Summary of medical doctoral dissertatation: 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

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: A/Prof Dr Trieu Trieu Duong Dr Le Nguyen Khoi Reviewer: 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: Vietnam national library 108 Institute of clinical medical and pharmaceutical sciences library 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 residual abscess formation To overcome these above-mentioned disadvantages, Vo Dai Dung et al had created a choledochocutaneous 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 choledochocutaneous channel in the treatment of main bile duct stones” with two objectives: To study the value of magnetic resonance imaging in the the diagnosis of main bile duct stones To evaluate the results of laparoscopic surgery and cholangioscopic lithotripsy through choledocho-cutaneous channel in the treatment of main bile duct stones Chapter 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% 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, 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 choledochocutaneous 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 Chapter 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 (LSCCC) 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 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 - 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 x tables 2.2.2.3 Results of LS-CCC in the treatment of main bile duct stones * Intraoperative characteristics - Number of trocarts used: trocarts, 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 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 - patient (1.2%), moderate – 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- days) - Time to return of bowel function: 2.17 ± 0.82 days (1- days) 13 - Postoperative hospital stay: 9.48 ± 3.609 days (4 - 24 days) - Postoperative complications: patients (9.6%): including intestinal fistula – patient (1.2%), biliary fistula - 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: 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 14 Chapter 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%), trocarts were used and in 04 patients (4.8%) 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 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 17 (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, patients (2.4%) ) has 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 ... choledochocutaneous channel in the treatment of main bile duct stones? ?? with two objectives: To study the value of magnetic resonance imaging in the the diagnosis of main bile duct stones To evaluate the. .. of laparoscopic surgery and cholangioscopic lithotripsy through choledocho- cutaneous channel in the treatment of main bile duct stones 3 Chapter LITERATURE REVIEW 1.1 The value of magnetic resonance. .. 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