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

BackgroundThe timing of laparoscopic cholecystectomy (LC) performed after the mild acute biliary pancreatitis (MABP) is still controversial. We conducted a review to compare same-admission laparoscopic cholecystectomy (SA-LC) and delayed laparoscopic cholecystectomy (DLC) after mild acute biliary pancreatitis (MABP).MethodsWe systematically searched several databases (PubMed, EMBASE, Web of Science, and the Cochrane Library) for relevant trials published from 1 January 1992 to 1 June 2018. Human prospective or retrospective studies that compared SA-LC and DLC after MABP were included. The measured outcomes were the rate of conversion to open cholecystectomy (COC), rate of postoperative complications, rate of biliary-related complications, operative time (OT), and length of stay (LOS). The meta-analysis was performed using Review Manager 5.3 software (The Cochrane Collaboration, Oxford, United Kingdom).ResultsThis meta-analysis involved 1833 patients from 4 randomized controlled trials and 7 retrospective studies. No significant differences were found in the rate of COC (risk ratio [RR] = 1.24; 95% confidence interval [CI], 0.78–1.97; p = 0.36), rate of postoperative complications (RR = 1.06; 95% CI, 0.67–1.69; p = 0.80), rate of biliary-related complications (RR = 1.28; 95% CI, 0.42–3.86; p = 0.66), or OT (RR = 1.57; 95% CI, − 1.58–4.72; p = 0.33) between the SA-LC and DLC groups. The LOS was significantly longer in the DLC group (RR = − 2.08; 95% CI, − 3.17 to − 0.99; p = 0.0002). Unexpectedly, the subgroup analysis showed no significant difference in LOS according to the Atlanta classification (RR = − 0.40; 95% CI, − 0.80–0.01; p = 0.05). The gallstone-related complications during the waiting time in the DLC group included gall colic, recurrent pancreatitis, acute cholecystitis, jaundice, and acute cholangitis (total, 25.39%).ConclusionThis study confirms the safety of SA-LC, which could shorten the LOS. However, the study findings have a number of important implications for future practice.

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“…Third, some of the research data were obtained using a formula. A large-scale RCT is currently in progress [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

Same-admission versus delayed cholecystectomy for mild acute biliary pancreatitis: a systematic review and meta-analysis

et al. 2018

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“…TG18 advocates definitive surgical intervention (usually laparoscopic cholecystectomy) on the index admission in patients with acute cholecystitis or biliary pancreatitis, citing both prospective longitudinal studies and retrospective observational studies that demonstrated a significantly lower incidence of disease recurrence, hospital readmission, and overall disease-specific complications when the procedure was performed within 7 days of the onset of symptoms in the appropriate patient (recommending within 72 h as preferable) 5,17,[23][24][25][26][27][28][29][30] . However, 15 (60 per cent) of the 25 centres in the present study estimated that less than half of their patients routinely had index admission cholecystectomy.…”

Section: Discussionmentioning

confidence: 99%

Self-reported and actual adherence to the Tokyo guidelines in the European snapshot audit of complicated calculous biliary disease

et al. 2020

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Background: Complicated acute biliary calculous disease poses clinical challenges. The European Society of Trauma and Emergency Surgery (ESTES) snapshot audit of complicated biliary calculous disease aims to make novel comparisons between self-reported institutional adherence to the Tokyo guidelines (TG18) and 'real-world' contemporary practice across Europe. Methods: A preplanned analysis of a prospective observational multicentre audit that captured patients undergoing emergency admission for complicated biliary calculous disease (complicated cholecystitis, biliary pancreatitis, or choledocholithiasis with or without cholangitis) between 1 and 31 October 2018 was performed. An anonymized survey was administered to participating sites. Results: Following an open call for participation, 25 centres from nine countries enrolled 338 patients. All centres completed the anonymized survey. Fifteen centres (60 per cent) self-reported that a minority of patients were treated surgically on index admission, favouring interval cholecystectomy. This was replicated in the snapshot audit, in which 152 of 338 patients (45⋅0 per cent) underwent index admission cholecystectomy, 17 (5⋅0 per cent) had interval cholecystectomy, and the remaining 169 (50⋅0 per cent) had not undergone surgery by the end of the 60-day follow-up. Centres that employed a dedicated acute care surgery model of care were more likely to perform index admission cholecystectomy compared with a traditional general surgery 'on call' service (57 versus 38 per cent respectively; odds ratio 2⋅14 (95 per cent c.i. 1⋅37 to 3⋅35), P < 0⋅001). Six centres (24 per cent) self-reported routinely performing blood cultures in acute cholecystitis; patient-level audit data revealed that blood cultures were done in 47 of 154 patients (30⋅5 per cent). No centre self-reported omitting antibiotics in the management of acute cholecystitis, and 144 of 154 (93⋅5 per cent) of patients in the snapshot audit received antibiotics during their index admission. Conclusion: Awareness of TG18 recommendations was high, but self-reported adherence and objective snapshot audit data showed low compliance with TG18 in patients with complicated acute biliary calculous disease. Funding information No funding * Members of the ESTES Cohort Studies Group are co-authors of this study and may be found under the heading Collaborators.

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“…12,13 A protocol change occurred in August 2017 which specified a 12-hour observational period between patient enrollment and randomization to ensure that there was no evidence of clinical deterioration from mild to more severe pancreatitis. 10 This change was prompted by two patients who were initially thought to have mild gallstone pancreatitis, but progressed to severe pancreatitis requiring intensive care within the first 12 hours of hospitalization. Neither patient received cholecystectomy prior to clinical deterioration.…”

Section: Introductionmentioning

confidence: 99%

Gallstone Pancreatitis

et al. 2019

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complications, even when performed in the subgroup of patients who have not had resolution of clinical symptoms and laboratory values. 4-7 In these studies, cholecystectomy was performed within 48-72 hours of admission. A recent randomized trial also showed that cholecystectomy within 48 hours of admission regardless of clinical and laboratory resolution led to shorter hospital LOS without increasing complications; however, this trial was terminated after interim analysis at 50% enrollment once the pre-specified effect size was detected, 8 and trials stopped early for benefit typically overestimate treatment effects. 9 Additional randomized trials are needed to confirm the safety and generalizability of early cholecystectomy for predicted mild acute gallstone pancreatitis. Furthermore, there are no prior randomized trials evaluating laparoscopic cholecystectomy within the first 24 hours of admission or in disadvantaged populations treated at safety-net hospitals. The objectives of this pilot randomized trial were: (1) to determine the feasibility of early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values for patients mild gallstone pancreatitis predicted to be mild on admission, and (2) to obtain unbiased estimates of the effect of early cholecystectomy on hospital LOS, complications, and patient-reported outcomes (PROs) in order to determine the need for further evaluation. The hypothesis was that early cholecystectomy during index admission for predicted mild gallstone pancreatitis is feasible and results in shorter 30-day total hospital LOS without an increase in complications. Methods Design A single-center, parallel-group randomized trial () was performed comparing timing of laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) during index admission among patients with predicted mild gallstone pancreatitis. 10 The trial compared cholecystectomy within 24 hours of presentation to cholecystectomy after clinical resolution on outcomes including 30-day hospital LOS, time to surgery, endoscopic retrograde cholangiopancreatography (ERCP) rates, complications, and PROs. Institutional Review Board approval was obtained. Setting The trial was conducted at Lyndon Baines Johnson General Hospital (LBJGH), a 207-bed safety-net hospital in Houston, Texas. LBJGH is a part of the safety-net system for Harris County, Texas, which is the third most populous county in the United States. Approximately 1300 elective and non-elective cholecystectomies are performed per year. Operative capabilities are available 24 hours a day, seven days a week. An on-call attending general surgeon is in house 24-hours a day along with a team of residents and operating room staff dedicated to perform around the clock non-elective general surgery procedures. Study population From June 2016 through June 2018, patients ≥ 18 years of age with predicted mild gallstone pancreatitis who were planned to undergo laparoscopic cholecystectomy prior to discharge Mueck et al.

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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

Cited by 5 publications

References 33 publications

Same-admission versus delayed cholecystectomy for mild acute biliary pancreatitis: a systematic review and meta-analysis

Same-admission versus delayed cholecystectomy for mild acute biliary pancreatitis: a systematic review and meta-analysis

Self-reported and actual adherence to the Tokyo guidelines in the European snapshot audit of complicated calculous biliary disease

Gallstone Pancreatitis

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