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Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

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ClinicalTrials.gov Identifier: NCT02515474
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief 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.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Procedure: Laparoscopy Procedure: Endoscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: LCBDE group (single step)
Choledocholithiasis patient, after Laparoscopic Cholecystectomy (LC) to remove the gallbladder, Laparoscopic Common Bile Duct Exploration (LCBDE) was performed for removing the bile duct stone(s) in laparoscopy. Choledochoscope detection or cholangiograms should be chosen as a method of obtain stone clearance. T-tube was acceptable if needed.
Procedure: Laparoscopy
After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.
Other Name: Laparoscopic common bile duct exploration (LCBDE)

Active Comparator: ERCP group (sequential step)
Choledocholithiasis patient, Endoscopic Retrograde cholangiopancreatography (ERCP) was performed for removing the bile duct stone(s) in endoscopy prior to Laparoscopic Cholecystectomy (LC). Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be chosen accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.
Procedure: Endoscopy
Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.
Other Name: Endoscopic Retrograde cholangiopancreatography (ERCP)




Primary Outcome Measures :
  1. Common bile duct stone recurrence [ Time Frame: Up to 5 years ]
    Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.


Secondary Outcome Measures :
  1. The proportion of patients with all stones removed [ Time Frame: Up to 8 hours ]
  2. Operation time [ Time Frame: Up to 8 hours ]
    For arm1 (LCBED): the whole process of the operation; for arm2 (LC+ERCP): the total of the two procedures, LC and ERCP

  3. Length of stay in hospital [ Time Frame: Up to 60 days ]
  4. The total hospitalization costs [ Time Frame: Up to 60 days ]
  5. Upper abdominal pain after each procedure by Numerical Rating Scale [ Time Frame: Up to 60 days ]
  6. Hemorrhage [ Time Frame: Up to 60 days ]
    Maintained positive fecal occult blood test appears or Hb decreased by 10g/l

  7. Perforation [ Time Frame: Up to 7 days ]
    CT scan shows retroperitoneal space fluid or gas

  8. Acute cholangitis [ Time Frame: Up to 5 years ]
    Intermittent chills and fever after procedures

  9. Bile leakage [ Time Frame: Up to 60 days ]
    Any bile juice aspirated from the abdominal cavity after procedures

  10. Stricture of the bile duct [ Time Frame: Up to 5 years ]
    Any stricture appears after the procedures

  11. Number of Death connected with the procedures and complications [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515474


Contacts
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Contact: Xun Li, M.D., Ph.D. +86 13993138612 drlixun@163.com
Contact: Wenbo Meng, M.D., Ph.D. +86 13919177177 mengwb@lzu.edu.cn

Locations
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China, Gansu
The first hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Wence Zhou, M.D., Ph.D.    +868356919    zhouwc129@163.com   
Principal Investigator: Wence Zhou, M.D., Ph.D.         
Sub-Investigator: Wenbo Meng, M.D., Ph.D.         
China, Hubei
Union hospital,Tongji medical collage,Huazhong University of science and technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Kailin Cai, M. D.    +8613971086496    caikailin@hust.edu.cn   
Principal Investigator: Kailin Cai, M. D.         
China, Hunan
Second Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Wei Liu, M. D.    +8613873194825    liuwei0217@gmail.com   
Principal Investigator: Wei Liu, M. D.         
China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Meng Wang, M. D.    +8615804300199    wmgdwk@163.com   
Principal Investigator: Meng Wang, M. D.         
China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Qi Wang, M. D.    +8613895098592    wq-6562@163.com   
Principal Investigator: Qi Wang, M. D.         
China, Shandong
Shandong jiaotong Hospital Recruiting
Jinan, Shandong, China, 250000
Contact: Kai Zhang, M. D.    +8613805312159    zhangkai.2159@163.com   
Principal Investigator: Kai Zhang, M. D.         
China, Shanxi
The first affiliated hospital of Xi 'an jiaotong university Recruiting
Xi'an, Shanxi, China, 710061
Contact: Hao Sun, M. D.    +13891813691    sunhaoxjfy@126.com   
Principal Investigator: Hao Sun, M. D.         
China, Xinjiang
The First Teaching Hospital of Xinjiang Medical University Recruiting
Wulumuqi, Xinjiang, China, 830054
Contact: Yingmei Shao, M. D.    +8613579858830    syingmei3000@163.com   
Principal Investigator: Yingmei Shao, M. D.         
China, Zhejiang
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Qiyong Li, M. D.    +8613588451833    liqiyong@zju.edu.cn   
Principal Investigator: Qiyong Li, M. D.         
China
Southwest Hospital of Third Military Medical University Recruiting
Chongqing, China, 400038
Contact: Leida Zhang, M. D.    +8613508320249    zld666@aliyun.com   
Principal Investigator: Leida Zhang, M. D.         
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
Contact: Xuefeng Wang, M. D.    +8613601833209    wxxfd@live.cn   
Principal Investigator: Xuefeng Wang, M. D.         
Tianjin Nankai Hospital Recruiting
Tianjin, China, 300100
Contact: Zhenyu Wang, M. D.    +8615302021661    Wangzytj@163.com   
Principal Investigator: Zhenyu Wang, M. D.         
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
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Principal Investigator: Xun Li, M.D., Ph.D. Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications:

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Responsible Party: Xun Li, professor of surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT02515474     History of Changes
Other Study ID Numbers: Complications of LCBED vs ERCP
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province:
Cholangiopancreatography
Endoscopic
Common bile duct
Complication
Recurrence
Laparoscopic

Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis