Endoscopic Retrograde CholangiopancreatographyNCT06388525
Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?
An observational study of Endoscopic Retrograde Cholangiopancreatography and ERCP-Laparoscopic Cholecystectomy Interval, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography, ERCP-Laparoscopic Cholecystectomy Interval, Number of Preoperative ERCPs
- What is being tested?
- Endoscopic Retrograde Cholangiopancreatography
- Type of treatment
- Surgery or procedure
- How many people
- 426 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All patients aged 18 years and over who underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis and whose surgery was started laparoscopically
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul
About this study
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.
- Conditions
- Endoscopic Retrograde Cholangiopancreatography, ERCP-Laparoscopic Cholecystectomy Interval, Number of Preoperative ERCPs, Stone Extraction Status in ERCP Procedures, Biliary Stents, Mechanical Lithotripsy
- Being tested
- Endoscopic Retrograde Cholangiopancreatography
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Laparoscopic Cholecystectomy, Subtotal Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde CholangiopancreatographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to open
Decision to continue with conventional open surgery despite laparoscopic initiation
Measured: 2016-2020
Subtotal Cholecystectomy
Decision to complete the procedure with a subtotal cholecystectomy, despite an initial goal of a total cholecystectomy
Measured: 2016-2020
Postoperative Complications
Any postoperative complications that have a Clavien-Dindo Score greater than or equal to 3
Measured: 2016-2020
Adhesion levels
Perivesical adhesion status based on descriptions of omental adhesion levels defined by Sugrue et al.
Measured: 2016-2020
Operative time
Duration of surgical procedure itself
Measured: 2016-2020
Length of hospital stay
Time spent in hospital until discharge
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jan 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasir Musa Kesgin, MD, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Yasir Musa Kesgin, Principal investigator, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388525
- Sponsor's protocol ID
- PostERCPLC
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participant data are not publicly available due to institutional policies but are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?
- ClinicalTrials.gov ID
- NCT06388525
- Acronym / sponsor ID
- PostERCPLC
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP Group | – | Procedure: Endoscopic Retrograde CholangiopancreatographyAll 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients aged 18 years and over who underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis and whose surgery was started laparoscopically
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography | Procedure or surgery | ERCP Group |
Primary outcome
Conversion to open
Time frame: 2016-2020
Decision to continue with conventional open surgery despite laparoscopic initiation
Subtotal Cholecystectomy
Time frame: 2016-2020
Decision to complete the procedure with a subtotal cholecystectomy, despite an initial goal of a total cholecystectomy
Postoperative Complications
Time frame: 2016-2020
Any postoperative complications that have a Clavien-Dindo Score greater than or equal to 3
Adhesion levels
Time frame: 2016-2020
Perivesical adhesion status based on descriptions of omental adhesion levels defined by Sugrue et al.
Operative time
Time frame: 2016-2020
Duration of surgical procedure itself
Length of hospital stay
Time frame: 2016-2020
Time spent in hospital until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No. The participant data are not publicly available due to institutional policies but are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasir Musa Kesgin principal investigator
Istanbul Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Retrograde Cholangiopancreatography and ERCP-Laparoscopic Cholecystectomy Interval, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to open (time frame: 2016-2020). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.