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

NCT ID: NCT02806297

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-08-11

Brief Summary

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

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.

Conditions

Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early cholecystectomy with IOC

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Late cholecystectomy with IOC

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Lillian Kao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lillian S Kao, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31415304 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29766134 (View on PubMed)

Other Identifiers

HSC-MS-15-0719

Identifier Type: -

Identifier Source: org_study_id