| CTRI Number |
CTRI/2012/11/003118 [Registered on: 16/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
09/11/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
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to study whether laparoscopic bile duct exploration after failed endoscopy – does it differ from a primary bile duct exploration |
|
Scientific Title of Study
|
A Prospective Study To Compare The Outcomes After Primary Laparoscopic Exploration Of Common Bile Duct And Laparoscopic Exploration Following Failed Endoscopic Stone Extraction In Patients With Concomitant Gall Stones And Common Bile Duct Stones |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Virinder Kumar Bansal |
| Designation |
Additional Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi, India |
| Address |
Room No. 5021, Department of Surgical Disciplines, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126593686 |
| Fax |
01126588324 |
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Virinder Kumar Bansal |
| Designation |
Additional Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi, India |
| Address |
Room No. 5021, Department of Surgical Disciplines, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126593686 |
| Fax |
01126588324 |
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik Rajan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi, India |
| Address |
Department of Surgical Disciplines, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126593686 |
| Fax |
01126588324 |
| Email |
karthikrajan.163@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, New Delhi-29 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Virinder Kumar Bansal |
All India Institute of Medical Sciences, New Delhi, India |
Department of Surgical Disciplines, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI |
01126593686
01126588324
drvkbansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1/2 pateints with concomitant CBD stones and gall stones, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I: Patients with gallstones and common bile duct stones without any prior intervention |
patients will undergo a single staged procedure i.e. laparoscopic cholecystectomy with laparoscopic common bile duct exploration and stone clearance |
| Comparator Agent |
Group II: Patients with gallstones and common bile duct stones with prior attempts at endoscopic stone extraction |
patients will undergo a single staged procedure i.e. laparoscopic cholecystectomy with laparoscopic common bile duct exploration and stone clearance |
| Intervention |
Laparoscopic Common bile duct exploration |
Group I: Patients with gallstones and common bile duct stones without any prior intervention
Group II: Patients with gallstones and common bile duct stones with prior attempts at endoscopic stone extraction
All the patients will undergo a single staged procedure i.e. laparoscopic cholecystectomy with laparoscopic common bile duct exploration and stone clearance
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with both symptomatic gall stones and choledocholithiasis
2.Patients in whom a prior ERCP had failed to extract a CBD stone
Failure of ERCP will be defined as:
1.Unsuitable anatomy such as gastric outlet obstruction, large periampullary diverticulum
2.Failure to cannulate the bile duct
3.Failure to perform adequate sphincterotomy
4.Failure to extract the stone for various reasons such as large stone, impacted stones and/or multiple stones
|
|
| ExclusionCriteria |
| Details |
1.Patients with acute cholecystitis
2.Patients with acute cholangitis
3.Patients with obstructive jaundice with serum bilirubin > 15mg/dl
4.Patients with post ERCP pancreatitis
5.Patients who do not give consent for participate in the study
6.Patients with previous hepatobiliary surgery
7.Patients with morbid obesity
8.Patients with uncorrectable coagulopathy
9.Patients unfit for GA
10.Patients with significant comorbid conditions
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
• To assess the success and complications of laparoscopic CBD exploration for choledocholithiasis after unsuccessful endoscopic stone extraction to extract common bile duct stones
• To compare the success, ease of surgery and complications between primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction
|
All patients will be followed postoperatively at 1 week, 3 months, 6 months and at one year or till the time they are stone free. Postoperative course of the patients will be noted |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Complications, hospital stay, and cost effectiveness |
Post operative |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Introduction The primary challenge in the management of common bile duct (CBD) stones in association with gallstones is to select the best strategy with regard to success, morbidity and cost-effectiveness. With the rapid development of endoscopic and laparoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) combined with LC has become the mainstream treatment for CBD stone and gallstone in most medical centers. With advances in laparoscopic technology, laparoscopic CBD exploration is becoming the procedure of choice for patients with CBD stones in centers with surgeons having adequate laparoscopic experience7. There is insufficient information in the literature on the practice of laparoscopic CBD exploration in cases of endoscopically irretrievable stones. This prospective comparative study has been designed to study the outcomes after primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction. Materials and Methods This study will be carried out in the Department of Surgical Disciplines and Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi. The study will include 80 patients divided into two groups. Group I: Patients with gallstones and common bile duct stones without any prior intervention Group II: Patients with gallstones and common bile duct stones with prior attempts at endoscopic stone extraction All the patients will undergo a single staged procedure i.e. laparoscopic cholecystectomy with laparoscopic common bile duct exploration and stone clearance (LC + LCBDE). Success will be defined as removal of CBD stones and gallbladder by the intended approach in both the groups i.e. laparoscopic removal. The details of the patients and operative details will be entered in pre structured proforma. All patients will be followed postoperatively for a minimum of one year or till the time they are stone free. Postoperative course of the patients will be noted |