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Treatment of Common Bile Duct Stones

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ClinicalTrials.gov Identifier: NCT03442205
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Renyi Qin, Tongji Hospital

Brief Summary:

ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.

Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.


Condition or disease Intervention/treatment Phase
Common Bile Duct Stone Procedure: LC + LCBDE + ENBD + primary closure of CBD Procedure: ERCP technique + LC Procedure: LC + LCBDE + primary closure of CBD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: Group A Procedure: LC + LCBDE + ENBD + primary closure of CBD
LC + LCBDE + ENBD + primary closure of CBD

Experimental: Group B Procedure: ERCP technique + LC
ERCP technique + LC

Experimental: Group C Procedure: LC + LCBDE + primary closure of CBD
LC + LCBDE + primary closure of CBD




Primary Outcome Measures :
  1. Rate of Adverse outcomes [ Time Frame: 24 months ]
    The patients developing complications/ the total patients



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with age between 18 - 80 years.
  • Patients diagnosed with gallstones.
  • Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
  • Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
  • Patients understood the trial and accepted one of the three managements.

Exclusion Criteria:

  • Combined with Mirizzi syndrome and intrahepatic bile duct stones
  • Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
  • History of upper abdominal surgery.
  • Serious heart, brain, lung, metabolic diseases history.
  • Pregnant women.
  • Unwillingness or inability to consent for the study.

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): NCT03442205


Contacts
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Contact: Hang Zhang, doctor +8602783665314 okashiiyo@126.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Renyi Qin, pHD    +8602783665314    ryqin@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Tongji Hospital
Investigators
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Study Chair: Renyi Qin, pHD Tongji Hospital

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Responsible Party: Renyi Qin, Clinical professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03442205     History of Changes
Other Study ID Numbers: TJDBPS03
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Renyi Qin, Tongji Hospital:
Common Bile Duct Stone;
Laparoscopic Common Bile Duct Exploration;
ERCP;

Additional relevant MeSH terms:
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Calculi
Gallstones
Pathological Conditions, Anatomical
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases