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

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ClinicalTrials.gov Identifier: NCT02806297
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Lillian Kao, The University of Texas Health Science Center, Houston

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

Condition or disease Intervention/treatment Phase
Pancreatitis Procedure: Early cholecystectomy with IOC Procedure: Late cholecystectomy with IOC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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).
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).




Primary Outcome Measures :
  1. 30-day hospital length of stay [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Time from admission to cholecystectomy [ Time Frame: up to 10 days ]
  2. Initial hospital LOS [ Time Frame: up to 30 days ]
  3. Number of participants who underwent conversion to open cholecystectomy [ Time Frame: 30 days ]
  4. Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) [ Time Frame: baseline, 1 week ]
  5. 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 ]
  6. Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ) [ Time Frame: baseline, 1 week ]
  7. Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ) [ Time Frame: baseline, 6 weeks ]
  8. Change in health-related quality of life as assessed by the standard gamble [ Time Frame: baseline, 1 week ]
  9. Change in health-related quality of life as assessed by the standard gamble [ Time Frame: baseline, 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806297


Contacts
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Contact: Lillian S Kao, MD (713) 566-5095 Lillian.S.Kao@uth.tmc.edu

Locations
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United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Contact: Lillian S Kao, MD    713-566-5095    Lillian.S.Kao@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Lillian S Kao, MD The University of Texas Health Science Center, Houston

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lillian Kao, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02806297     History of Changes
Other Study ID Numbers: HSC-MS-15-0719
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Lillian Kao, The University of Texas Health Science Center, Houston:
cholecystectomy

Additional relevant MeSH terms:
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Pancreatitis
Gallstones
Pancreatic Diseases
Digestive System Diseases
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical