Preoperative Biliary Drainage in Malignant Biliary Obstruction

NCT04847297 | Not Yet Recruiting DMC

• 1 other identifier: 40393-10/2020/EÜIG
• Study Type: observational
• Target: 353
• Locations: 0 countries
• Sites: N/A

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

Keywords

pancreatic cancer; biliary drainage; pancreato-duodenectomy

Outcome Measures

Primary Outcomes (2)

• rate of serious complications

  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

  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 Outcomes (3)

• Length of hospitalization

  120 days

• Mortality

  30 days

• Mortality

  120 days

Study Arms (2)

Preoperative biliary drainage and pancreatoduodenectomy

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

Procedure: Preoperative drainage and pancreatoduodenectomy

Pancreatoduodenectomy only

Patients undergoing only surgical intervention, without preoperative drainage.

Procedure: Pancreatoduodenectomy

Interventions

Preoperative drainage and pancreatoduodenectomy PROCEDURE

Preoperative biliary drainage before surgical removal of the tumor

Preoperative biliary drainage and pancreatoduodenectomy

Pancreatoduodenectomy PROCEDURE

Pancreatic tumor resection without previous preoperative biliary drainage

Pancreatoduodenectomy only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead

Related Publications (34)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (serum and plasma) from all patients will be stored in the Biobank in order to study laboratory parameters later if required (eg, the laboratory could not measure it), and in order to build up a biobank for later clinical studies to which all participants will be given informed consent. The samples will be stored at -80°C.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Péter Hegyi

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

  STUDY CHAIR

• Ákos Szűcs

  First Surgical Department of the University of Semmelweis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ákos Szűcs

CONTACT

06305359443; szucs.akos@gmail.com

Péter Hegyi

CONTACT

06703751031; hegyi2009@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor of the First Surgical Department of the University of Semmelweis

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: April 19, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share