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MINISTRY OF EDUCATION AND TRAINING MINISTRY OF MILITARY MILITARY MEDICAL UNIVERSITY SU QUOC KHOI APPLIED RESEARCH OF LAPAROSOCPIC CHOLEDOCHOLITHOTOMY TO TREAT BILIARY TRACT STONES IN KIEN GIANG GENERAL HOSPITAL Speciality: Surgery Code: 72 01 04 SUMMARY OF MEDICAL Ph.D THESIS HA NOI – 2019 HÀ NỘI-NĂM THE RESEARCH WORK ACCOMPLISHED AT MILITARY MEDICAL UNIVERSITY Scientific supervisors: NGUYEN VAN XUYEN, Ph.D, Assoc.Prof DANG VIET DUNG, Ph.D, Assoc.Prof Reviewer 1: Nguyen Tien Quyet, Ph.D, Assoc.Prof Reviewer 2: Nguyen Anh Tuan, Ph.D, Assoc.Prof Reviewer 3: Le Trung Hai, Ph.D, Prof The Thesis will be defended against the Council of Military Medical University at: This thesis can be referred at: - National Library of Vietnam - Library of Military Medical University INTRODUCTION Biliary stones is a common disease in Vietnam as well as in the world Biliary stones in our country are usually primary stones, formed in place, in large numbers, large size, many positions, high rate of intrahepatic stones and recurrence Treatment of biliary tract stones has many different methods but up to now surgery still plays an important role Currently, in our country the biliary tract stones are treated mainly by open surgery, choledocholithotomy and draining Kehr tube Laparoscopic surgery is a new revolution in surgery In 1990, Stoker was the first surgeon to perform laparoscopic choledocholithotomy to treat biliary tract stones Subsequently, many reports of Berthou, Grubnik, Petelin gave good results, the rate of stone clearance from 92 to 96.7% with low accidents and complications Biliary tract stones in our country have different characteristics compared to European - American countries, so even though laparoscopic surgery has advantages such as less pain, quick recovery, but application of laparoscopic surgery to treat primary biliary stones is difficult about indications, surgical technique and especially being to detect and clean stones intraoperative cholangioscopy increases the rate of detecting stones and stone clearance However, the applied research of laparoscopic surgery combining with intraoperative cholangioscopy to to treat bilary tract stones are few, with a small case volumme Therefore, much more research is needed to apply this technique well, especially at the provincial level, which is difficult due to limitations in equipment, qualifications and laparoscopic skills In Kien Giang, laparoscopic surgery for biliary tract stones treatment has not been applied So we carry on research: “Applied research of laparosocpic choledocholithotomy to treat biliary tract stones in Kien Giang General hospital ” to aim for the following objectives: Determination of indications and technical characteristics of laparoscopic choledocholithotomy combined with cholangioscopy in treating biliary tract stones Evaluating the results of laparoscopic choledocholithotomy combined with cholangioscopy in treating biliary tract stones at Kien Giang General Hospital Some new contributions of thesis: - Determination of some main indications of laparoscopic choledocholithotomy combined with cholangioscopy in treating biliary tract stones - Determination of technical characteristics of laparoscopic choledocholithotomy combined with cholangioscopy in treating biliary tract stones - Proving the safety and efficacy of laparoscopic choledocholithotomy combined with cholangioscopy in treating biliary tract stones: high successful rate, increasing rate of stone clearance Frame of thesis The content of the thesis is presented in 123 pages, including chapters Introduction in pages Chapter - Overview in 32 pages Chapter - Objects and methods in 21 pages Chapter – Results in 27 pages Chapter - Discussion in 31 pages Conclusion in pages Proposal in page The thesis has 44 tables, 26 images, charts References in 120 documents Chapter OVERVIEW 1.4.3 Laparoscopic surgery to treat biliary tract stones Two main methods of Laparoscopic surgery to remove biliary tract stones: + Transcystic stones extraction + Removing stones via choledochotomy In addition, some another methods of laparoscopic surgery are indicated for the treatment of primary biliary stones such as: laparoscopic liver resection, hepaticojejunostomy 1.5 Cholangioscopy 1.5.2 Cholangioscopy in laparoscopic surgery to treat biliary tract stones Intraoperative cholangioscopy to determine: whether or not biliary stones remain after removing stones and assess biliary tract, Oddi sphincter, biliary tract mucosa and we can intervene to clean stones such as: electrohydraulic lithotripsy, removal stones with basket via cholangioscopy 1.5.2.2 Cholangioscopy in laparoscopic surgery The removal of stones using a tool based on the surgeon's experience to determine whether or not it has been cleared is difficult Using flexible cholangioscopic technique helps overcome this disadvantage Cholangioscopy in laparoscopic surgery can perform transcystic duct or incision of choledochotomy In 1990, Stoker performed a flexible cholangioscopy in laparoscopic surgery for good results In 2007, Nguyen Hoang Bac performed intraoperative cholangioscopy for 167/168 cases, with result detecting 53.6% remained stones after removing stones by instruments In 2010, Nguyen Khac Duc performed cholangioscopy for 12/158 cases and determined intraoperative stone clearence No the number of these patients has remained stones in postoperative time Cholangioscopy not only diagnoses remnant stones but also helps surgeons choose and use measures to take stones such as using basket, lithotripsy, tools, washing to lower the rate of postoperative retained stones Besides, cholangioscopy as a means to help surgeons to identify intraoperative stone clearance, bile duct mucosa and narrowed bile ducts, thereby deciding to close common bile duct 1.6 Laparoscopic surgery to treat biliary tract stones in the world The main biliary stones in Western countries are usually secondary stones, from the gallbladder falling down, so the stones are usually small, not many tablets, usually common bile duct stones combine with gallstones, stones in low section of CBD and no intrahepatic stones, so transcystic stone extraction is very high, 50.482.5% In contrast, Asian authors have a lower rate of transcystic stone extraction The research and application of laparoscopic surgery to treat biliary tract stones have made much more progress and indication to have been expanded In addition, many studies have control groups to determine the advantages of laparoscopic surgery treating biliary tract stones were perfomed The main biliary stones in Western countries are usually secondary stones, small size, not many tablets, usually common bile duct stones combine with gallstones and no intrahepatic stones Intraoperative cholangioscopy to detect, remove stones or lithotripsy is performed routinely and almost 100% of cases of laparoscopic surgery However, cholangioscopic scope can be performed by specialized flexible scope, rigid endoscopic scope, uterorenoscope or bronchoscope 1.7 Laparoscopic surgery to treat biliary tract stones in Viet Nam In 1999, the hospital of Ho Chi Minh City University of Medicine and Pharmacy performed laparoscopic surgery to treat biliary tract stones by technique using intraabdominal air insufflation and extract stones via transcystic duct and choledochotomy Table 1.6 Laparoscopic surgery to treat biliary tract stones in Viet Nam Author n Success (%) Complication (%) Nguyen Hoang Bac (2007) 168 97,7 6,4 Nguyen Khac Duc (2010) 128 86,49 3,9 99 7,6 Tran Manh Hung (2012) 105 It can be said that since 1998 up to now, the laparoscopic surgery for biliary stones treatment consist of main studies, which are indicated for cases, using many techniques to treat stones Regarding indications, there are many different indications: Nguyen Hoang Bac, Nguyen Khac Duc indicate for reoperative cases but the number of authors is only 15 cases; indications for extrahepatic stones are performed by Nguyen Hoang Bac, Nguyen Khac Duc, Tran Manh Hung Nguyen Hoang Bac appointed for cases of simple choledocholithiasis with size of stone ≥ 20mm Nguyen Khac Duc, Tran Manh Hung only required stone diameter from 8mm to10mm Indications of laparoscopic surgery for simple choledocholithiasis, failure of ERCP were performed by authors but in few numbers Besides, Nguyen Hoang Bac also indicated for intrahepatic stones with a low rate of 33.1% Technical characteristics: Nguyen Hoang Bac performed the removal of stone through cystic duct with the number of 10 cases and through choledochotomy, hepatectomy to intrahepatic stones Nguyen Khac Duc and Tran Manh Hung only performed choledocholithotomy for extrahepatic biliary tract stones Regarding primary closure, no bile drainage was conducted by all authors In terms of cholangioscopy combined with laparoscopic surgery: Tran Manh Hung did not perform, Nguyen Khac Duc, Nguyen Hoang Bac did not perform all cases due to a broken scope This is one of the general limitations of studies Surgical results when pooled analysis including cases of internal and extrahepatic stones, first surgery and reoperation, transcystic stone extraction and choledocholithotomy, drainage and none drainage: Laproscopic surgery to treat biliary tract stones has a success rate ranging from 86.5% to 99.0% The rate of converting to open surgery varies from 1% to 13.5% Intraoperative accidents 1.2 2.75% Postoperative complications 3.91 - 7.6% The characteristics of biliary stone in Vietnam are different from those of Europe and America The author choose choledocholithotomy instead of removing stones through cystic duct laparoscopic surgery has many advantages, but it is necessary to combine intraoperative cholangioscopy to increase the efficiency of stone clearance However, at present, there are few studies evaluating the method of laparoscopic surgery combining with intraoperative cholangioscopy to treat main biliary tract stones This is an urgent need, contributing to improving treatment effectiveness so we this research Chapter SUBJECTS AND METHODS 2.1 Subjects Subjects are patients that have biliary tract stones treated by laparoscopic choledocholithotomy at the General Surgery Department of Kien Giang General Hospital from 2014 to 2018 2.1.1 Inclusion criteria Patients with main biliary tract stones include patients with recurrent stones (reoperation) diagnosed surely and determined location of stones, size of stones and bile ducts by pre-operative computerized tomography Select the following cases: + Simple choledocholithiasis: Choose cases with diameter of choledocholithiasis ≥ 20mm or preoperative ERCP failed + Cholecysto-choledocholithiasis + Choledocholithiasis combines with intrahepatic stones with or without choledolithiasis 2.1.2 Exclusion criteria - Age < 18 years old - Diameter of choledocholithiasis determined on CT < 10mm - Patient have stones in biliary tract cyst - Simple intrahepatic stones, no choledocholithiasis - Contraindication of laparoscopic surgery: coronary artery disease, respiratory failure 2.2 Methods 2.2.1 Study design A prospective descriptive study with longitudinal follow and uncontrol 2.2.2 Sample size Sample size is calculated by the following formula: n ≥ Z2(1- α/2) p(1-p)/d2 Confidence interval: 95%, Z = 1,96; d = 0,05 p: Success rate of laparoscopic choledocholithotomy 86,5 - 97,7% [10], [14], [67] We choose p = 0,95 (95%) The number of patients needed to research at least 73 2.2.4 Technique - Endotracheal anesthesia Patient supine - Surgeon and camera man standing on the left, assistants standing on the right Main steps of laparoscopic surgery: Step 1: Đặt trocar, Air insufflation Step 2: Investigate the abdominal cavity Step 3: Exposure and choledochotomy Step 4: Removing stones Step 5: Cholangioscopy Step 6: Cholecystectomy when indicated Step 7: Place the Kehr tube Step 8: Hoàn thành mổ 2.2.6 Researching on indications + Ratio of first surgery or biliary tract stones reoperation + Ratio of simple choledocholithiasis + Ratio of cholecysto-choledocholithiasis + Ratio of choledocholithiasis combines with intrahepatic stones + Ratio of patients ≥ 70 and < 70 years old + Ratio of preoperative ERCP failed Comparison between groups on operative time, flatus time, pain relief, hospital stay time and rate of stone clearance 12 - Choledocholithiasis, intrahepatic stones: 53/100(53%) cases 3.2.2 Techniqual characteristics of laparoscopic surgery 100% Patient supine, surgeon standing on the left 100% Placing trocars 100% Vertical choledochotomy 100% T- tube drainage 100% Removing stones by instruments and washing 100% Having intraoperative cholangioscopy 100% Interrupted suture to close CBD, using Viryl 3.0 3.2.3 Results of laparoscopic surgery 3.2.3.1 Cholangioscopy in laparoscopic surgery *Determining retained stones, stone clearance: Bảng 3.19 Results of cholangioscopy in laparoscopic surgery Intraoperative cholangioscopy Number (n=100) Ratio (%) Detect retained stones 57/100 57,0 Stone clearance 43/100 43,0 100 100,0 Tổng - Comparing the ratio of residual stone after removing stones with tools in the first surgical group (54.7%) was lower than reoperative group (69.4%) but the difference was not statistically significant with p = 0.533 according to Chi squared test - Comparison of the rate of residual stone detected by cholangioscopy in intrahepatic stone group (84.5%) was higher than extrahepatic stones group (25.5%) and the difference was statistically significant with p = 0,000 * Managing retained stones were detected by cholangioscopy: 32/57(56,1%) cases have intraoperative electric hydraulic lithotripsy 13 Table 3.24 Results of managing retained stones were detected by intraoperative cholangioscopy Results n = 57 Ratio (%) 42/100 42,0 Knowing retained stone 12/100 12,0 True retained stone 3/100 3,0 57 57,0 Stone clearance Retained stone Tổng 3.2.3.2 Operating time Mean operating time: 139,3 ± 50,0 (55-275) minutes -The operating time of reoperative group is longer than the first surgery group and difference is statistically significant with p 20mm is a predictor of ERCP failure and complications of mechanical lithotripsy - 13% [87] We carried out laparoscopic surgery for 26 cases of simple choledocholithiasis with diameter of stone ≥ 20mm with good results 4.2.3 Laparoscopic indication for choledocholithiasis combining with intrahepatic stone We successfully performed laparoscopic surgery with intrahepatic stone 53% and more than Nguyen Hoang Bac’ study, 33.1% The operating time in the intrahepatic stone group was longer 17 than the extrahepatic stone group, which was statistically significant but in terms of flatus time, duration of pain relief, hospital stay time are not statistically significant difference Laparoscopic surgery for cases of intrahepatic stone, if there is a combination of intraoperative cholangioscopy to remove stones and lithotripsy increasing rate of stone clearance from 15.5% to 71.7% 4.2.4 Laparoscopic indication for preoperative ERCP failed We have (6.8%) cases indicated laparosocopic surgery due to preoperative ERCP failed In which, cases with large stones could not be obtained, cases due to diverticulum, one case was caused by basket trapped and broken In case of trouble we had emergency surgery Postoperative results are stable and discharge after days We found that the application of labaproscopic surgery for cases of preoperative ERCP failed is safe, highly successful rate 4.2.5 Laparoscopic indication for reoperation and abdominal scar In our study, there were 41 cases with a history of abdominal surgery with surgical scar on the navel, under the umbilicum, endoscopic surgical scar including cholecystectomy and 39 cases of biliary tract reoperation (once: 29 cases, times: cases and times: 5cases) The rate of biliary tract reoperation was successfully performed 36/39 (92.3%) cases.Although the surgery time is longer, there is no statistically significant difference between the first operative group and reoperative group about rate of residual stone that is dectected by intraoperative cholangioscopy, the rate of postoperative stone clearance, the rate of postoperative residual stone, duration of pain relief, length of hospital stay and no death The indication of laparoscopic surgery for treating biliary tract stone we have identified with Nguyen Hoang Bac: indication of 18 laparoscopic surgery to treat biliary stones without considering whether the patient has biliary surgery or not 4.2.6 Laparoscopic indication for elderly patient Our study, the average age: 56.2 ± 14.9 years, the youngest age is 24 years old, the largest is 89 years old In particular, patients older ≥ 70 years old have 20.4% Comparing between ≥ 70 and

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