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Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day hospital length of stay | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:
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
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| Name | Affiliation | Role |
|---|---|---|
| Lillian S Kao, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31415304 | Derived | 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. | |
| 29766134 | 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. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| 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). |
|
| 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 |
| Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ) | baseline, 1 week |
| Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ) | baseline, 6 weeks |
| Change in health-related quality of life as assessed by the standard gamble | baseline, 1 week |
| Change in health-related quality of life as assessed by the standard gamble | baseline, 6 weeks |