Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Completed

• Conditions: Surgery-Complications; Biliary Fistula; Pancreas Cancer
• Interventions: Procedure: Preoperative biliary drainage (ERC og PTC-aided)

• Registration Number: NCT05434520
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Study First Submitted: 2022-05-28
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-26
• Last Update Submitted: 2022-06-26
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 722

Inclusion Criteria

• All patients who had undergone pancreatoduodenectomy

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preoperative biliary drainage	Preoperative biliary drainage (ERC og PTC-aided)	Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy

Primary Outcome Measures

Name	Time	Method
90-day Mortality	up to 90 days	90-day mortality rate post-pancreatoduodenectomy
Length of Hospital Stay	Days from admission until discharge, up to 390 days, median time 13 days	Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge.
30-day Readmission	up to 30-days from hospital discharge	Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.
Post-operative complication score (Clavien-Dindo)	During hospital admission, median time 13 days, up to 390 days.	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.
30-day Mortality	up to 30 days	30-day mortality rate post-pancreatoduodenectomy

Secondary Outcome Measures

Name	Time	Method
Histological Specimen	Obtained within 21 days after resection	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).
Complications following preoperative bile duct drainage	up to 7 days after bile duct drainage	Prevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis
Time from Bile Duct Drainage to Pancreatoduodenectomy	Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days	Time from Bile Duct Decompression to pancreatoduodenectomy.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Capitol, Denmark