Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06388525 |
| Other study ID # |
PostERCPLC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
April 2024 |
| Source |
Kanuni Sultan Suleyman Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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)
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.
