Skip to main content
OpenTrials
Completed

NCT Number: NCT04289831

Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periampullary Cancer Biliary Obstruction Preoperative Biliary Drainage

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed by direct surgery while group II managed by PBD followed by surgery. Both groups were compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years survival rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Serum bilirubin level above 4 mg/dl
  • suspected peri-ampullary tumor at computed tomography (CT)
  • No evidence of distant metastasis or locally advanced tumor

Exclusion criteria

  • Patients with evidence of distant metastasis or locally advanced tumor
  • Prior neoadjuvant chemotherapy or Radiotherapy
  • Prior biliary surgery
  • Patients with contraindication for major surgery

Treatment and study plan

Preoperative Biliary Drainage (PBD)

Procedure

Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines

Surgery

Procedure

The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy

Primary outcomes

  1. Early postoperative mortality (within 3 months)

    Time frame: within 90 days after surgery

    Death within 90 days postoperatively

  2. Early postoperative morbidities (within 3 months)

    Time frame: within 90 days after surgery

    Any complications related to surgery within 3 months including: postoperative bleeding, pancreatic fistula, Biliary leakage, Intra-abdominal infection, wound infection/ dehiscence

Secondary outcomes

  1. Tumor recurrence

    Time frame: 2 years follow up after surgery

    Local or systemic recurrence of the malignant tumor

  2. Disease free survival (DFS)

    Time frame: 2 years follow up after surgery

    % of patients survived without any evidence of tumor recurrence after 2 years follow up

  3. Overall survival (OS)

    Time frame: 2 years follow up after surgery

    % of patients survived with or without tumor recurrence after 2 years follow up

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

"Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Feb 28, 2020
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.