Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?

NCT06388525 | Completed

• 1 other identifier: PostERCPLC
• Study Type: observational
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

In this retrospective study, we aimed to detect of effects of ERCP on outcomes of Laparoscopic Cholecystectomy. Patients underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis were identified and divided into two main groups regarding to have a ERCP procedure prior to surgery or not. To eliminate possible differences in baseline characteristics, patients in ERCP and non-ERCP groups were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and ASA score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself. After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables (indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use)

Conditions

Endoscopic Retrograde Cholangiopancreatography; ERCP-Laparoscopic Cholecystectomy Interval; Number of Preoperative ERCPs; Stone Extraction Status in ERCP Procedures; Biliary Stents; Mechanical Lithotripsy

Keywords

Endoscopic Retrograde Cholangiopancreatography; Laparoscopic Cholecystectomy; Subtotal Cholecystectomy

Outcome Measures

Primary Outcomes (6)

• Conversion to open

  Decision to continue with conventional open surgery despite laparoscopic initiation

  2016-2020

• Subtotal Cholecystectomy

  Decision to complete the procedure with a subtotal cholecystectomy, despite an initial goal of a total cholecystectomy

  2016-2020

• Postoperative Complications

  Any postoperative complications that have a Clavien-Dindo Score greater than or equal to 3

  2016-2020

• Adhesion levels

  Perivesical adhesion status based on descriptions of omental adhesion levels defined by Sugrue et al.

  2016-2020

• Operative time

  Duration of surgical procedure itself

  2016-2020

• Length of hospital stay

  Time spent in hospital until discharge

  2016-2020

Study Arms (2)

ERCP Group

All patients aged 18 years and over who underwent elective cholecystectomy surgery after a prior ERCP with a diagnosis of symptomatic cholelithiasis and whose surgery was started laparoscopically

Procedure: Endoscopic Retrograde Cholangiopancreatography

Standard/Non-ERCP Group

All patients aged 18 years and over who underwent elective cholecystectomy surgery without an ERCP history with a diagnosis of symptomatic cholelithiasis and whose surgery was started laparoscopically

Interventions

Endoscopic Retrograde Cholangiopancreatography PROCEDURE

ERCP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After exclusion, patients first divided to two groups regarding to have a ERCP procedure prior to surgery or not. Age, sex, ASA scores, history of previous abdominal surgery, Charlson Comorbidity Index (CCI) values were included as baseline data. In terms of CCI scores, patients categorized into two subgroups according to CCI scores greater than 3 or not. To eliminate possible differences in baseline characteristics, patients were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and American Society of Anesthesiologists (ASA) score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself.

You may qualify if:

• All patients aged 18 years and over who underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis and whose surgery was started laparoscopically

You may not qualify if:

• Patients with a diagnosis of malignancy, with a history of percutaneous cholecystostomy, who underwent cholecystectomy while being operated for a different indication, and those who were diagnosed with cholecystoenteric fistula during the operation, were excluded from the study.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Yasir Musa Kesgin

  Istanbul Kanuni Sultan Suleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)