Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

NCT02515474 | Completed DMC

• 1 other identifier: Complications of LCBED vs ERCP
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 12

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.

Conditions

Choledocholithiasis

Keywords

Cholangiopancreatography; Endoscopic; Common bile duct; Complication; Recurrence; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Common bile duct stone recurrence

  Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.

  Up to 5 years

Secondary Outcomes (11)

• The proportion of patients with all stones removed

  Up to 8 hours

• Operation time

  Up to 8 hours

• Length of stay in hospital

  Up to 60 days

• The total hospitalization costs

  Up to 60 days

• Upper abdominal pain after each procedure by Numerical Rating Scale

  Up to 60 days

Study Arms (2)

LCBDE group (single step)

ACTIVE COMPARATOR

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

ERCP group (sequential step)

ACTIVE COMPARATOR

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

Interventions

Laparoscopy PROCEDURE

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.

Also known as: Laparoscopic common bile duct exploration (LCBDE)

LCBDE group (single step)

Endoscopy PROCEDURE

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.

Also known as: Endoscopic Retrograde cholangiopancreatography (ERCP)

ERCP group (sequential step)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Choledocholithiasis patient did not perform any operation
• Common bile duct stone less than 2cm in maximum diameter

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (12)

The first hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Union hospital,Tongji medical collage,Huazhong University of science and technology

Wuhan, Hubei, 430022, China

Location

Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Shandong jiaotong Hospital

Jinan, Shandong, 250000, China

Location

The first affiliated hospital of Xi 'an jiaotong university

Xi’an, Shanxi, 710061, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Southwest Hospital of Third Military Medical University

Chongqing, 400038, China

Location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Location

Tianjin Nankai Hospital

Tianjin, 300100, China

Location

Related Publications (7)

• 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.

  PMID: 10526025 BACKGROUND

• 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.

  PMID: 24162318 BACKGROUND

• 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.

  PMID: 23871320 BACKGROUND

• 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.

  PMID: 20135172 BACKGROUND

• 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.

  PMID: 20087351 BACKGROUND

• 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.

  PMID: 19792866 BACKGROUND

• 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.

  PMID: 12145577 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Recurrence

Interventions

Laparoscopy; Endoscopy; Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Digestive System Surgical Procedures

Study Officials

• Xun Li, M.D., Ph.D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of surgery

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 4, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)