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

NCT02806297 | Completed DMC

• 1 other identifier: HSC-MS-15-0719
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatitis

Keywords

cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 30-day hospital length of stay

  30 days

Secondary Outcomes (9)

• 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

Study Arms (2)

Early cholecystectomy with IOC

EXPERIMENTAL

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

Late cholecystectomy with IOC

ACTIVE COMPARATOR

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

Interventions

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.

Early cholecystectomy with IOC

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).

Late cholecystectomy with IOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

Related Publications (2)

• 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.

  PMID: 31415304 DERIVED

• 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.

  PMID: 29766134 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Lillian S Kao, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 28, 2018
• Study Completion: August 11, 2018
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)