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Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05434520
Enrollment
722
Registered
2022-06-28
Start date
2021-03-01
Completion date
2022-03-01
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Fistula, Pancreas Cancer, Surgery-Complications

Keywords

pancreatoduodenectomy, complications, percutaneous transhepatic biliary drainage

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.

Interventions

PROCEDUREPreoperative 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

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients who had undergone pancreatoduodenectomy

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
30-day Readmissionup to 30-days from hospital dischargePrevalence of readmission within 30-days after discharge following pancreatoduodenectomy.
30-day Mortalityup to 30 days30-day mortality rate post-pancreatoduodenectomy
90-day Mortalityup to 90 days90-day mortality rate post-pancreatoduodenectomy
Length of Hospital StayDays from admission until discharge, up to 390 days, median time 13 daysAccumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge.
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.

Secondary

MeasureTime frameDescription
Time from Bile Duct Drainage to PancreatoduodenectomyDays from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 daysTime from Bile Duct Decompression to pancreatoduodenectomy.
Histological SpecimenObtained within 21 days after resectionHistological 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 drainageup to 7 days after bile duct drainagePrevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026