Clinical trial NCT02806297: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis
Keywords: cholecystectomy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 30-day hospital length of stay
timeFrame: 30 days
Secondary outcomes:
measure: Time from admission to cholecystectomy
timeFrame: up to 10 days
measure: Initial hospital LOS
timeFrame: up to 30 days
measure: Number of participants who underwent conversion to open cholecystectomy
timeFrame: 30 days
measure: Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)
timeFrame: baseline, 1 week
measure: Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire (PESQ)
timeFrame: baseline, 6 weeks
measure: Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
timeFrame: baseline, 1 week
measure: Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)
timeFrame: baseline, 6 weeks
measure: Change in health-related quality of life as assessed by the standard gamble
timeFrame: baseline, 1 week
measure: Change in health-related quality of life as assessed by the standard gamble
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lillian S Kao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.