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Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis (CREST Choles)

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ClinicalTrials.gov Identifier: NCT02554097
Recruitment Status : Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
Peking University First Hospital
Xuanwu Hospital, Beijing
Luhe Hospital, Capital Medical University
Peking University Third Hospital
China-Japan Friendship Hospital
Beijing Tongren Hospital
LanZhou University
The First Affiliated Hospital of Dalian Medical University
Shanghai Zhongshan Hospital
Peking University
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Zhongtao Zhang, Beijing Friendship Hospital

Brief Summary:
Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.

Condition or disease Intervention/treatment
Gallstones Cholelithiasis Cholecystolithiasis Choledocholithiasis Procedure: endoscopic sphincterotomy Procedure: laparoscopic common bile duct exploration Procedure: laparoscopic transcystic common bile duct exploration Procedure: laparoscopic cholecystectomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2700 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
Study Start Date : August 2015
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Group/Cohort Intervention/treatment
EST+LC group
Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.
Procedure: endoscopic sphincterotomy
Sphincterotomy (EST) is performed to remove the common bile duct stone.

Procedure: laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed to remove the gallbladder.

LCBDE+LC group
Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.
Procedure: laparoscopic common bile duct exploration
Transductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery.

Procedure: laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed to remove the gallbladder.

LTCBDE+LC group
Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.
Procedure: laparoscopic transcystic common bile duct exploration
A wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok.

Procedure: laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed to remove the gallbladder.




Primary Outcome Measures :
  1. Rate of Adverse outcomes [ Time Frame: 3 years ]
    The patients with complication / the total patients


Secondary Outcome Measures :
  1. Incremental cost-effectiveness ratio [ Time Frame: 3 years ]
    the average incremental cost associated with 1 additional unit of the measure of effect

  2. Hospital stay [ Time Frame: 3 years ]
    The total days in hospital

  3. Acute cholangitis rate [ Time Frame: 30 days ]
    The patients with acute cholangitis / the total patients

  4. Bile leakage rate [ Time Frame: 30 days ]
    The patients with bile juice found in the abdominal cavity after procedures / the total patients

  5. Stricture of the bile duct rate rate [ Time Frame: 3 years ]
    The patients with any stricture appeared after the procedures / the total patients

  6. Mortality [ Time Frame: 3 years ]
    Number of death connected with the procedures and complications / total patients

  7. Perforation Rate [ Time Frame: 30 days ]
    The patients with perforation after the procedures / the total patients

  8. Hemorrhage Rate [ Time Frame: 3 years ]
    The patients with hemorrhage after the procedures / the total patients

  9. Operation time [ Time Frame: 3 years ]
    The total time of all the procedures (min)

  10. Acute pancreatitis Rate [ Time Frame: 30 days ]
    The patients with acute pancreatitis after the procedures / the total patients



Information from the National Library of Medicine

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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
Sampling Method:   Non-Probability Sample
Study Population
Patients are diagnosed with gallstones and common bile duct stones.
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 (MRI、MRCP and CT).
  • Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
  • Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE).

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): NCT02554097


Locations
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China, Beijing
Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Friendship Hospital
Peking University First Hospital
Xuanwu Hospital, Beijing
Luhe Hospital, Capital Medical University
Peking University Third Hospital
China-Japan Friendship Hospital
Beijing Tongren Hospital
LanZhou University
The First Affiliated Hospital of Dalian Medical University
Shanghai Zhongshan Hospital
Peking University
Peking Union Medical College Hospital
Investigators
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Study Chair: Zhongtao Zhang, Doctor Beijing Friendship Hospital

Additional Information:

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Responsible Party: Zhongtao Zhang, Doctor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02554097     History of Changes
Other Study ID Numbers: CR-CREST Choles
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Keywords provided by Zhongtao Zhang, Beijing Friendship Hospital:
laparoscopic transcystic common bile duct exploration
laparoscopic common bile duct exploration
endoscopic sphincterotomy,
cost-effective analysis

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