positive predictive value 82 to 96 %,

and negative predictive value 96 - 100%.

1.1.2. In Vietnam

In Vietnam, there have been many studies on the chemical

composition of gallstones, on the pathogenesis of gallstones, and on the

values of different diagnostic imaging modalities in the diagnosis of

cholelithiasis including plain radiograph, ERCP, T tube cholangiogram,

ultrasound, intraoperative ultrasound.

Studies in Vietnam on the value of MRCP in the diagnosis of cholelithiasis

showed sensitivity of 92.5 - 100%, specificity of 83.3 - 90.9%, positive

predictive value of 96.2 - 98% and negative predictive value of 80 - 100%.

4

1.2. Results of laparoscopic surgery and cholangioscopic

lithotripsy through choledocho-cutaneous channel in the

treatment of main bile duct stones.

1.2.1. In other countries

Main bile duct Gallstones in Western countries are usually

secondary stones migrating from the gallbladder which are usually

small, in small number, often coexist with gallbladder stones, and are

located below the cystic duct without intrahepatic stones. Therefore,

transcystic stone removal is associated with resonable success rate of

50.4- 82.5%. In contrast, in Asian countries such as Hong Kong,

India, transcystic stone removal is not as common compared to

Western countries. There have been an increasing number of studies

on the application of laparoscopic surgery in the treatment of

gallstones with broadening indications However, there was no

research on laparoscopic treatment of main bile duct stones with the

use of cholangioscopic lithotripsy and choledocho-cutaneous

channel.

Overall results of studies using cholangioscopy to treat gallstones

around the world were as followed: success rates of 85 - 99%,

complication rate of 3.4 - 21.4% (most common complications were

infection and postoperative bile leakage). Bile leakage was the main

cause of death after surgery. Residual stone rate was 3.1 - 13%.

1.2.2. In Vietnam

The first cholecystectomy in Vietnam was performed at Cho Ray

Hospital in 1992 followed by a rapid increase in number of studies

on laparoscopic treatment of other diseases. In 1998, also at Cho Ray

Hospital, abdominal wall-lifting laparoscopic exploration of the

common bile duct to treat gallstones was first performed. In 1999,

5

Ho Chi Minh City University of Medicine and Pharmacy Hospital

performed conventional laparoscopic transcystic and

transcholedochal common bile duct exploration. In 2000, Viet Duc

Hospital and Hue Central Hospital started laparoscopic treatment

common bile duct stones.

Overall results of studies on laparoscopic surgery using

cholangioscopy to treat gallstones in Vietnam showed the following

results: success rate 86.49 - 100%, complication rate 3.9-11 21%

with the most common complications being infection, bile leakage

and residual abscess requiring reoperation.

In Vietnam, in order to overcome the above-mentioned limitations

of laparoscopic surgery combined with cholangioscopy, Le Nguyen

Khoi et al had created a choledocho-cutaneous channel through

which gallstones can be removed. However, Vo Dai Dung was the

first author who reported 43 cases of intrahepatic stones with or

without extrahepatic stones treated with laparoscopic surgery and

cholangioscopy through this channel with good results.

Therefore, cholangioscopy and especially the choledocho-

cutaneous channel plays an important role in laparoscopic treatment

of cholelithiasis by reducing the difficulties in controlling the

flexible cholangioscope as well as the rate of stones and bile spillage

into the abdominal cavity, reducing the operative time, increasing the

rate of stone clearance, and reducing abdominal cavity infection as

well as the postoperative residual abscess rates. In Vietnam, the

application of cholangioscopy and choledocho-cutaneous channel

was still limited. This study aimed to clarify the role of laparoscopic

surgery, cholangioscopy through the choledocho-cutaneous channel

in the treatment of cholelithiasis.

6

Chapter 2

SUBJECTS AND METHODS

2.1. SUBJECTS

2.1. Study subjects

Including 84 patients diagnosed with main bile duct stones,

treated with laparoscopic surgery combined with cholangioscopic

lithotripsy through the choledocho-cutaneous channel at Department

of Hepato-Biliary and Pancreatic Surgery of 108 Military Central

Hospital from June 2017 to March 2020

2.1.1. Inclusion criteria:

- Patients with a positive diagnosis of main bile duct stones

(confirmed in surgery), offered magnetic resonance

cholangiopancreatography (MRCP) and common bile duct diameter

of ≥ 8mm (on MRCP).

- Patients received laparoscopic surgery combined with

cholangioscopy through the chodedocho-cutaneous channel (LS-

CCC) as treatment.

- Patients agreed to participate in the study.

2.1.2. Exclusion criteria:

- Contraindications of general anesthesia needed for laparoscopic

surgery.

- Common bile duct diameter < 8mm on MRCP.

- Indications for hepatectomy e.g. biliary stenosis-induced focal

liver atrophy...

- Patients refused to participate in the study.

2.2. STUDY METHODS

2.2.1. Study design: a descriptive, propective study.

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2.2.2. Study parameters

2.2.2.1. General characteristics of patients

* Clinical characteristics

- Age, gender.

- Clinical characteristics: pain, fever, jaundice, Charcot triads.

- History: number of previous ERCP, open common bile duct

(CBD) exploration, CBD exploration and cholecystectomy,

cholecystectomy, other abdominal operations.

- Comorbidities: cardiovascular diseases, pulmonary diseases,

diabetes, cirrhosism, etc…

* Paraclinical characteristics

Blood tests:

- Hematologic: white blood cell counts, neutrophil rate

- Biochemistry: total bilirubin, SGOT, SGPT.

- Coagulation panel: prothrombin ratio.

Hepatobiliary ultrasound:

- Biliary tract: common bile duct, right and left hepatic ducts sizes

- Bile duct stones: position, size, number

MRCP:

- Biliary tract: common bile duct, right and left hepatic ducts

sizes, stricture location.

- Bile duct stones: position, size, number

2.2.2.2. Value of MRCP in the diagnosis of cholelithiasis

- Stone position determined by MRCP

- Stone position determined intraoperatively

- Stone number determined by MRCP : small vs large number

- Stone number determined intraoperatively: small vs large number

8

- Biliary stricture location determined on MRCP and

intraoperatively.

- Determine the value of MRCP in the diagnosis of stone

position, number, biliary strictures by comparing with intraoperative

findings to calculate the Sensitivity, specificity, accuracy, positive

predictive value, negative predictive value using 2 x 2 tables.

2.2.2.3. Results of LS-CCC in the treatment of main bile duct

stones.

* Intraoperative characteristics

- Number of trocarts used: 4 trocarts, 5 trocarts

- Abdominal cavity condition: no adhesion, mild adhesion,

severe adhesion.

- Presence of bilary drainage: yes/no

- Cholecystectomy: yes/no

- Subhepatic drainage: yes/no

- Complications: hemorrhage, injuries of portal vein, hepatic

artery, duodenum, colon, etc…

- Operative time: counted from skin incision of the first trocart to

closure of the last trocart (minutes)

Placement of choledocho-cutaneous channel (CCC):

- Successful placement of CCC: yes/no.

- Placement time (mins)

- Difficulties: biliary injury, CCC dislodgement during stone

removal, stone and bile spillage into the abdominal cavity.

Cholangioscopy through CCC.

- Stone position, stone number (large vs small number).

- Biliary stricture: mild/moderate/severe stricture.

- Sphincter of Oddi: normal/stenosed

9

- Stone removal:

+ Methods: Mirrizi forcep, basket, lithotripsy.

+ Number of stones removed: small vs large number

+ Stone clearance: observed stone cleared vs retained

+ Retained stones: position, causes

- Time of stone removal: from the start to the end of stone

removal (mins).

* Early postoperative results

- Pain duration: based on postoperative analgesic use duration (days).

- Time to return of bowel function: from surgery to first flatus (days).

- Time to subhepatic drain removal: from surgery to drain removal (days).

- Hospital stay: from surgery to discharge (days).

- Early complications: hemorrhage, postoperative fluid collection,

intestinal fistula, biliary fistula, others…

Stone clearance results

- Ultrasound examination:

+ Stone clearance: yes/no

+ Retained stones: position

- Cholangiography:

+ Stone clearance: yes/no

+ Retained stones: position

- Cholangioscopy: yes/no.

Stone clearance was assessed by three modalities:

cholangioscopy, ultrasound, cholangiography. Stone clearance was

defined as no retained stones detected on all three modalities.

Factors associated with stone clearance:

- Stone position.

- Stone number.

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- Biliary strictures. - Surgical history. * Follow-up results - Follow-up: yes/no - Follow-up types: regular/irregular - Time to follow-up: from surgery to follow-up day (days) - Ultrasound + Stone cleared/retained + Retained stoned position - Management of retained stones

+ Removal of biliary drain

+ Trans T-tube CBD exploration: number of procedures, suceess/failure of stone clearance. Results of surgery classification (criteria of the study group) - Good: + Successful placement of CCC + Stone clearance + No complications - Fair: + Successful placement of CCC + Retained stones or complications requiring only conservative therapies - Average: + Failure of placement of CCC + Reoperation due to complications - Bad: postoperative death 2.2.4. Data analysis - All data were encrypted and inputted into a computer and then processed using SPSS 20.0 software - The difference was considered statistically significant when p < 0.05 - Determine the values of MRCP in terms of the diagnosis of location, the number of stones of the CBD, RHD, LHD: sensitivity, specificity, accuracy, positive predictive value, negative predictive value (using 2x2 tables).

11

Chapter 3

RESULTS

3.1. Value of MRCP in the diagnosis of main bile duct stones

- Diagnosis of the position of extrahepatic stones: sensitivity: Se =

97.05%, specificity: Sp = 93.75%, accuracy: Acc = 96.42%, positive

predictive value : PPV = 98.51%, negative predictive value: NPV =

88.23%.

- Diagnosis of the position of right liver bile duct stones:

sensitivity: Se = 95.65%, specificity: Sp = 94.73%, accuracy: Acc =

95.23%, positive predictive value : PPV = 95.65%, negative

predictive value: NPV = 94.73%.

- Diagnosis of the position of left liver bile duct stones: sensitivity:

Se = 96.49%, specificity: Sp = 88.88%, accuracy: Acc = 94.04%,

positive predictive value : PPV = 94.82%, negative predictive value:

NPV = 92.30%

- Diagnosis of the number of main bile duct stones: sensitivity: Se

= 77.77%, specificity: Sp = 98.66%, accuracy: Acc = 96.42%,

positive predictive value: PPV = 87.50%, negative predictive value:

NPV = 97.36%.

- Diagnosis of biliary strictures: sensitivity: Se = 93.75%,

specificity: Sp = 100%, accuracy: Acc = 98.81%, positive predictive

value: PPV = 100%, negative predictive value: NPV = 98.55%

3.2. Results of LS-CCC in the treatment of main bile duct stones.

3.2.1. Intraoperative findings

- In 95.2 % of patients 4 trocarts were used and in only 4.8% of

patients 5 trocarts were used.

- 41.7% of patients with history of abdominal operations having

adhesion, in which 35.7% of patients had severe adhesion.

12

* Placement of CCC:

- Success rate: 100%

- Placement time: 5.05 ± 2.47 mins

- Bile duct injury during placement: 02 patients (2.4%)

- Channel dislodgement during stone removal: 03 patients (3.6%)

- There were no cases with stone or bile spillage into the

abdominal cavity.

* Complications:

01(1.2%) patient with colon seromuscular injury and repaired

laparoscopically.

01(1.2%) patient with biliary hemorrhage after bilary dilatation

using stone, treated with warm saline irrigation.

* Operative time:

Mean: 121.85 ± 30.47 (mins)

* Biliary strictures:

Mild - 1 patient (1.2%), moderate – 4 patients (4.8%), severe 11

patients (13.1%)

* Stone removal results:

Observed stone clearance by cholangioscopy: 69 patients (82.1%)

Observed retained stones by cholangioscopy: 15 patients

(17.9%)

* Causes of retained stones observed by cholangioscopy:

Biliary strictures: 15/15 (100%) patients

* Time of stone removal:

Mean: 52.50 ± 22.84 mins

3.2.2. Early results

- Postoperative pain duration: 1.9 ± 0.53 days (1- 4 days)

- Time to return of bowel function: 2.17 ± 0.82 days (1- 4 days)

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- Postoperative hospital stay: 9.48 ± 3.609 days (4 - 24 days)

- Postoperative complications: 8 patients (9.6%): including

intestinal fistula – 1 patient (1.2%), biliary fistula - 1 patient (1.2%).

Table 3.24. Stone removal results

Stone clearance Patients (n = 84) Rate (%)

Cholangioscopy 69 82.1

Ultrasound 46 54.8

Cholangiography 72 85.7

Total clearance 46 54.8

* Factors related to postoperative stone clearance: stone position,

number, biliary stricture and no association with surgical history

3.2.3. Follow-up results

* Mean time to follow-up: 31.77 ± 11.23 (days)

* Ultrasound results:

Stone clearance: 58 patients (69%)

Stone retained: 26 patients (31%)

* Management after follow-up:

Biliary drain removal during follow-up: 58 patients (69%)

Admission for trans T-tube CBD exploration: 26 patients (31%)

Trans T-tube CBD exploration one time: 22 patients = 26.2 %

Stone retained after treatment: 4 patients = 4.8%

Stone clearance after treatment: 80 patients = 95.2%

3.2.4. Treatment result classification

Good: 50 (59.5%) patients

Fair: 34 (40.5%) patients

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Chapter 4

DISCUSSION

4.1. Values of MRCP in the diagnosis of main bile duct stones

4.1.1. Stone position

* Extrahepatic main bile duct stone position

The diagnosis of extrahepatic main bile duct stone position by

MRCP had the sensitivity (Se) of 97.5%, the specificity (Sp) of

93.75%, the accuracy (ACC) of 96.42%, the positive predictive value

(PPV) of 98.5%, and the negative predictive value (NPV) of 88.23%

(Table 3.13). This result is equivalent to the study of Pham Hong

Lien, Nguyen Viet Thanh.

* Right intrahepatic bile duct stone position

The diagnosis of right intrahepatic bile duct stone position by

MRCP had the sensitivity (Se) of 95.65%, the specificity (Sp) of

94.73%, the accuracy (Acc) of 95.23%, the positive predictive value

(PPV) of 95.65%, the negative predictive value (NPV) of 94.73%

(Table 3.14). Nguyen Huu Thinh, Park et al. studied the value of

MRCP in the diagnosis of stone position by liver segments showing

similar results. Nguyen Viet Thanh’s study also showed similar

results: sensitivity (Se) 90.9%, specificity (Sp) 91.2%, accuracy

(Acc) 91.1%, positive predictive value (PPV) 81.6%, negative

predictive value (NPV) 95.9%.

* Left intrahepatic bile duct stone position

The diagnosis of left intrahepatic bile duct stone position by

MRCP had the sensitivity (Se) of 96.49%, the specificity (Sp) of

88.88%, the accuracy (ACC) of 94.04% , the positive predictive

value (PPV) of 94.82%, the negative predictive value (NPV) of

92.30%. This result is equivalent to the study of Nguyen Viet Thanh,

15

with the sensitivity (Se) of 100%, the specificity (Sp) of 93.2%, the

accuracy (ACC) of 96. 5%, the positive predictive value (PPV) of

93.5%, and negative predictive value (NPV) of 100%. This result is

also consistent with the study of Nguyen Huu Thinh and Park on

determining the diagnostic value of MRCP by liver segments.

4.1.2. Stone number

The diagnosis of the number of stones by MRCP in the study had

the sensitivity of 77.8%, the specificity of 98.7%, the accuracy of

96.4%, the positive predictive value of 87.5%, and the negative

predictive value of 97.4%. The research results are inferior compared

to Pham Hong Lien's research with MRCP provided accurate

diagnosis of the number of stones (100%).

Study also showed that MRCP also had some limitations including

inability to assess stone migration from the time of imaging to surgery,

high cost, requirement of interpretation by specialists which is only

feasible in major hospitals.

4.1.3. The values of MRCP in the evaluation of biliary strictures

The diagnosis of biliary strictures by MRCP in the study had the

sensitivity of 93.75%, the specificity of 100%, the accuracy of 98.81%,

the positive predictive value of 100%, the negative predictive value of

98.55%. False negative cases were mostly patients with a history of

recurrent cholangitis or biliary tract intervention. Recurrent

inflammation leads to secondary biliary fibrosis causing non-dilation of

post-obstruction bile duct segments and limiting the ability to locate the

strictures. This results are equivalent to the study of Nguyen Huu Thinh

in which the diagnosis of biliary stenosis had the sensitivity and

specificity of 83.3% and 97.1% in the left lateral section, 100% and

100% in the anterior section, 100% and 97.9% in the posterior section.

16

4.2. Results of LS-CCC in the treatment of main bile duct stones.

4.2.1. Intraoperative results

* Trocart insertion

In 80 cases (95.2%), 4 trocarts were used and in 04 patients (4.8%) 5

trocarts were used. In our study, the fourth trocart (10mm) was placed

last, at the projection point of the intended CBD opening to the anterior

abdominal wall. In contrary, other authors often use a 5mm trocar at the

4th trocar position. We used 10mm trocar at the fourth trocar position

because the choledocho-cutaneous channel and eventually the T-tube

drainage would be inserted through this point.

* Placement of choledocho-cutaneous channel.

Success rate of CCC placement

Since this study focused on evaluating the results of using

cholangioscopic stone removal through the CCC, the operation was

considered successful only the stones were removed through a

successfully placed channel. Failure was defined as inability to place

the channel or inability to remove the stones through the channel and

alternative methods were to be used. Placement of the channel was

accomplished in all 84 patients (100%).

Channel placement time

The mean channel placement time was 5.05 ± 2.47 minutes,

ranging from 2 minutes to 15 minutes. The case with longest

placement time was due to the thin bile ducts wall resulting in tearing

the bile duct which required suture repair and replacement.

Difficulties in channel placement

There were 02 patients (2.4%) complicated with biliary tract

injury during channel placement due to thin bile duct wall requiring

suture repair and successful replacement. There were 03 patients

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(3.6%) in whom the channel was dislodged from the common bile

duct because the diameter of stone was greater than that of the

channel. There were no cases with stone or bile spillage into the

abdomen. We maintained the abdominal pressure of 6-8 mmHg so

that if the channel was not tightly fit, the gas would push the water

out and alert the operating surgeon to stop the procedure and replace

the channel.

* Complications

There were 02 patients (2.4%) having intraoperative

complications, including: 01 patient with seromuscular injury of the

colon resulting from adhesiolysis of the adhesion between the colon

and the liver. The injury was successfully repaired by laparoscopic

suturing. This was the case with history of open CBD exploration

once. The patient recovered uneventfully and was discharged home

on the 8th day. 01 patient had biliary hemorrhage due to bile duct

dilatation with stones treated by warm salt saline irrigation.

* Operative time

The mean operative time was 121.85 ± 30.47 mins, ranging from

70 to 200 mins. Our mean operative time is 68 mins longer than that

of Tran Manh Hung’s study which only treated CBD stones. Our

results were equivalent to the study of Nguyen Hoang Bac (117

mins), and Berthou (124 mins). However, our result was 187 minutes

shorter than Lee H.M, Zhu. J (179.7 mins), Nguyen Khac Duc (150

mins), Su Quoc Khoi (139 mins), and Vu Duc Thu (133.6 ± 46.63

mins).

* Cholangioscopy through the choledocho-cutaneous channel

Stone removal using Mirrizi forcep

18

After CBD opening, if there were large CBD stones which could

be easily removed, we would withdraw the 10mm trocart in the right

subcostal region and use Mirizzi forcep to to remove the stones

followed by CCC placement through the same port site.

Stone removal using basket

The rate of basket use in our study was 100% higher than in

previous studies. Due to the large diameter of the CBD (mostly>

10mm (71.4%)), there were no significant differences between

laparoscopic and open surgery in removal of large stones.

Lithotripsy techniques

If the stone size was ≥ 10mm which exceeded the channel size or

if gallstones were tightly fit the bile duct lumen and could not be

removed by basket. electro-hydraulic lithotripsy was used to

fragment the stones before being retrieved.

Flushing technique

In addition to continuous irrigation through the channel of the

cholangioscope, when stones accumulated too much in the bile ducts,

we withdrew the cholangioscope and inserted a 12-14F plastic tube

to flush the bile ducts similar to open surgery.

Biliary strictures

There were 16 patients (19.1%) with biliary strictures, of which

11 patients (13.1%) having severe strictures, 14 patients (16.7%)

having 01 stricture, 2 patients (2.4%) ) has 2 strictures. Our rate of

biliary strictures is lower than that of Vo Dai Dung with 13/43

patients having strictures (30.23%). These strictures were dilated

with stones during surgery and with a balloon or dilatation tube using

the trans T-tube approach.

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Results of cholangioscopic stone removal

The study showed 69 patients (82.1%) with stone clearance

observed by cholangioscopy. However, only 46 patients (54.8%) had

stone clearance confirmed after surgery. The results of the study are

higher than the results of Vo Dai Dung: with intraoperative stone

clearance rate of 39.5% and the postoperative stone clearance rate of

30.23 %.

The cause of retained stones observed by cholangioscopy was

bile duct strictures in 15 patients (17.9%). In case of inability to clear

the stone after stricture dilatation with stones during surgery, trans T-

tube stone removal was used during follow-up.

The mean time of stone removal in the study was 52.50 ± 22.84

(mins), ranging from 10 minutes to 125 minutes. Stone removal time

was significantly longer for group of patient with larger number of

stones(p = 0.0032). Stone removal time directly affected operative

time.

4.2.2. Early results

* Postoperative hospital stay

The mean postoperative hospital stay was 9.48 (days). Our

research results were equivalent to those of Vo Dai Dung (9.65

days), Su Quoc Khoi (10.5 ± 2.7 days).

* Early complications

There were 8 patients (9.6%) having early complications. The

result is higher than that of Nguyen Khac Duc (3.9%), Su Quoc Khoi

(5.8%), Vo Dai Dung (4.7%).

03 patients had subhepatic fluid collection after surgery without

any symptoms, and all were incidentally detected only during

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postoperative ultrasound examination which required no further

intervention.

There was 01 patient (1.2%) having postoperative intestinal

fistula detected on the 4th day after surgery. The volume of the

fistula through the drainage was approximately 100 ml/day. The

patient was treated with Nil by mouth and total parenteral nutrition.

The fistula volume gradually decreased and complete resolution was

noted on the 18th day. This patient had a history of one surgery for

biliary stones. Excessive adhesiolysis or electrocautery caused injury to

the gastrointestinal tract which was unrecognized by the surgeon until day

4.

There was 01 patient (1.2%) with suspected bile leakage having

wet,yellowish wound dressing of the T-tube exit site on the 5th day

after surgery but spontaneously resolving on the 12th day after

surgery. This case did not fulfill all the criteria of bile leakage.

* Stone clearance

Stone clearance rate

The stone clearance rate is the most important indicator of the

treatment results for cholelithiasis. Some authors used the

observations by cholangioscopy to define the postoperative stone

clearance [3], [110]. Our study assess stone clearance using all 3

modalities: cholangioscopy, cholangiography and ultrasound. The

postoperative stone clearance rate of our study was 54.8%.

* Factors related to stone clearance rate

Stone position: The rate of stone clearance was significantly

associated with stone position with p = 0.002. This is similar to the

results of Vo Dai Dung in which stone clearance rate was statistically

21

significantly correlated to stone position with p = 0.01 (Chi - square

tests) [73].

Stone number: the correlation between postoperative stone

clearance rate and the number of stones was statistically significant

with p = 0.029. Our research results are equivalent to that of Vo Dai

Dung, in which postoperative stone clearance rate and the number of

stones was statistically significantly correlated with p = 0.03 (Chi -

square tests).

Biliary strictures: the study showed that there was no patient

achieving stone clearance after surgery in the group having biliary

strictures. Biliary stricture was associated with postoperative stone

clearance and the association was statistical significance with p =

0.00. Vo Dai Dung's study showed similar results with no stone

clearance in biliary stricture group (p = 0.004).

Surgical history: postoperative stone clearance rate and surgical

history were not statistically significantly correlated to each other (p

= 0.711). This result is equivalent to that of Vo Dai Dung in which

the correlation between postoperative stone clearance and surgical

history was not statistically significant (p = 0.29).

4.2.3. Follow-up results

Using ultrasound, there were 58 patients (69%) with stone

clearance at follow-up, which was higher than the postoperative rate

(46 patients with stone clearance). The reason for higher stone

clearance rate was retained stone fragments incompletely flushed

during surgery detected on immediate postoperative ultrasound

which were eventually cleared by self-flushing of the T-tube under

guidance at home. In cases of complete stone clearance on follow-up

ultrasound, the T-tube was withdrawn and patients were discharged

22

home on the same day. There were 26 patients (31%) with retained

stones detected on ultrasound, in which the majority of retained

stones were located in the right liver 11/26 (42.3%) patients. These

patients were admitted for lithotripsy through the T-tube tunnel.

There were 22 patients (26.2%) achieving stone clearance after one

time lithotripsy through the T-tube tunnel, 7 out of 11 patients with

severe bile duct strictures which were dilated with stones and

eventually achieving stone clearance. There were 4 patients (4.8%)

in which we were unable to remove all the stones even after stricture

dilatation. We defined those cases as post-treatment stone retention.

Finally, the stone clearance rate of our study was 95.2%.

4.2.4. Overall treatment result classification

The overall treatment result of the study was classified as good

in 59.5% and fair in 40.5%, which was an encouraging result. It is

very difficult to compare with studies done in Vietnam because the

inclusion criteria was different. Most of the previous studies selected

patients with extra-hepatic main bile duct stones. Nguyen Khac Duc

studied on laparoscopic treatment of extra-hepatic cholelithiasis with

good results in 86.7% and average results in 9.4%.

23

CONCLUSION

Through the study of 84 patients who received laparoscopic

surgery combined with cholangioscopy through choledocho-

cutaneous channel to treat main bile duct stones at 108 Central

Military Hospital, from July 2017 to March 2020, we had the

following conclusions:

1. Value of MRI in the diagnosis of main bile duct stones

The sensitivity, specificity, accuracy, positive predictive value,

negative predictive value of MRI in the diagnosis of stone position

were, respectively: 97.05%; 93.75%; 96.42%; 98.51%; 88.23% for

main extra-hepatic bile duct, 95.65%; 94.73%; 95.23%; 95.65%;

94.73% for right intrahepatic bile ducts, 96.49%; 88.98%; 94.04%;

94.82%, 92.30% for left intrahepatic bile ducts.

The sensitivity, specificity, accuracy, positive predictive value,

negative predictive value of MRI in the diagnosis of the number of

stones were: 77.77%; 98.66%; 96.42%; 87.50%; 97.36%,

respectively.

The sensitivity, specificity, accuracy, positive predictive value,

negative predictive value of MRI in the diagnosis of biliary stenosis

were 93.75%; 100%; 98.81%; 100%; 98.55%, respectively

2. Results of laparoscopic surgery combined with cholangioscopy

through the choledocho-cutaneous channel in the treatment of

main bile duct stones.

* Intraoperative results:

Placement of channel: 100% success, insertion time: 5.05 ± 2.47

minutes (2 - 15 minutes), biliary tract injury during insertion 2.4%,

channel dislodgement during stone removal 3.6%, no cases of bile

and stones spillage into the abdomen

24

Stone removal time: 52.50 ± 22.84 minutes (10 - 125 minutes)

Operative time: 121.85 ± 30.47 minutes (70 - 200 minutes)

Complications: 2.4%

* Early results:

Postoperative pain duration: 1.9 ± 0.53 days (1- 4 days)

Postoperative time to return of bowel function: 2.17 ± 0.82 days

(1- 4 days)

Postoperative hospital stay: 9.48 ± 3,609 days (4 - 24 days)

Postoperative stone clearance rate: 54.8%, postoperative stone

clearance rate was correlated to stone postion, number of stones, bile

duct stricture and not correlated to surgical history

Early complications: 9.6%

* Follow-up results:

Mean follow-up time: 31.77 ± 11.23 (day)

T-tube withdrawn at follow-up 58 patients (69%), hospitalization

for lithotripsy through Kehr tunnel: 26 patients (31%), stone

clearance after one time Kehr tunnel lithotripsy: 22 patients (26.2%)

Post-treatment stone retention: 4 patients (4.8%), final stone

clearance : 80 patients (95.2%)

Overall result: good 59.5%, fair 40.5%

25

RECOMMENDATIONS

Through the research process, we have the following

recommendations:

1. Further study with a larger number of patients, longer follow-up

time is required.

2. It is necessary to be equipped with a 3-mm cholangioscopy in

cases of biliary strictures which can not be approached using a 5.2

mm cholangioscopy.

LIST OF RELATED PUBLICATIONS

1. Le Van Loi, Trieu Trieu Duong, Le Nguyen Khoi (2020),

“Results of laparoscopic surgery combined with

cholangioscopy through choledocho-cutaneosu channel”,

Journal of 108 - Clinical medicine and pharmacy, (15), 6,

pp. 77 - 83.

2. Le Van Loi, Trieu Trieu Duong, Le Nguyen Khoi (2020),

“Values of magnetic resonance imaging in the diagnosis of

main bile duct stones”, Journal of 108 - Clinical medicine

and pharmacy, (15), 6, pp. 147 - 153.