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CTRI Number  CTRI/2019/01/017055 [Registered on: 11/01/2019] Trial Registered Prospectively
Last Modified On: 29/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [endoscopic therapy vs Laparoscopic surgery]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of comparison of endoscopic and surgical removal of large stones in bile duct  
Scientific Title of Study   Comparision of Endoscopic and Laparoscopic removal of Large Bile Duct Stone: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pramod Kumar Garg 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 3111, Academic Section, 3rd floor, All India Institute of Medical Sciences

South
DELHI
110029
India 
Phone  9868397205  
Fax    
Email  pgarg10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SOUMYA JAGANNATH MAHAPATRA 
Designation  Advanced Endoscopy Fellow 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 3111, Academic Section, 3rd floor, All India Institute of Medical Sciences
Room No 219, J P N apex trauma center, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India 
Phone  09990420767  
Fax    
Email  soumyajagannath@yahoo.com  
 
Details of Contact Person
Public Query  
Name  SOUMYA JAGANNATH MAHAPATRA 
Designation  Advanced Endoscopy Fellow 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 3111, Academic Section, 3rd floor, All India Institute of Medical Sciences
Room No 219, J P N apex trauma center, All India Institute of Medical Sciences, New Delhi

DELHI
110029
India 
Phone  09990420767  
Fax    
Email  soumyajagannath@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  Department of Gastroenterology and Department of Surgery 
Address  3rd Floor, Academic section, All India Institute of Medical Science 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Soumya Jagannath Mahapatra   All India Institute of Medical Sciences  1. Room no 3111,3rd Floor, Academic section, Department of Gastroenterology 2. 5th Floor, Academic Section, Department of Surgery
South
DELHI 		 9990420767

soumyajagannath@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical sciences Institute ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K838||Other specified diseases of biliary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoscopic Removal  The endoscopic retrograde cholangiopancreatography (ERCP) technique will be carried out as a day care procedure. All the patients will undergo a preanaesthetic checkup prior to the procedure and will be fasting on the morning of the procedure. The procedure will be performed under monitored anaesthesia care. The ERCP procedure will be performed with a side-viewing duodenoscope (TJF180R; Olympus, Gurgaon, India). Selective cannulation of the bile duct will be achieved using a wire-guided sphincterotome and a hydrophilic guidewire (Terumo, Trivandrum, India, 260 cm, 0.032-in. diameter). After guidewire-assisted cannulation, a contrast dye will be injected to confirm the presence of CBD stones. For extraction of the stones, a biliary sphincterotomy will be performed using a combination current of cutting and coagulation (Endocut; Erbee, Tuebingen, Germany). The stones will be extracted after fragmenting it with a mechanical lithotripter and subsequently using Dormia basket or stone extraction balloon. In case of these methods don’t succeed, laser lithotripsy will be done to fragment the stone through cholangioscopy (Spyglass; Olympus, Gurgaon, India). The stone will be fragmented using Holmium: YAG laser using 0.5- 1.0 J/pulse with a frequency of 10-20 Hz. A check cholangiogram will be performed to confirm complete clearance of the bile duct. In case of incomplete clearance a double pigtail plastic stent will be placed which will be removed in next attempt of ERCP. In second attempt balloon sphincteroplasty will be used to aid in clearance of stone if required. Patients with gall stone will undergo laparoscopic cholecystectomy after clearance of bile duct stone by ERCP. The patients will be kept under observation for 6–8 h after the procedure. Any complications such as perforation, bleeding, pancreatitis, or cholangitis will be noted. The patients will be given preprocedure, oral, broad-spectrum antibiotics from the day before the procedure to 5 days after the procedure.  
Comparator Agent  Laparoscopic removal  The patient will be placed in a supine position. Pneumo-peritoneum will be created using a Veress needle supraumbilically. Five ports will be used with a 10-mm 30° telescope at the umbilicus. The position of the epigastric port (12- mm Excel port; Ethicon, Cincinati, OH, USA) will be slightly different from that used in standard cholecystectomy. The epigastric port will be inserted 2.5 cm to the right of midline so that it was directly in the line of the CBD. Two working ports and an additional 5-mm port will be placed in the left paramedian area just above the umbilicus for insertion of a choledochoscope (rigid) for visualization of upper tracts and closure of choledochotomy. A longitudinal supraduodenal choledochotomy will be made using the Endoknife (Karl-Storz, Tuttlingen, Germany). The stones and debris from the CBD will be removed either by thorough flushing with a copious amount of normal saline or by using forceps. Choledochoscopy will be performed using either a flexible choledochoscope (11-Fr, 30°; Karl-Storz) or a rigid nephroscope (17-Fr, 6°; Karl-Storz) inserted through the epigastric port. Thorough visualization of the upper portion of the CBD, the right and left hepatic ducts, and the secondary and tertiary ducts will be performed. The choledochoscope then will be directed downward to visualize the lower part of the CBD up to the papilla. Any residual stones will be removed using a Dormia basket, a Fogarty catheter, or triflange forceps (through a rigid nephroscope). A mechanical lithotripter will be used to break impacted stones, and the fragments will be removed. A check choledochoscopy will be performed to ensure CBD clearance. The choledochotomy will be closed using absorbable suture (4-0 Vicryl; Ethicon) either primarily or over a T-tube. In patient with gall stone laparoscopic cholecystectomy will be done in same setting.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with a common bile duct stone of size 1.5 cm or more detected on a magnetic resonance cholangiopancreatography (MRCP) with or without gall stones, both pre and post cholecystectomy will be included in the study. 
 
ExclusionCriteria 
Details  1. Presence of acute cholecystitis
2. Presence of acute cholangitis
3. Patients with obstructive jaundice with a serum bilirubin level higher than 10 mg/dl
4. Patients with a CBD diameter less than 10 mm
5. Patients with a history of hepatobiliary surgery other than cholecystectomy
6. Patient with uncorrectable coagulopathy
7. Patient with American Society Anaeathesiology (ASA) class 3 or more
8. Patient refusal to give consent
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be a composite of complete removal of stone in the bile duct by laproscopic CBD exploration (LCE) or endoscopic method, need of more than two attempts of ERCP for bile duct clearance or occurrence of major complication.   at 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. Complications of the intervention
2. Procedure time in minutes
3. Difficulty of the procedure
4. Hospital stay
5.Cost of the procedure
6. Cost effectiveness  		 at 1 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   15/01/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Our previous study has shown that laparoscopic removal has equivalent efficacy as endoscopic removal patients with gall stone and bile duct stone. Bansal et al. Surg Endosc (2014) 28:875–885 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Gall bladder stones are associated with common bile duct (CBD) stones in 7-12% of patients. The preferred method of removal of bile duct stone is endoscopic retrograde cholangiopancreatography (ERCP). However the success rate of bile duct stone removal decreases with increase in size of stone especially ≥ 1.5 cm stones as well as the number of procedures. On the contrary laparoscopic CBD exploration (LCE) is a single stage procedure with the advantage of having cholecystectomy in same setting, but it is associated with complications such as bile leak, conversion to open surgery and prolonged hospitalization. It is not clear which is better for large CBD stone (≥ 1.5 cm). Our aim to compare both the modalities in patients with CBD stone of size 1.5 cm or more. 
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