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
|
|
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
|
|
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. |