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CTRI Number  CTRI/2023/11/060011 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 16/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Prospective Study of Laparoscopic Cholecystectomy following ERCP in Patients with Gall Bladder Stones and CBD Stones in a Tertiary Care Centre. 
Scientific Title of Study   A prospective Study of Post ERCP Laparoscopic cholecystectomy in patients with Cholelithiasis with choledocholithiasis- An Institutional Experience. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. SWATI PRIYA 
Designation  Junior Resident (Academic) 
Affiliation  Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14 
Address  Room No- 425, Ward- 08, Ward Block , Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna- 800014

Patna
BIHAR
800014
India 
Phone  08789501049  
Fax    
Email  priyaswati.960120@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR KRISHNA GOPAL 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14 
Address  Room No- 425, Ward- 08, Ward Block , Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Patna- 800014, INDIA.

Patna
BIHAR
800014
India 
Phone  8294155575  
Fax    
Email  gopakrishh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KRISHNA GOPAL 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14 
Address  Room No- 425, Ward- 08, Ward Block, Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Patna- 800014, INDIA.

Patna
BIHAR
800014
India 
Phone  8294155575  
Fax    
Email  gopakrishh@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences Sheikhpura Patna 
Address  Room No- 425, Ward- 08, Ward Block, Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Patna- 800014, INDIA. 
Type of Sponsor  Government medical college 
 
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 SWATI PRIYA  Indira Gandhi Institute of Medical Sciences  Room no- 425, Ward- 08, Ward Block, Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-800014.
Patna
BIHAR 
08789501049

priyaswati.960120@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF THE ETHICS COMMITTEE, INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA-14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient willing to participate in the study.
Patient diagnosed with cholelithiasis and choledocholithiasis.
No malformation of biliary tract or previous history of biliary tract surgery.
Patient who have undergone ERCP.
 
 
ExclusionCriteria 
Details  Patient not willing to participate in the study.
Patient less than 18 years.
Patient unable to tolerate general anesthesia.
Patient with severe liver or kidney dysfunction.
Acute pancreatitis or any complication occurring after ERCP.
Patients presenting with acute cholecystitis.
Patients presenting with features of malignancy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess operative time , Intraoperative blood loss, Rate of conversion to open cholecystectomy, Operative difficulties (adhesions, bile and stone spillage, common bile duct injury or distorted Calot’s triangle anatomy encountered) and rates of postoperative complications (wound infection and bile leak).  In patients with cholelithiasis undergoing laparoscopic cholecystectomy within 1 week, till 6 weeks or more than 6 weeks following ERCP for choledocholithiasis. 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the length of post operative hospital stay.  In patients with cholelithiasis undergoing laparoscopic cholecystectomy within 1 week, till 6 weeks or more than 6 weeks following ERCP for choledocholithiasis. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/11/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  


Gall stone disease is the most common affliction of gallbladder and biliary tree, affecting 6.12% of the Indian population. However, despite the high prevalence, gallstones often (94%) remain asymptomatic, and are mostly discovered incidentally on abdominal imaging for unrelated diagnoses. The gold standard of care for gall bladder calculi is laparoscopic cholecystectomy (LC) whereas most commonly used minimally invasive technique for common bile duct stones removal is represented by endoscopic retrograde cholangiopancreatography (ERCP). As previously reported, ERCP has a periprocedural complication rate of 9.8% including bleeding and acute pancreatitis 1.7%, infection, hemorrhage, perforation and a procedure-related mortality rate of 1.9% which may efficacy of LC. Due to its intrinsic invasiveness, ERCP should be proposed for those patients with confirmed bile duct stones only. Though ERCP followed by LC is a commonly used procedure, the optimal timing of LC after ERCP is still contentious and there’s no unanimous opinion regarding the timing of these procedures. It is yet not fully been known whether or not the time interval between ERCP and laparoscopic cholecystectomy affect the rate of conversion to open surgery and risk of operative complications. Though there have been reports of longer operating times, increased bleeding, and higher rates of conversion to open surgery. The reasons for these increased risks have also not been fully elucidated, and these risks may be markers of the underlying severity of gallstone disease or because of secondary sequelae of ERCP. Some published literature points towards the inflammation and edema of the extra hepatic biliary tree caused by ERCP as the culprit which makes the dissection of calot’s triangle difficult. The aim of this study was to evaluate the intraoperative findings and postoperative outcomes with respect to time interval (within 1 week, 1 to 6 weeks and more than 6 weeks) between ERCP and lc in patients who are scheduled laparoscopic cholecystectomy after ERCP. The effects of ERCP on laparoscopic cholecystectomy will be studied based on the length of the operation, intraoperative blood loss, operative difficulties, intraoperative complications, conversion to open cholecystectomy, length of post operative hospital stay and post operative complications.

 


 
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