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

A Randomized 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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis
• Intervention / Treatment: Procedure: Early cholecystectomy with IOC; Procedure: Late cholecystectomy with IOC

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day hospital length of stay	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from admission to cholecystectomy	up to 10 days
Initial hospital LOS	up to 30 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, 1 week
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, 1 week
Change in health-related quality of life as assessed by the standard gamble	baseline, 6 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Lillian S Kao, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Mueck KM, Wei S, Pedroza C, Bernardi K, Jackson ML, Liang MK, Ko TC, Tyson JE, Kao LS. Gallstone Pancreatitis: Admission Versus Normal Cholecystectomy-a Randomized Trial (Gallstone PANC Trial). Ann Surg. 2019 Sep;270(3):519-527. doi: 10.1097/SLA.0000000000003424.
• Mueck KM, Wei S, Liang MK, Ko TC, Tyson JE, Kao LS. Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital. Trauma Surg Acute Care Open. 2018 Jan 20;3(1):e000152. doi: 10.1136/tsaco-2017-000152. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): August 11, 2018

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Pancreatitis; Gallstones
• Other Study ID Numbers: HSC-MS-15-0719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES