Preoperative Biliary Drainage in Malignant Biliary Obstruction

NCT ID: NCT04847297

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 353 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preoperative biliary drainage and pancreatoduodenectomy

Patients receiving preoperative biliary drainage before the removal of the tumor.

Preoperative drainage and pancreatoduodenectomy

Intervention Type: PROCEDURE

Preoperative biliary drainage before surgical removal of the tumor

Pancreatoduodenectomy only

Patients undergoing only surgical intervention, without preoperative drainage.

Pancreatoduodenectomy

Intervention Type: PROCEDURE

Pancreatic tumor resection without previous preoperative biliary drainage

Interventions

Preoperative drainage and pancreatoduodenectomy

Preoperative biliary drainage before surgical removal of the tumor

Intervention Type: PROCEDURE

Pancreatoduodenectomy

Pancreatic tumor resection without previous preoperative biliary drainage

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Szűcs

Principal Investigator, Associate Professor of the First Surgical Department of the University of Semmelweis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Péter Hegyi

Role: STUDY_CHAIR

Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary

Ákos Szűcs

Role: PRINCIPAL_INVESTIGATOR

First Surgical Department of the University of Semmelweis

Central Contacts

Ákos Szűcs

Role: CONTACT

szucs.akos@gmail.com

06305359443

Péter Hegyi

Role: CONTACT

hegyi2009@gmail.com

06703751031

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Other Identifiers

40393-10/2020/EÜIG

Identifier Type: -

Identifier Source: org_study_id