Skip to main content
OpenTrials
Completed

NCT Number: NCT02806297

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:
  • upper abdominal pain, nausea, vomiting, and epigastric tenderness
  • absence of ethanol abuse
  • elevated lipase level above the upper limit of normal (>370 U/L)
  • 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

Treatment and study plan

Early cholecystectomy with IOC

Procedure

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.

Late cholecystectomy with IOC

Procedure

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).

Primary outcomes

  1. 30-day hospital length of stay

    Time frame: 30 days

Secondary outcomes

  1. Time from admission to cholecystectomy

    Time frame: up to 10 days

  2. Initial hospital LOS

    Time frame: up to 30 days

  3. Number of participants who underwent conversion to open cholecystectomy

    Time frame: 30 days

  4. Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)

    Time frame: baseline, 1 week

  5. 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

  6. Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)

    Time frame: baseline, 1 week

  7. Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)

    Time frame: baseline, 6 weeks

  8. Change in health-related quality of life as assessed by the standard gamble

    Time frame: baseline, 1 week

  9. Change in health-related quality of life as assessed by the standard gamble

    Time frame: baseline, 6 weeks

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2016
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.