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NCT Number: NCT05434520

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.

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Key information

Conditions

Pancreas Cancer Biliary Fistula Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgery-Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Capitol, 2100, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who had undergone pancreatoduodenectomy

Exclusion criteria

  • None

Treatment and study plan

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

Primary outcomes

  1. Post-operative complication score (Clavien-Dindo)

    Time frame: 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.

  2. 30-day Mortality

    Time frame: up to 30 days

    30-day mortality rate post-pancreatoduodenectomy

  3. 90-day Mortality

    Time frame: up to 90 days

    90-day mortality rate post-pancreatoduodenectomy

  4. Length of Hospital Stay

    Time frame: 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.

  5. 30-day Readmission

    Time frame: up to 30-days from hospital discharge

    Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.

Secondary outcomes

  1. Complications following preoperative bile duct drainage

    Time frame: up to 7 days after bile duct drainage

    Prevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis

  2. Time from Bile Duct Drainage to Pancreatoduodenectomy

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

    Time from Bile Duct Decompression to pancreatoduodenectomy.

  3. Histological Specimen

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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