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Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

Primary Purpose

Choledocholithiasis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopy
Endoscopy
Sponsored by
Hepatopancreatobiliary Surgery Institute of Gansu Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring Cholangiopancreatography, Endoscopic, Common bile duct, Complication, Recurrence, Laparoscopic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first hospital of Lanzhou UniversityRecruiting
  • Union hospital,Tongji medical collage,Huazhong University of science and technologyRecruiting
  • Second Xiangya Hospital, Central South UniversityRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Shandong jiaotong HospitalRecruiting
  • The first affiliated hospital of Xi 'an jiaotong universityRecruiting
  • The First Teaching Hospital of Xinjiang Medical UniversityRecruiting
  • The First Affiliated Hospital, Zhejiang UniversityRecruiting
  • Southwest Hospital of Third Military Medical UniversityRecruiting
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Tianjin Nankai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LCBDE group (single step)

ERCP group (sequential step)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Common bile duct stone recurrence
Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.

Secondary Outcome Measures

The proportion of patients with all stones removed
Operation time
For arm1 (LCBED): the whole process of the operation; for arm2 (LC+ERCP): the total of the two procedures, LC and ERCP
Length of stay in hospital
The total hospitalization costs
Upper abdominal pain after each procedure by Numerical Rating Scale
Hemorrhage
Maintained positive fecal occult blood test appears or Hb decreased by 10g/l
Perforation
CT scan shows retroperitoneal space fluid or gas
Acute cholangitis
Intermittent chills and fever after procedures
Bile leakage
Any bile juice aspirated from the abdominal cavity after procedures
Stricture of the bile duct
Any stricture appears after the procedures
Number of Death connected with the procedures and complications

Full Information

First Posted
July 30, 2015
Last Updated
September 24, 2023
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
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1. Study Identification

Unique Protocol Identification Number
NCT02515474
Brief Title
Comparison of LCBDE vs ERCP + LC for Choledocholithiasis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis
Keywords
Cholangiopancreatography, Endoscopic, Common bile duct, Complication, Recurrence, Laparoscopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LCBDE group (single step)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ERCP group (sequential step)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Other Intervention Name(s)
Laparoscopic common bile duct exploration (LCBDE)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopy
Other Intervention Name(s)
Endoscopic Retrograde cholangiopancreatography (ERCP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Common bile duct stone recurrence
Description
Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
The proportion of patients with all stones removed
Time Frame
Up to 8 hours
Title
Operation time
Description
For arm1 (LCBED): the whole process of the operation; for arm2 (LC+ERCP): the total of the two procedures, LC and ERCP
Time Frame
Up to 8 hours
Title
Length of stay in hospital
Time Frame
Up to 60 days
Title
The total hospitalization costs
Time Frame
Up to 60 days
Title
Upper abdominal pain after each procedure by Numerical Rating Scale
Time Frame
Up to 60 days
Title
Hemorrhage
Description
Maintained positive fecal occult blood test appears or Hb decreased by 10g/l
Time Frame
Up to 60 days
Title
Perforation
Description
CT scan shows retroperitoneal space fluid or gas
Time Frame
Up to 7 days
Title
Acute cholangitis
Description
Intermittent chills and fever after procedures
Time Frame
Up to 5 years
Title
Bile leakage
Description
Any bile juice aspirated from the abdominal cavity after procedures
Time Frame
Up to 60 days
Title
Stricture of the bile duct
Description
Any stricture appears after the procedures
Time Frame
Up to 5 years
Title
Number of Death connected with the procedures and complications
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Li, M.D., Ph.D.
Phone
+86 13993138612
Email
drlixun@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbo Meng, M.D., Ph.D.
Phone
+86 13919177177
Email
mengwb@lzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Li, M.D., Ph.D.
Organizational Affiliation
Hepatopancreatobiliary Surgery Institute of Gansu Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wence Zhou, M.D., Ph.D.
Phone
+868356919
Email
zhouwc129@163.com
First Name & Middle Initial & Last Name & Degree
Wence Zhou, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, M.D., Ph.D.
Facility Name
Union hospital,Tongji medical collage,Huazhong University of science and technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kailin Cai, M. D.
Phone
+8613971086496
Email
caikailin@hust.edu.cn
First Name & Middle Initial & Last Name & Degree
Kailin Cai, M. D.
Facility Name
Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu, M. D.
Phone
+8613873194825
Email
liuwei0217@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei Liu, M. D.
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Wang, M. D.
Phone
+8615804300199
Email
wmgdwk@163.com
First Name & Middle Initial & Last Name & Degree
Meng Wang, M. D.
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Wang, M. D.
Phone
+8613895098592
Email
wq-6562@163.com
First Name & Middle Initial & Last Name & Degree
Qi Wang, M. D.
Facility Name
Shandong jiaotong Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Zhang, M. D.
Phone
+8613805312159
Email
zhangkai.2159@163.com
First Name & Middle Initial & Last Name & Degree
Kai Zhang, M. D.
Facility Name
The first affiliated hospital of Xi 'an jiaotong university
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Sun, M. D.
Phone
+13891813691
Email
sunhaoxjfy@126.com
First Name & Middle Initial & Last Name & Degree
Hao Sun, M. D.
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingmei Shao, M. D.
Phone
+8613579858830
Email
syingmei3000@163.com
First Name & Middle Initial & Last Name & Degree
Yingmei Shao, M. D.
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiyong Li, M. D.
Phone
+8613588451833
Email
liqiyong@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Qiyong Li, M. D.
Facility Name
Southwest Hospital of Third Military Medical University
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leida Zhang, M. D.
Phone
+8613508320249
Email
zld666@aliyun.com
First Name & Middle Initial & Last Name & Degree
Leida Zhang, M. D.
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Wang, M. D.
Phone
+8613601833209
Email
wxxfd@live.cn
First Name & Middle Initial & Last Name & Degree
Xuefeng Wang, M. D.
Facility Name
Tianjin Nankai Hospital
City
Tianjin
ZIP/Postal Code
300100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Wang, M. D.
Phone
+8615302021661
Email
Wangzytj@163.com
First Name & Middle Initial & Last Name & Degree
Zhenyu Wang, M. D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10526025
Citation
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. doi: 10.1007/s004649901145.
Results Reference
background
PubMed Identifier
24162318
Citation
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 Singap. 2013 Sep;42(9):437-44.
Results Reference
background
PubMed Identifier
23871320
Citation
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.
Results Reference
background
PubMed Identifier
20135172
Citation
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.
Results Reference
background
PubMed Identifier
20087351
Citation
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.
Results Reference
background
PubMed Identifier
19792866
Citation
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.
Results Reference
background
PubMed Identifier
12145577
Citation
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.
Results Reference
background

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Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

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