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CTRI Number  CTRI/2025/11/097474 [Registered on: 14/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the optimal timing of laparoscopic cholecystectomy after Endoscopic Retrograde Cholangiopancreatography(ERCP) for Choledocholithiasis. Timing for Laparoscopic cholecystectomy used in this study is Early(within 4 days of ERCP) V/S Late(after 6 weeks).  
Scientific Title of Study   TO STUDY OPTIMAL TIMING (EARLY VS DELAYED) OF LAPROSCOPIC CHOLECYSTECTOMY AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR CHOLEDOCHOLITHIASIS: A RANDOMISED CONTROLLED TRIAL. 
Trial Acronym  CETT( CHOLE- ERCP TIMING TRIAL) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Susmita Verma 
Designation  Junior Resident 
Affiliation  Post-Graduate Institute of Medical Education and Research 
Address  DEPARTMENT OF GENERAL SURGERY, Level 5, B- Block, Nehru Hospital, Post-Graduate Institute of Medical Education and Research, Chandigarh 160012 INDIA

Chandigarh
CHANDIGARH
160012
India 
Phone  8299521509  
Fax    
Email  svsusmitaverma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Lileswar Kaman 
Designation  Professor 
Affiliation  Post-Graduate Institute Of Medical Education And Research 
Address  DEPARTMENT OF GENERAL SURGERY, Level 5, B- Block, Nehru Hospital, Post-Graduate Institute of Medical Education and Research. INDIA

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009644  
Fax    
Email  kamanlil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  PROF LILESWAR KAMABN 
Designation  PROFESSOR 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATIONAND RESEARCH 
Address  DEPARTMENT OF GENERAL SURGERY, 5TH LEVEL, B- BLOCK, NEHRU HOSPITAL, PGIMER CHANDIGARH 160012 INDIA

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009644  
Fax    
Email  kamanlil@yahoo.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh, India, PIN code:160012 
 
Primary Sponsor  
Name  Susmita Verma 
Address  DEPARTMENT OF GENERAL SURGERY, Level 5, B- Block, Nehru Hospital, Post-Graduate Institute of Medical Education and Research, Chandigarh, India, PIN CODE-160012 
Type of Sponsor  Other [self] 
 
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 
Dr Susmita Verma  Post-Graduate Institute of Medical Education and Research  DEPARTMENT OF GENERAL SURGERY, Level 5, B- Block, Nehru Hospital, Post-Graduate Institute of Medical Education and Research, Chandigarh, India, PIN CODE-160012
Chandigarh
CHANDIGARH 		 8299521509

svsusmitaverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, CHANDIGARH.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EARLY LAPAROSCOPIC CHOLECYSTECTOMY POST ERCP  Patients with Choledocholithiasis who have undergone ERCP with stone clerarance will undergo laparoscopic Cholecystectomy within 4 days after ERCP 
Comparator Agent  LATE LAPAROSCOPIC CHOLECYSTECTOMY POST ERCP  Patients with Choledocholithiasis who have undergone ERCP with stone clerarance will undergo laparoscopic Cholecystectomy 6 weeks after ERCP 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Who are willing for laparoscopic Cholecystectomy after ERCP
2. Both Sex
3. Age- 18 Years To 80 Years
4. Patients with choledocholithiasis who have undergone ERCP. 
 
ExclusionCriteria 
Details  1. Patients who arenot giving consent
2. patients with Choledocholithiasis with Failed ERCP
3. Patients undergoing open cholecystectomy
3. Post ERCP Patients who have active cholangitis 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Conversion from laparoscopic cholecystectomy to open cholecystectomy in patients with Choledocholithiasis who have undergone ERCP.  Intra-operative assessment 
 
Secondary Outcome  
Outcome  TimePoints 
1. OPERATIVE TIME AND DISSECTION TIME- total operative time defined as time from skin to skin closure. dissection time will be calculated from introduction of laparoscope in the peritoneal cavity till the dissection of GB from liver bed.
2. intraoperative complications comprising of bile ducts, vascular surgery, bowel injury
3. hospital stay-the hospital stay will be calculated as the number of days in the hospital after surgery until the patients is fit for discharge by the operative surgeon.
4. need for a readmission. 		 Intra-Oprative assessment 
 
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   N/A 
Date of First Enrollment (India)   25/11/2025 
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="1"
Months="6"
Days="28" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This randomized controlled study compares early versus delayed laparoscopic cholecystectomy after ERCP in patients with choledocholithiasis. ERCP clears the common bile duct, but delaying cholecystectomy may lead to recurrent biliary attacks and increased operative difficulty due to inflammation and fibrosis around Calot’s triangle. Early surgery may reduce complications, conversion to open surgery, operative time, and hospital stay. 40 patients will be randomized into early (within 4 days) and delayed (after 6 weeks) groups, with operative outcomes and complications assessed. The study aims to determine the safer and more effective timing for surgery to ensure better clinical outcomes and patient recovery.

Patients will be randomized into early and delayed groups for laparoscopic cholecystectomy, with early surgery performed within 4 days after endoscopic retrograde cholangiopancreatography and delayed surgery performed after 6 weeks in cases of cholelithiasis and choledocholithiasis.

Choledocholithiasis mostly results from gallstones passing through the cystic duct into the common bile duct. After the resolution of acute inflammation with medical treatment such as ERCP and stone removal, cholecystectomy should be performed to prevent recurrence. 

The timing of surgery plays an important role. Early (within 4 days) and late (after 6 weeks) laparoscopic cholecystectomy are compared. Early surgery reduces complications seen in delayed surgery. The study compares conversion to open surgery, operative and dissection time, intraoperative complications such as bleeding, bile duct injury, gallbladder perforation, stone or bile spillage, difficulty level according to parkland grading, and the need for readmission and interval events.
 
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