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Preoperative Biliary Drainage in Malignant Biliary Obstruction

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pecs

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years

OJ of malignant origin (pancreatic head or periampullary tumor)

Total bilirubin level ≥ 40 μmol per liter

Signed written informed consent

Disqualifiers

Proved metastasis

Irresectable tumor

Neo-adjuvant chemotherapy

Co-existing malignancy

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Preoperative drainage and pancreatoduodenectomy

    Procedure/Surgery

    Preoperative biliary drainage before surgical removal of the tumor

  • Pancreatoduodenectomy

    Procedure/Surgery

    Pancreatic tumor resection without previous preoperative biliary drainage

Treatment groups

353 Participants
are divided into 2 treatment groups
Group A: Preoperative biliary drainage and pancreatoduodenectomy1 intervention
Group B: Pancreatoduodenectomy only1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
120 days
2

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

Time frame
120 days

Secondary outcomes

1

Length of hospitalization

Length of hospitalization after biliary drainage and surgery

Time frame
120 days
2

Mortality

Rate of mortality among groups

Time frame
30 days
3

Mortality

Rate of mortality among the groups

Time frame
120 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pecs

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: