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CompletedNCT06388525Updated Apr 29, 2024

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

An observational study in Endoscopic Retrograde Cholangiopancreatography, ERCP-Laparoscopic Cholecystectomy Interval and Number of Preoperative ERCPs, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
426
Ages
18 Years and older
Sex
All
01

Study 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)

Read the detailed description

All patients aged 18 years and over who underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis and whose surgery was started laparoscopically in a single tertiary reference hospital between January 1, 2016 and January 1, 2020 were identified retrospectively using the hospital data. 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. 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.

The primary outcomes examined in our study were conversion to open and subtotal cholecystectomy, intraoperative adhesion levels and operative time, hospital stay and postoperative complications. Only complications that have a Clavien-Dindo Score greater or equal to 3 were noted as postoperative complication for analyzes. While the patients with no adhesions were considered as group A, the patients with adhesions covering less than 50% of the gallbladder were considered as group B, whereas the patients in whom the gallbladder was completely covered with adhesions were considered as group C.

After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables to the same outcomes. The variables used in each separate subgroup analysis in the ERCP group were as follows: indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use. Information about mechanical lithotripsy was also noted and used for a separate subgroup analysis

For the first subgroups analysis, ERCP group divided into two subgroups regarding the preoperative ERCP indication was cholangitis or not. The second subgroup analysis was based on the ERCP-Laparoscopic cholecystectomy interval and three subgroups determined. Accordingly, for the timing of surgery, the first two weeks after ERCP were classified as early interval, the 2nd and 6th weeks as moderate interval, and the 6 weeks or later after ERCP, as late interval. Each of the number of preoperative ERCPs, extracted stones, and placed biliary stents were also used determinants for shaping the other subgroups. For the design of the last subgroup, patients were divided into two subgroups according to whether or not they had mechanical lithotripsy in their preoperative ERCP.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
426 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureEndoscopic Retrograde Cholangiopancreatography
06

What researchers measure

Primary outcomes

  1. Conversion to open

    Decision to continue with conventional open surgery despite laparoscopic initiation

    Time frame: 2016-2020

  2. Subtotal Cholecystectomy

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

    Time frame: 2016-2020

  3. Postoperative Complications

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

    Time frame: 2016-2020

  4. Adhesion levels

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

    Time frame: 2016-2020

  5. Operative time

    Duration of surgical procedure itself

    Time frame: 2016-2020

  6. Length of hospital stay

    Time spent in hospital until discharge

    Time frame: 2016-2020

07

Study locations

1 site
  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No — The participant data are not publicly available due to institutional policies but are available from the corresponding author on reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06388525
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Yasir Musa Kesgin, MD (MD, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Apr 29, 2024
Start date
Jan 1, 2016
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020
Last update
Apr 29, 2024

Study contacts

Yasir Musa Kesgin
principal investigator · Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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