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

Overview

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

Full Title of Study: “A Randomized Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

  • 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.
  • 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).

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 30-day hospital length of stay
    • Time Frame: 30 days

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lillian Kao, Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Lillian S Kao, MD, Principal Investigator, The University of Texas Health Science Center, Houston
  • Overall Contact(s)
    • Lillian S Kao, MD, (713) 566-5095, Lillian.S.Kao@uth.tmc.edu

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