Back to resultsTrial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
Primary Purpose
Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early cholecystectomy with IOC
Late cholecystectomy with IOC
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis focused on measuring cholecystectomy
Eligibility Criteria
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
Sites / Locations
- Lyndon B. Johnson General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early cholecystectomy with IOC
Late cholecystectomy with IOC
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
30-day hospital length of stay
Secondary Outcome Measures
Time from admission to cholecystectomy
Initial hospital LOS
Number of participants who underwent conversion to open cholecystectomy
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire (PESQ)
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
Change in health-related quality of life as assessed by the standard gamble
Change in health-related quality of life as assessed by the standard gamble
Full Information
NCT ID
NCT02806297
First Posted
June 13, 2016
Last Updated
March 25, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02806297
Brief Title
Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
Official Title
A Randomized Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
August 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early cholecystectomy with IOC
Arm Type
Experimental
Arm Description
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.
Arm Title
Late cholecystectomy with IOC
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Early cholecystectomy with IOC
Intervention Description
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
Intervention Name(s)
Late cholecystectomy with IOC
Intervention Description
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 Outcome Measure Information:
Title
30-day hospital length of stay
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time from admission to cholecystectomy
Time Frame
up to 10 days
Title
Initial hospital LOS
Time Frame
up to 30 days
Title
Number of participants who underwent conversion to open cholecystectomy
Time Frame
30 days
Title
Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)
Time Frame
baseline, 1 week
Title
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
Title
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
Time Frame
baseline, 1 week
Title
Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
Time Frame
baseline, 6 weeks
Title
Change in health-related quality of life as assessed by the standard gamble
Time Frame
baseline, 1 week
Title
Change in health-related quality of life as assessed by the standard gamble
Time Frame
baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lillian S Kao, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
31415304
Citation
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.
Results Reference
derived
PubMed Identifier
29766134
Citation
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.
Results Reference
derived
Learn more about this trial
Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
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