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Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

NCT03358095 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-20

No results posted yet for this study

Summary

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

Conditions

Interventions

DEVICE

Tannenbaum Fr 10 stent or WallFlex stent

A plastic or metallic endoprosthesis is placed to the biliary ducts.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Sini Vehviläinen, MD · Helsinki University Central Hospital

  • Hanna Seppänen, MD, PhD · Helsinki University Central Hospital

  • Arto Kokkola, MD, PhD · Helsinki University Central Hospital

  • Marianne Udd, MD, PhD · Helsinki University Central Hospital

  • Outi Lindström, MD, PhD · Helsinki University Central Hospital

  • Johanna Louhimo, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-26
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03358095 on ClinicalTrials.gov