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

The University of Texas System (UT)

Status: Completed

Conditions: Pancreatitis

Treatments: Procedure: Early cholecystectomy with IOC; Procedure: Late cholecystectomy with IOC

Study type: Interventional

Funder types: Other

Identifiers

NCT02806297

HSC-MS-15-0719

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Early cholecystectomy with IOC

Experimental group

Description:

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.

Treatment:

Procedure: Early cholecystectomy with IOC

Late cholecystectomy with IOC

Active Comparator group

Description:

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).

Treatment:

Procedure: Late cholecystectomy with IOC