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Recruiting NCT06918626

INtraoperative Approach With Eventual Clearance of Common bilE Duct by SpyGlass Discover vs Sequential Strategy in Patients With Acute Calculus Cholecystitis and Intermediate/High Risk of Common BiLE Duct Stone

No phase Interventional Acute Calculous Cholecystitiis (ACC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ELC + Spyglass cholangiography, ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures.
Who it may be relevant to
Registry conditions: Acute Calculous Cholecystitiis (ACC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

INACCESSIBLE trial is a randomized controlled study that compares two different strategies for the treatment of Acute Calculous Cholecystitiis (ACC) patients with high/intermediate risk of CBDS, according to the score by Khoury T (named Israelian Score, IS). If a patient meets the inclusion and exclusion criteria, (s)he will be randomized to receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures (control group) or ELC + Spyglass cholangiography (study group). The follow-up will be performed after 30 days and 6 months from intervention with an outpatient medical examination

Interventions

  • Procedure ELC + Spyglass cholangiography
    Study group (Spyglass Discover). Patients will undergo ELC surgery as soon as the ACC diagnosis has been confirmed. During surgery, intra-operative cholangiograpy (IOC) will be performed in order to exclude the presence of CBDS and in case of confirmation or still suspicion of CBDS, the exploration of the common bile duct and its eventual clearance via Spyglass Discover is carried out during ELC.
  • Procedure ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures
    Control group (ELC sequential treatment after possible clearance of CBDS via ERCP). Following the diagnosis of ACC, patients with CBDS high/intermediate risk are introduced either directly, in case of high risk, or after performing second-level diagnostics (MNR cholangiography or endoscopic ultrasound), in the case of intermediate risk, to the ERCP with the aim of eliminating CBDS preoperatively and then the ELC will be performed.

Primary outcome measures

  • Timing of ELC after diagnosis of ACC [Time frame: At the end of the procedures.]
Secondary outcome measures (12)
  • 30-day postoperative complication rate according to Clavien Dindo [Time frame: Day 30]
  • 30-day postoperative biliary complication rate [Time frame: Day 30]
  • 30-day postoperative mortality rate [Time frame: Day 30]
  • Intraoperative complication rate [Time frame: Day 0]
  • Failure rate of performing the procedure [Time frame: Day 0]
  • Operative times [Time frame: Day 0]
  • Conversion to open surgery rate [Time frame: Day 0]
  • Need of ERCP after in LC + Spyglass cholangiography group [Time frame: immediately after the procedures, Day 30, 6 months]
  • Postoperative length of stay (PO-LOS) [Time frame: immediately after the procedures]
  • Total length of stay (T-LOS) [Time frame: immediately after the procedures]
  • Total readmission rate within 6 months [Time frame: 6 Months after procedure]
  • Readmission rate within 6 months due to Gallstones Relates Events (GRE) [Time frame: 6 Months after procedure]

Eligibility criteria

Inclusion criteria

  • have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
  • have an Israelian Score (IS) for the risk of main bile duct stones of 2 or 3
  • be >18 years old
  • onset of symptoms ≤7 days before Emergency Department (ED) admission
  • provide signed and dated informed consent form
  • be willing to comply with all study procedures and be available for the duration of the study.

Exclusion criteria

  • Pregnancy
  • Patients unwilling to undergo follow-up assessments
  • Patients diagnosed with concomitant cholangitis or pancreatitis
  • Acute cholecystitis not related to a gallstone etiology
  • Onset of symptoms >7 days before ED admission
  • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
  • Biliary peritonitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Identifiers

NCT: NCT06918626 · INACCESSIBLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗