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SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis (SnapChole)

29. april 2026 opdateret af: European Society for Trauma and Emergency Surgery

This study aims to understand how different treatment approaches for acute gallbladder inflammation (acute calculous cholecystitis) affect patient outcomes in real-world hospital settings.

Acute calculous cholecystitis is a common condition that occurs when gallstones block the gallbladder and cause infection or inflammation. In more severe cases, patients may develop organ dysfunction, and doctors must decide quickly how best to treat the condition. Treatment options include early surgery to remove the gallbladder, placement of a drainage tube, or treatment with antibiotics alone. The best approach is not always clear, especially for patients who are older, have other medical conditions, or are very unwell.

This study will collect information from hospitals around the world about how patients with severe gallbladder inflammation are treated as part of their usual care. No treatments are assigned by the study. All decisions are made by the patient's clinical team.

The goal is to compare outcomes between different treatment approaches in patients who could reasonably receive more than one option. The study will examine recovery, survival, need for additional procedures, and time spent in the hospital over 90 days.

The findings are intended to help doctors and patients better understand which treatment strategies may lead to better outcomes in different clinical situations, and to improve decision-making in emergency surgical care.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

SnapChole is an international, multicenter, prospective, time-bound observational platform study designed to evaluate management strategies and outcomes in adults with acute calculous cholecystitis. The study focuses on patients with severe disease, defined by the presence of organ dysfunction, in whom treatment decisions are influenced by both patient-level factors and system-level capability.

The study is conducted as a prospective clinical audit using routinely collected data and does not alter patient care. Participating centers enroll consecutive eligible patients during a predefined local accrual window. Data are recorded contemporaneously using standardized case report forms and transferred in deidentified form to a central coordinating database. Follow-up extends to 90 days from the index presentation.

The study architecture separates descriptive benchmarking from causal analysis. The full cohort provides a denominator population for characterization of treatment patterns, timing of interventions, and outcomes across centers and healthcare systems. Within this cohort, prespecified analytic subsets are defined at the point of clinical decision-making (time zero), corresponding to the moment at which the treating team determines that one or more management strategies are feasible.

Comparative analyses are structured to align eligibility, treatment assignment, and follow-up, consistent with a target trial emulation framework applied to observational data. Treatment strategies of interest include early cholecystectomy, gallbladder drainage as an initial approach, and antimicrobial-only management. Analyses are restricted to patients in whom the relevant strategies are simultaneously available, in order to reduce bias arising from differences in clinical eligibility or institutional capability.

Exposure is defined as completion of the assigned management strategy within a prespecified interval following the decision point, reflecting real-world delivery of care. Outcomes include days alive and out of hospital at 90 days, mortality, need for additional interventions, and time to achieved source control.

The study also incorporates complementary analyses, including benchmarking of care pathways, evaluation of patient-centered outcomes, and assessment of factors influencing clinical decision-making. Together, these components are intended to provide a comprehensive understanding of how management strategies are selected and how they relate to outcomes in severe acute calculous cholecystitis.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1500

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) presenting to participating centers and managed under routine clinical care. The population reflects patients in whom treatment decisions are influenced by physiologic severity, comorbidity, and institutional capability. Consecutive eligible patients are enrolled prospectively to define a real-world denominator cohort. Analytic subsets are subsequently defined at the attending surgeon-level decision point to evaluate treatment strategies under conditions in which alternative approaches are simultaneously feasible.

Beskrivelse

Inclusion Criteria:

  • Age ≥18 years
  • Presentation with suspected acute calculous cholecystitis
  • Diagnosis confirmed prospectively according to Tokyo Guidelines 2018 (TG18) diagnostic criteria
  • Classified as severe (TG18 Grade III) disease based on the presence of organ dysfunction
  • Managed at a participating center during the study accrual period

Exclusion Criteria:

  • Acalculous cholecystitis
  • Isolated choledocholithiasis or acute cholangitis without cholecystitis
  • Primary gallstone pancreatitis without concomitant acute cholecystitis
  • Elective admission for chronic biliary symptoms
  • Prior cholecystectomy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Full Platform Cohort
Consecutive adult patients presenting with acute calculous cholecystitis and meeting Tokyo Guidelines 2018 diagnostic criteria, including those with severe (Grade III) disease. This cohort represents the full prospective denominator population and is used for benchmarking of treatment patterns, timing of interventions, and clinical outcomes under routine care. No restrictions are applied based on treatment strategy eligibility.
Dual-Eligible Cohort (Surgery vs Drainage)
Subset of patients with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) in whom both early cholecystectomy and gallbladder drainage are judged feasible and available at the attending surgeon-level decision point (time zero). This cohort forms the analytic population for target trial emulation comparing operative source control with drainage-first strategies. Eligibility is defined prior to treatment assignment.
Nonoperative-Eligible Cohort (Drainage vs Antibiotics)
Subset of patients with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) not selected for immediate surgery but in whom both drainage-first and antimicrobial-only management are feasible at the time of decision. This cohort forms the analytic population for target trial emulation comparing nonoperative management strategies. Eligibility is defined at time zero prior to treatment initiation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Days alive and out of hospital at 90 days
Tidsramme: 90 days from time zero (attending surgeon-level decision point)
Number of days the participant is alive and not hospitalized during the 90 days following time zero, defined as the attending surgeon-level decision point at which treatment strategy is assigned. Higher values indicate better recovery.
90 days from time zero (attending surgeon-level decision point)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: 90 days from time zero
Death from any cause within the specified follow-up period after time zero, defined as the attending surgeon-level decision point at which treatment strategy is assigned.
90 days from time zero
Failure of Source Control
Tidsramme: Within 90 days from time zero
Persistent or recurrent sepsis requiring escalation of intervention, including conversion to surgery, additional drainage procedures, or reoperation following the initial management strategy.
Within 90 days from time zero
Unplanned biliary reintervention
Tidsramme: within 90 days of time zero
Any unplanned procedural intervention related to biliary disease, including repeat drainage, operative intervention, or endoscopic procedures following the initial management strategy.
within 90 days of time zero
Length of hospital stay
Tidsramme: From hospital admission to hospital discharge, assessed up to 90 days from time zero
Total duration of the index hospital admission measured from admission to discharge.
From hospital admission to hospital discharge, assessed up to 90 days from time zero
Time to achieved source control
Tidsramme: From time zero to completion of source-control intervention, assessed up to 90 days
Elapsed time from time zero to completion of the definitive source-control intervention, including surgical or drainage procedures.
From time zero to completion of source-control intervention, assessed up to 90 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

European Society for Trauma and Emergency Surgery

Samarbejdspartnere

University of Pennsylvania

Efterforskere

  • Studiestol: Gary A Bass, MD, PhD, University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. januar 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SnapChole

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Deidentified individual participant data are collected as part of a prospective international clinical audit and stored in a secure centralized database. Data sharing policies will be developed in accordance with applicable data protection regulations, including GDPR and HIPAA, and will be governed by the study steering committee. Requests for data access may be considered following publication of primary analyses, subject to institutional agreements and ethical approvals.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kolecystitis, akut

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