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Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial.

ABSTRACT: Acute pancreatitis is the recurrent reason for gastrointestinal admission in a clinical urgent setting, it happens secondary to a wide array of pathologies out of which biliary disease stands as one of the most frequent causes for its presentation. Approximately 20% of pancreatitis are of moderate or severe severity. Currently, there is not a clear recommendation on timing for cholecystectomy, either early or delayed. CHISPA is a randomized controlled, parallel-group, superior clinical trial. An intention-to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30±5 days after randomization). The primary endpoint is major complications associated with laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and length of stay in an intensive therapy unit postoperatively (if it applies). The CHISPA trial has been designed to demonstrate that delayed laparoscopic cholecystectomy reduces the rate of complications associated to an episode of severe biliary pancreatitis compared to early laparoscopic cholecystectomy.Trial registration number: NCT06113419.

SUBMITTER: Ramirez-Giraldo C

PROVIDER: S-EPMC10921534 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial.

Ramírez-Giraldo Camilo C Conde Monroy Danny D Daza Vergara José Alejandro JA Isaza-Restrepo Andrés A Van-Londoño Isabella I Trujillo-Guerrero Luisa L

BMJ surgery, interventions, & health technologies 20240307 1

Acute pancreatitis is the recurrent reason for gastrointestinal admission in a clinical urgent setting, it happens secondary to a wide array of pathologies out of which biliary disease stands as one of the most frequent causes for its presentation. Approximately 20% of pancreatitis are of moderate or severe severity. Currently, there is not a clear recommendation on timing for cholecystectomy, either early or delayed. CHISPA is a randomized controlled, parallel-group, superior clinical trial. An ...[more]

PMID: 38463464

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Project description:ImportanceConsidering the lack of equipoise regarding the timing of cholecystectomy in patients with moderately severe and severe acute biliary pancreatitis (ABP), it is critical to assess this issue.ObjectiveTo assess the outcomes of early cholecystectomy (EC) in patients with moderately severe and severe ABP.Design, settings, and participantsThis cohort study retrospectively analyzed real-life data from the MANCTRA-1 (Compliance With Evidence-Based Clinical Guidelines in the Management of Acute Biliary Pancreatitis) data set, assessing 5304 consecutive patients hospitalized between January 1, 2019, and December 31, 2020, for ABP from 42 countries. A total of 3696 patients who were hospitalized for ABP and underwent cholecystectomy were included in the analysis; of these, 1202 underwent EC, defined as a cholecystectomy performed within 14 days of admission. Univariable and multivariable logistic regression models were used to identify prognostic factors of mortality and morbidity. Data analysis was performed from January to February 2023.Main outcomesMortality and morbidity after EC.ResultsOf the 3696 patients (mean [SD] age, 58.5 [17.8] years; 1907 [51.5%] female) included in the analysis, 1202 (32.5%) underwent EC and 2494 (67.5%) underwent delayed cholecystectomy (DC). Overall, EC presented an increased risk of postoperative mortality (1.4% vs 0.1%, P < .001) and morbidity (7.7% vs 3.7%, P < .001) compared with DC. On the multivariable analysis, moderately severe and severe ABP were associated with increased mortality (odds ratio [OR], 361.46; 95% CI, 2.28-57 212.31; P = .02) and morbidity (OR, 2.64; 95% CI, 1.35-5.19; P = .005). In patients with moderately severe and severe ABP (n = 108), EC was associated with an increased risk of mortality (16 [15.6%] vs 0 [0%], P < .001), morbidity (30 [30.3%] vs 57 [5.5%], P < .001), bile leakage (2 [2.4%] vs 4 [0.4%], P = .02), and infections (12 [14.6%] vs 4 [0.4%], P < .001) compared with patients with mild ABP who underwent EC. In patients with moderately severe and severe ABP (n = 108), EC was associated with higher mortality (16 [15.6%] vs 2 [1.2%], P < .001), morbidity (30 [30.3%] vs 17 [10.3%], P < .001), and infections (12 [14.6%] vs 2 [1.3%], P < .001) compared with patients with moderately severe and severe ABP who underwent DC. On the multivariable analysis, the patient's age (OR, 1.12; 95% CI, 1.02-1.36; P = .03) and American Society of Anesthesiologists score (OR, 5.91; 95% CI, 1.06-32.78; P = .04) were associated with mortality; severe complications of ABP were associated with increased mortality (OR, 50.04; 95% CI, 2.37-1058.01; P = .01) and morbidity (OR, 33.64; 95% CI, 3.19-354.73; P = .003).Conclusions and relevanceThis cohort study's findings suggest that EC should be considered carefully in patients with moderately severe and severe ABP, as it was associated with increased postoperative mortality and morbidity. However, older and more fragile patients manifesting severe complications related to ABP should most likely not be considered for EC.

Project description:BackgroundInfected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15-20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention.MethodsPOINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization.DiscussionThe POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.Trial registrationISRCTN, 33682933 . Registered on 6 August 2015. Retrospectively registered.

Project description:BackgroundSurgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis.Methods/designIn this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years.DiscussionThe results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics.Trial registrationThis trial is registered on ClinicalTrials.gov under the identifier NCT01790529.

Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

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Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial.

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Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial.

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