Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Early cholecystectomy with IOC
The experimental arm will be laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) on admission within 24 hours of presentation regardless of whether pain or tenderness are present or laboratory values are elevated.
  • Procedure: Early cholecystectomy with IOC
    The intervention will be laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) on admission within 24 hours of presentation regardless of whether pain or tenderness are present or laboratory values are elevated.
Active Comparator
Late cholecystectomy with IOC
The comparator will be laparoscopic cholecystectomy with IOC once the patient has met the following criteria: (a) a score of less than 2 on the Visual Analogue Pain Scale, (b) no tenderness on physical exam, and (c) decreased lipase to either less than half of the peak value or within normal range (73-393 U/L).
  • Procedure: Late cholecystectomy with IOC
    The control will be laparoscopic cholecystectomy with IOC once the patient has met the following criteria: (a) a score of less than 2 on the Visual Analogue Pain Scale, (b) no tenderness on physical exam, and (c) decreased lipase to either less than half of the peak value or within normal range (73-393 U/L).

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.