Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Pancreas Cancer Clinical Trial

Official title:

Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434520
• Other study ID #: PDPTC1
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients who had undergone pancreatoduodenectomy

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Biliary Fistula
• Fistula
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Capitol

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	30-day Mortality	30-day mortality rate post-pancreatoduodenectomy	up to 30 days
Primary	90-day Mortality	90-day mortality rate post-pancreatoduodenectomy	up to 90 days
Primary	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
Primary	30-day Readmission	Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.	up to 30-days from hospital discharge
Secondary	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
Secondary	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
Secondary	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