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2021-03-01
2022-03-01
2022-03-01
722
NCT05434520
Rigshospitalet, Denmark
Rigshospitalet, Denmark
OBSERVATIONAL
Relieving the Bile Ducts Prior to Pancreatoduodenectomy
The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy. A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.
Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy. A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-05-28 | N/A | 2022-06-26 |
2022-06-26 | N/A | 2022-06-28 |
2022-06-28 | N/A | 2022-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Preoperative biliary drainage Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy | PROCEDURE: Preoperative biliary drainage (ERC og PTC-aided)
|
| : No preoperative biliary drainage Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Post-operative complication score (Clavien-Dindo) | The prevalence of complications graded according to Clavien-Dindo score after pancreatoduodenectomy. Clavien-Dindo 0 is no complications, Clavien-Dindo 5 means complications resulting in mortality. | During hospital admission, median time 13 days, up to 390 days. |
| 30-day Mortality | 30-day mortality rate post-pancreatoduodenectomy | up to 30 days |
| 90-day Mortality | 90-day mortality rate post-pancreatoduodenectomy | up to 90 days |
| Length of Hospital Stay | Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge. | Days from admission until discharge, up to 390 days, median time 13 days |
| 30-day Readmission | Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy. | up to 30-days from hospital discharge |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Complications following preoperative bile duct drainage | Prevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis | up to 7 days after bile duct drainage |
| Time from Bile Duct Drainage to Pancreatoduodenectomy | Time from Bile Duct Decompression to pancreatoduodenectomy. | Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days |
| Histological Specimen | Histological diagnosis of the resection specimens divided in malignant (ductal adenocarcinoma, cholangiocarcinoma, papillary carcinoma, duodenal adenocarcinoma, neuroendocrine tumor, other pancreatic carcinoma, other malignancy in the pancreas) and benign (IPMN, other benign diseases). | Obtained within 21 days after resection |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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