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NCT Number: NCT04847297

Preoperative Biliary Drainage in Malignant Biliary Obstruction

The first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients ≥ 18 years
  • OJ of malignant origin (pancreatic head or periampullary tumor)
  • Total bilirubin level ≥ 40 μmol per liter
  • Signed written informed consent

Exclusion criteria

  • Proved metastasis
  • Irresectable tumor
  • Neo-adjuvant chemotherapy
  • Co-existing malignancy
  • Pregnancy
  • Patients not fit for resection

Treatment and study plan

Preoperative drainage and pancreatoduodenectomy

Procedure

Preoperative biliary drainage before surgical removal of the tumor

Pancreatoduodenectomy

Procedure

Pancreatic tumor resection without previous preoperative biliary drainage

Primary outcomes

  1. rate of serious complications

    Time frame: 120 days

    rate of serious complications after preoperative biliary drainage and surgery

    • Pancreatitis
    • New onset of cholecystitis
    • Cholangitis
    • Perforation
    • Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP)
    • Related to stent
    • Occlusion
    • Need for exchange Related to surgery
    • Pancreas anastomosis leakage

  2. rate of serious complications

    Time frame: 120 days

    rate of serious complications after preoperative biliary drainage and surgery defined as:

    • Pancreatitis
    • New onset of cholecystitis
    • Cholangitis
    • Perforation
    • Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP)
    • Related to stent
    • Occlusion
    • Need for exchange Related to surgery
    • Pancreas anastomosis leakage

Secondary outcomes

  1. Length of hospitalization

    Time frame: 120 days

    Length of hospitalization after biliary drainage and surgery

  2. Mortality

    Time frame: 30 days

    Rate of mortality among groups

  3. Mortality

    Time frame: 120 days

    Rate of mortality among the groups

Study contacts

Contact information is provided by the study sponsor or research team.

Péter Hegyi

CONTACT

[email protected]

06703751031

Ákos Szűcs

CONTACT

[email protected]

06305359443

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study

Acronym: PEAR

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

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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