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

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806297
• Other study ID #: HSC-MS-15-0719
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 11, 2018

Study information

• Verified date: March 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 11, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gallstones
• Pancreatitis

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day hospital length of stay		30 days
Secondary	Time from admission to cholecystectomy		up to 10 days
Secondary	Initial hospital LOS		up to 30 days
Secondary	Number of participants who underwent conversion to open cholecystectomy		30 days
Secondary	Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)		baseline, 1 week
Secondary	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
Secondary	Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)		baseline, 1 week
Secondary	Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)		baseline, 6 weeks
Secondary	Change in health-related quality of life as assessed by the standard gamble		baseline, 1 week
Secondary	Change in health-related quality of life as assessed by the standard gamble		baseline, 6 weeks