Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer

NCT04823832 | Completed

• 1 other identifier: 30/11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with potentially resectable pancreatic head cancer and high bilirubin level, were stratified into two equal groups according to the method of biliary drainage: endoscopic stenting or percutaneous drainage.

Conditions

Pancreatic Head Cancer; Obstructive Jaundice

Outcome Measures

Primary Outcomes (2)

• number of participants with operative difficulties as assessed by the operating surgeon

  measuring the difficulty of dissection, number of operative complications encountered

  up to 6 hours at the time of surgery

• number of participants with post operative complications

  detection of postoperative complications in the early postoperative period

  up to one month

Secondary Outcomes (1)

• number of participants with postprocedural complications

  up to one month after each procedure

Study Arms (2)

ERCP group

ACTIVE COMPARATOR

endoscopic retrograde cholangiopancreaticography with plastic stent insertion

Procedure: pancreaticoduodenectomy

PTD group

ACTIVE COMPARATOR

ultrasound guided percutaneous transhepatic catheter insertion

Procedure: pancreaticoduodenectomy

Interventions

pancreaticoduodenectomy PROCEDURE

resection of the head of pancreas and the duodenum followed by triple anastomosis

Also known as: whipple operation

ERCP group; PTD group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with malignant obstruction of the distal common bile duct e.g. adenocarcinoma of the pancreatic head or periampullary tumor
• Hyperbilirubinemia, total bilirubin level more than 10 mg/dL
• Cholangitis, pruritis, coagulopathy, nausea and anorexia

You may not qualify if:

• Patients with advanced disease
• metastatic disease
• Patients undergoing neoadjuvant therapy

Sponsors & Collaborators

• Hani Alhadad: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Jaundice, Obstructive

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wael N Abdelsalam, doctor

  dean of faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: April 1, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)