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NCT Number: 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

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

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Key information

Conditions

Acute Calculous Cholecystitiis (ACC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Luca Ansaloni, MD

CONTACT

[email protected]

+390382502530

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELC + Spyglass cholangiography

Procedure

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.

ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

Procedure

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 outcomes

  1. Timing of ELC after diagnosis of ACC

    Time frame: At the end of the procedures.

    The rate of patients who perform ELC within 72 hours after ACC diagnosis.

Secondary outcomes

  1. 30-day postoperative complication rate according to Clavien Dindo

    Time frame: Day 30

  2. 30-day postoperative biliary complication rate

    Time frame: Day 30

  3. 30-day postoperative mortality rate

    Time frame: Day 30

  4. Intraoperative complication rate

    Time frame: Day 0

  5. Failure rate of performing the procedure

    Time frame: Day 0

  6. Operative times

    Time frame: Day 0

  7. Conversion to open surgery rate

    Time frame: Day 0

  8. Need of ERCP after in LC + Spyglass cholangiography group

    Time frame: immediately after the procedures, Day 30, 6 months

  9. Postoperative length of stay (PO-LOS)

    Time frame: immediately after the procedures

  10. Total length of stay (T-LOS)

    Time frame: immediately after the procedures

  11. Total readmission rate within 6 months

    Time frame: 6 Months after procedure

  12. Readmission rate within 6 months due to Gallstones Relates Events (GRE)

    Time frame: 6 Months after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Ansaloni, MD

CONTACT

[email protected]

+39 0382 50 2530

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: INACCESSIBLE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.