Relieving the Bile Ducts Prior to Pancreatoduodenectomy

NCT05434520 | Completed DMC

• 1 other identifier: PDPTC1
• Study Type: observational
• Target: 722
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Surgery-Complications; Biliary Fistula

Keywords

pancreatoduodenectomy; complications; percutaneous transhepatic biliary drainage

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Complications following preoperative bile duct drainage

  up to 7 days after bile duct drainage

• Time from Bile Duct Drainage to Pancreatoduodenectomy

  Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days

• Histological Specimen

  Obtained within 21 days after resection

Study Arms (2)

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

Interventions

Preoperative biliary drainage (ERC og PTC-aided) PROCEDURE

Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC

Preoperative biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients who had undergone pancreatoduodenectomy

You may not qualify if:

• None

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capitol, 2100, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2022
• First Posted: June 28, 2022
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

DK (1)