Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05291923 |
| Other study ID # |
ILBS-POPF-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2022 |
| Est. completion date |
March 5, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Pancreaticoduodenectomy is one of the commonly performed procedure for periampullary
carcinoma/distal cholangio carcinoma/head of pancreas carcinoma. Postoperative pancreatic
fistula remains the most important postoperative complication following pancreatic surgery.
It's severity ranges from biochemical leak to grade C POPF which can lead to mortality.
Radiological and biochemical parameters in early postoperative period predicts the severity
of POPF after pancreatoduodenectomy. In this study, we will be evaluating the biochemical
parameters and imaging findings as predictors of the severity of postoperative pancreatic
fistula after pancreatoduodenectomy in early postoperative period.
Description:
(a) Aim and Objective - The aim of this study is to evaluate the biochemical parameters and
imaging findings as predictors of the severity of postoperative pancreatic fistula after
pancreatoduodenectomy in early postoperative period
Methodology:
1. Study population: All those operated for pancreatoduodenectomy during the period of
December 2021 to May 2023 will be enrolled in this study, meeting the inclusion and
exclusion criteria. On an average 3-4 cases are operated per month in ILBS.
2. Study design: Prospective observational study.
3. Study period: From the date of clearance by the Institutional Ethics Committee, till May
2023.
4. Sample size with justification: All consecutive patients undergoing
pancreatoduodenectomy for the above-mentioned study period (expected sample size 40)
5. Intervention: none.
6. Monitoring and assessment:
1) Definitions: International study group on pancreatic fistula definition of Post-Operative
Pancreatic Fistula POPF) will be used which are as follows: drain output of any measurable
volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times
the serum amylase activity
Variables to be assessed:
Patient characteristics - Age, Sex, Height, Weight, BMI, Serum albumin levels, Pancreatic
parenchymal thickness- at spleno-portal confluence, Indication of Pancreatoduodenectomy -Peri
ampullary mass, head of pancreatic mass, distal cholangiocarcinoma Operative Parameters -
Duration of surgery, Blood Loss, Pancreatic consistency, Intraoperative remnant pancreatic
parenchymal thickness at pancreatojejunostomy site/ spleno portal confluence.
Postoperative measurements -
1. Drain Fluid amylase (POD 1,3 & 5) & serum amylase
2. Serum Procalcitonin, C-reactive protein and albumin (POD 5)
3. Remnant pancreatic parenchymal thickness & change in thickness at pancreaticojejunostomy
site/splenoportal confluence on NCCT abdomen (POD 5)
4. Presence & location of intra-abdominal collection by NCCT abdomen (POD 5)
5. Interventions required if any for management of complications
Statistical Analysis: Data will be entered into Excel Worksheet and statistical analyses will
be performed by SPSS Statistics version 22 (IBM Corp., Armonk, NY). Statistical data will be
represented as frequencies (%) where the continuous variables will be expressed as medians
and interquartile range (IQR). Continuous variables will be compared with the student t test
and Mann-Whitney test as appropriate. Differences between proportions derived from
categorical data will be compared with Chi-square or Fischer's exact test. Variables will be
correlated with clinical outcomes. ROC curve will be used for biochemical markers and imaging
findings Repeated analyses of measures will be applied wherever applicable.
Adverse effects: None
