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.

Study Overview

• Status: Completed
• Conditions: Pancreas Cancer; Biliary Fistula; Surgery-Complications
• Intervention / Treatment: Procedure: Preoperative biliary drainage (ERC og PTC-aided)

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 Type: Observational
• Enrollment (Actual): 722

Contacts and Locations

Study Locations

• Denmark
  • Capitol
    • Copenhagen, Capitol, Denmark, 2100
      • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who had undergone pancreatoduodenectomy from January 1st, 2015 to September 31, 2021

Description

Inclusion Criteria:

• All patients who had undergone pancreatoduodenectomy

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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); Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC
No preoperative biliary drainage; Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: May 28, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: complications; pancreatoduodenectomy; percutaneous transhepatic biliary drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Neoplasms; Biliary Fistula
• Other Study ID Numbers: PDPTC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The datasets generated and/or analyzed during the current study are not publicly available due to a restriction agreement with the Danish Data Protection Agency but are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No