A Prospective Study of Laparoscopic Cholecystectomy following ERCP in Patients with Gall Bladder Stones and CBD Stones in a Tertiary Care Centre.

Not yet recruiting

Conditions: Calculus of gallbladder and bile duct without cholecystitis,

Registration Number: CTRI/2023/11/060011

Lead Sponsor: Indira Gandhi Institute of Medical Sciences Sheikhpura Patna

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 thereâ€™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 calotâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

Patient not willing to participate in the study.
Patient less than 18 years.
Patient unable to tolerate general anesthesia.
Acute pancreatitis or any complication occurring after ERCP.
Patients presenting with acute cholecystitis.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Calotâ€™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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Indira Gandhi Institute of Medical Sciences
🇮🇳
Patna, BIHAR, India
Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
DR SWATI PRIYA
Principal investigator
08789501049
priyaswati.960120@gmail.com