Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer

NCT ID: NCT04823832

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

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.

Detailed Description

Along with history taking and complete clinical examination, the results of complete blood count, international normalized ratio , renal and liver function tests were obtained. Patients with coagulopathy were corrected by fresh frozen plasma and repeated vitamin K injections to reach an INR of at least 1.4 before the intervention, otherwise, they were excluded. Besides, ultrasound and computed tomography of the abdomen/pelvis (pancreatic protocol) were routinely undertaken. Tumors were staged for resectability according to TNM staging system.

Patients were randomly divided by closed envelope method into two groups; patients were allocated to the first group (ERCP) who underwent Endoscopic Retrograde Cholangio-Pancreatography coupled with placement of a 10-French plastic stent; and to the second group (PTD) who underwent Fluoroscopy-guided Percutaneous Transhepatic Drainage.

Preoperative biliary drainage Parenteral broad spectrum antibiotics were administered prior and after each intervention. ERCP was performed under general anesthesia in the operation room and a 10-french (3.2 mm) covered polyethylene stent with side flaps to prevent migration was placed below the level of biliary bifurcation. Stents were inserted over a guidewire via an Olympus 4.2 mm channel endoscope, by standard techniques.

PTD was placed in the interventional radiology department under local anesthesia via the left duct sub-xiphoid approach, only via the external approach. A 6 french gauge catheter was positioned with its tip above the biliary obstruction. After PTD, patients were instructed to drink a lot of fluids to replace fluid loss or they were given temporary intravenous fluid supplementation.

After either procedure, patients were either discharged home or kept in hospital. Those who were discharged were readmitted for preoperative preparation. Patients were followed up clinically as well as by laboratory results. The total and direct bilirubin level and other liver function tests were repeated after ten days from the procedure to estimate the decline in their levels. Post-intervention complications either PTD-related such as bleeding, cholangitis, bile leak and catheter occlusion/displacement; or ERCP-related such as pancreatitis, cholangitis, bleeding and stent displacement; were recorded.

Surgery After improvement of liver functions, patients were scheduled for PD. All operations were performed through a hockey-stick incision by consultant surgeons experienced in pancreatic surgery. The standard surgical procedure was pancreaticoduodenectomy with pylorus preservation. The effects of pre-operative drainage were evaluated during the operation in terms of operative resection time, blood loss, difficulties of dissection and intra-operative bleeding. While the endoscopic stent is removed intra-operatively after transection of the common hepatic duct, the catheter of PTD is left and inserted in the hepaticojejunostomy (stented anastomosis) to be removed two weeks later. Perioperative complications (< 30 days) were stratified for each group according to Clavien-Dindo classification.

Conditions

Pancreatic Head Cancer; Obstructive Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERCP group

endoscopic retrograde cholangiopancreaticography with plastic stent insertion

Group Type: ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

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

PTD group

ultrasound guided percutaneous transhepatic catheter insertion

Group Type: ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

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

Interventions

pancreaticoduodenectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

whipple operation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hani Alhadad

OTHER

Sponsor Role: lead

Responsible Party

Hani Alhadad

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wael N Abdelsalam, doctor

Role: STUDY_DIRECTOR

dean of faculty

Locations

Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

30/11

Identifier Type: -

Identifier Source: org_study_id