Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis

Not Applicable

Completed

• Conditions: Pancreatitis

• Registration Number: NCT02806297
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.

Detailed Description

The purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. Additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. Hypothesis: During index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Primary Completion: 2018-06-28
• Study Completion: 2018-08-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:

  1. upper abdominal pain, nausea, vomiting, and epigastric tenderness
  2. absence of ethanol abuse
  3. elevated lipase level above the upper limit of normal (>370 U/L)
  4. imaging confirmation of gallstones or sludge

• Low predicted mortality using the Bedside Index of Severity in Acute Pancreatitis (BISAP) -Diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications)

• Scheduled for laparoscopic cholecystectomy prior to discharge

• Lack of any very strong indicator for choledocholithiasis based on the American Society for Gastrointestinal Endoscopy (ASGE) guidelines

• Clinical stability as denoted by admission to a non-monitored floor bed.

Exclusion criteria

• Pregnancy
• Severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis
• Chronic pancreatitis
• Native language other than English and Spanish
• Patient refusal to participate

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30-day hospital length of stay	30 days

Secondary Outcome Measures

Name	Time	Method
Time from admission to cholecystectomy	up to 10 days
Number of participants who underwent conversion to open cholecystectomy	30 days
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)	baseline, 1 week
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire (PESQ)	baseline, 6 weeks
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)	baseline, 6 weeks
Change in health-related quality of life as assessed by the standard gamble	baseline, 6 weeks
Initial hospital LOS	up to 30 days

Trial Locations

Locations (1)

Lyndon B. Johnson General Hospital; 🇺🇸 Houston, Texas, United States