Comparison of LCBDE vs ERCP + LC for Choledocholithiasis
Information source: Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Choledocholithiasis
Intervention: Laparoscopy (Device); Endoscopy (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Hepatopancreatobiliary Surgery Institute of Gansu Province Official(s) and/or principal investigator(s): Xun Li, M.D., Ph.D., Principal Investigator, Affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
Overall contact: Xun Li, M.D., Ph.D., Phone: +86 13993138612, Email: drlixun@163.com
Summary
Protection of Oddi's sphincter remains a huge argument especially in the long term
complications like common bile duct stone recurrence or cholangitis after ERCP, which
determined to destroy the sphincter of Oddi. The purpose of this study is to compare the
long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.
Clinical Details
Official title: A Long Term Complications Comparison of Laparoscopic Common Bile Duct Exploration and Cholecystectomy Versus Sequential ERCP Followed by Laparoscopic Cholecystectomy for Choledocholithiasis: a Multicenter Randomized Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Common bile duct stone recurrence
Secondary outcome: The proportion of patients with all stones removedOperation time Length of stay in hospital The total hospitalization costs Upper abdominal pain after each procedure by Numerical Rating Scale Hemorrhage Perforation Acute cholangitis Bile leakage Stricture of the bile duct Number of Death connected with the procedures and complications
Detailed description:
Cholelithiasis, a common etiology factor responsible for abdominal pain, is highly prevalent
worldwide. According to data from general investigation, the morbidity of cholelithiasis
differs from 2. 36% to 42% in different areas, and about 5% to 29% (average 18%) of all
cholelithiasis cases have both gallbladder stone and common bile duct stone. In the
population with age above 70 years old, 30% of which suffers from gallbladder stone in
China. A causal link between the development of gallbladder stone and common bile duct stone
is that 10% to 15% of gallstone patients have high potential to develop secondary common
bile duct stone. In 1987, the laparoscopic cholecystectomy (LC) came into being as a
revolutionary surgical method. With minimally invasive effect and high safety, LC was soon
accepted as a 'Golden standard' for the treatment of gallbladder stone. Endoscopic
sphincterotomy (EST) was firstly reported by Kawai and Classen in 1970. As of now, the
combination of EST with other endoscopic techniques, such as basket extraction, balloon
dilation and lithotripsy, have significantly improved the stone removal rate from 85% up to
90%, and ERCP has been considered as the optimal method in regard to CBD stone treatment. In
1991, the laparoscopic common bile duct exploration (LCBDE) which reflected the advantage of
rigid scopes had risen to be a very promising minimally invasive alternative for the
treatment of common bile duct (CBD) stone. Currently, there are mainly two kinds of
minimally invasive treatments for choledocholithiasis, which refers to the "one-stage"
laparoscopic method, LCBDE and the "sequential two-stage" method, ERCP followed by LC. Both
methods are able to achieve the same therapeutic purpose. However, there has always been a
controversy about the advantages and disadvantages due to lack of evidence from long-term
follow-ups, especially the difference of long-term complications related to Oddi's sphincter
functional status, which importantly refers to stone recurrence rates and cholangitis.
The potential long-term complications resulted from EST remains an issue now. It is believed
that EST handles Oddi's sphincter stenosis, regurgitation cholangitis, and higher
cholangiocarcinoma risks in a long run. By virtue of ERCP, multiple high stone clearance
rates (87%~97%) were reported, but meanwhile high re-ERCP rates (around 25%) were also
indicated because of stone residual, and whether great stone residual rates was linked to
future stone recurrence and repeated cholangitis is not clear. Several randomized controlled
trial (RCT) studies had compared ERCP plus LC and LCBDE, the results were similar to the
aspects of stone removal rates, costs, and patient acceptance. However, the postoperative
cholangitis rate of one single center study is quite different from another. Moreover, few
studies have related the stone recurrence rate in the long term follow-up. Obviously,
previous RCT studies were limited by few comparison of ERCP followed by LC versus LCBDE in
long-term complications, especially stone recurrence and cholangitis. Therefore, this
multicenter randomize control study is designed prospectively to compare the stone
recurrence and cholangitis rates between ERCP plus LC and LCBDE which can reflects the
valuable of Oddi's sphincter protection during the disease management, further dedicating
the treatment of gallbladder and common duct stone.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18-65 years old
- Choledocholithiasis patient did not perform any operation
- Common bile duct stone less than 2cm in maximum diameter
Exclusion Criteria:
- Unwillingness or inability to consent for the study
- Coagulation dysfunction (INR> 1. 3) and low peripheral blood platelet count (<50×109 /
L) or using anti-coagulation drugs
- Previous EST, EPBD or percutaneous transhepatic biliary drainage (PTBD)
- Prior surgery of Bismuth Ⅱ and Roux-en-Y
- Benign or malignant CBD stricture
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe
liver disease, primary sclerosing cholangitis (PSC), septic shock
- Combined with Mirizzi syndrome and intrahepatic bile duct stones
- Malignancies
- Biliary-duodenal fistula confirmed during ERCP
- Pregnant women
Locations and Contacts
Xun Li, M.D., Ph.D., Phone: +86 13993138612, Email: drlixun@163.com
Southwest Hospital of Third Military Medical University, Chongqing 400038, China; Not yet recruiting Leida Zhang, M. D., Phone: +8613508320249, Email: zld666@aliyun.com Leida Zhang, M. D., Principal Investigator
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China; Not yet recruiting Xuefeng Wang, M. D., Phone: +8613601833209, Email: wxxfd@live.cn Xuefeng Wang, M. D., Principal Investigator
Tianjin Nankai Hospital, Tianjin 300100, China; Not yet recruiting Zhenyu Wang, M. D., Phone: +8615302021661, Email: Wangzytj@163.com Zhenyu Wang, M. D., Principal Investigator
The first hospital of Lanzhou University, Lanzhou, Gansu 730000, China; Not yet recruiting Wence Zhou, M.D., Ph.D., Phone: +868356919, Email: zhouwc129@163.com Wence Zhou, M.D., Ph.D., Principal Investigator Wenbo Meng, M.D., Ph.D., Sub-Investigator
Union hospital,Tongji medical collage,Huazhong University of science and technology, Wuhan, Hubei 430022, China; Not yet recruiting Kailin Cai, M. D., Phone: +8613971086496, Email: caikailin@hust.edu.cn Kailin Cai, M. D., Principal Investigator
Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China; Not yet recruiting Wei Liu, M. D., Phone: +8613873194825, Email: liuwei0217@gmail.com Wei Liu, M. D., Principal Investigator
The First Hospital of Jilin University, Changchun, Jilin 130021, China; Not yet recruiting Meng Wang, M. D., Phone: +8615804300199, Email: wmgdwk@163.com Meng Wang, M. D., Principal Investigator
General Hospital of Ningxia Medical University, Yinchuan, Ningxia 750004, China; Not yet recruiting Qi Wang, M. D., Phone: +8613895098592, Email: wq-6562@163.com Qi Wang, M. D., Principal Investigator
Shandong jiaotong Hospital, Jinan, Shandong 250000, China; Not yet recruiting Kai Zhang, M. D., Phone: +8613805312159, Email: zhangkai.2159@163.com Kai Zhang, M. D., Principal Investigator
The first affiliated hospital of Xi 'an jiaotong university, Xi'an, Shanxi 710061, China; Not yet recruiting Hao Sun, M. D., Phone: +13891813691, Email: sunhaoxjfy@126.com Hao Sun, M. D., Principal Investigator
The First Teaching Hospital of Xinjiang Medical University, Wulumuqi, Xinjiang 830054, China; Not yet recruiting Yingmei Shao, M. D., Phone: +8613579858830, Email: syingmei3000@163.com Yingmei Shao, M. D., Principal Investigator
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang 310003, China; Not yet recruiting Qiyong Li, M. D., Phone: +8613588451833, Email: liqiyong@zju.edu.cn Qiyong Li, M. D., Principal Investigator
Additional Information
Related publications: Cuschieri A, Lezoche E, Morino M, Croce E, Lacy A, Toouli J, Faggioni A, Ribeiro VM, Jakimowicz J, Visa J, Hanna GB. E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc. 1999 Oct;13(10):952-7. Goh ES, Liang B, Fook-Chong S, Shahidah N, Soon SS, Yap S, Leong B, Gan HN, Foo D, Tham LP, Charles R, Ong ME. Effect of location of out-of-hospital cardiac arrest on survival outcomes. Ann Acad Med Singapore. 2013 Sep;42(9):437-44. Koc B, Karahan S, Adas G, Tutal F, Guven H, Ozsoy A. Comparison of laparoscopic common bile duct exploration and endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for choledocholithiasis: a prospective randomized study. Am J Surg. 2013 Oct;206(4):457-63. doi: 10.1016/j.amjsurg.2013.02.004. Epub 2013 Jul 17. Bansal VK, Misra MC, Garg P, Prabhu M. A prospective randomized trial comparing two-stage versus single-stage management of patients with gallstone disease and common bile duct stones. Surg Endosc. 2010 Aug;24(8):1986-9. doi: 10.1007/s00464-010-0891-7. Epub 2010 Feb 5. Jeon TY, Han ME, Lee YW, Lee YS, Kim GH, Song GA, Hur GY, Kim JY, Kim HJ, Yoon S, Baek SY, Kim BS, Kim JB, Oh SO. Overexpression of stathmin1 in the diffuse type of gastric cancer and its roles in proliferation and migration of gastric cancer cells. Br J Cancer. 2010 Feb 16;102(4):710-8. doi: 10.1038/sj.bjc.6605537. Epub 2010 Jan 19. Noble H, Tranter S, Chesworth T, Norton S, Thompson M. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. J Laparoendosc Adv Surg Tech A. 2009 Dec;19(6):713-20. doi: 10.1089/lap.2008.0428. Sgourakis G, Karaliotas K. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study. Minerva Chir. 2002 Aug;57(4):467-74.
Starting date: August 2015
Last updated: July 31, 2015
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