Preoperative Biliary Drainage in Malignant Biliary Obstruction (PEAR)

April 14, 2021 updated by: Szűcs, University of Pecs

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be patients diagnosed with malignant biliary obstruction who meet all the inclusion criteria but no exclusion criteria. All patients admitted with malignant biliary obstruction with- or without biliary intervention prior to the surgery in the participating hospitals will be assessed for eligibility

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Proved metastasis
  2. Irresectable tumor
  3. Neo-adjuvant chemotherapy
  4. Co-existing malignancy
  5. Pregnancy
  6. Patients not fit for resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preoperative biliary drainage and pancreatoduodenectomy
Patients receiving preoperative biliary drainage before the removal of the tumor.
Procedure: Preoperative drainage and pancreatoduodenectomy
Preoperative biliary drainage before surgical removal of the tumor
Pancreatoduodenectomy only
Patients undergoing only surgical intervention, without preoperative drainage.
Procedure: Pancreatoduodenectomy
Pancreatic tumor resection without previous preoperative biliary drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of serious complications
Time Frame: 120 days

rate of serious complications after preoperative biliary drainage and surgery

  1. Pancreatitis
  2. New onset of cholecystitis
  3. Cholangitis
  4. Perforation
  5. Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP)

  6. Related to stent

    1. Occlusion
    2. Need for exchange Related to surgery
  7. Pancreas anastomosis leakage
120 days
rate of serious complications
Time Frame: 120 days

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

  1. Pancreatitis
  2. New onset of cholecystitis
  3. Cholangitis
  4. Perforation
  5. Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP)

  6. Related to stent

    1. Occlusion
    2. Need for exchange Related to surgery
  7. Pancreas anastomosis leakage
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospitalization
Time Frame: 120 days
Length of hospitalization after biliary drainage and surgery
120 days
Mortality
Time Frame: 30 days
Rate of mortality among groups
30 days
Mortality
Time Frame: 120 days
Rate of mortality among the groups
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Péter Hegyi, Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
  • Principal Investigator: Ákos Szűcs, First Surgical Department of the University of Semmelweis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

April 14, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40393-10/2020/EÜIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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