Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer
Primary Purpose
Pancreatic Head Cancer, Obstructive Jaundice
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pancreaticoduodenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Head Cancer
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
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ERCP group
PTD group
Arm Description
endoscopic retrograde cholangiopancreaticography with plastic stent insertion
ultrasound guided percutaneous transhepatic catheter insertion
Outcomes
Primary Outcome Measures
number of participants with operative difficulties as assessed by the operating surgeon
measuring the difficulty of dissection, number of operative complications encountered
number of participants with post operative complications
detection of postoperative complications in the early postoperative period
Secondary Outcome Measures
number of participants with postprocedural complications
detection of postprocedure complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04823832
Brief Title
Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer
Official Title
Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer With Hyperbilirubinemia and Impact on Pancreaticoduodenectomy: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hani Alhadad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Head Cancer, Obstructive Jaundice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERCP group
Arm Type
Active Comparator
Arm Description
endoscopic retrograde cholangiopancreaticography with plastic stent insertion
Arm Title
PTD group
Arm Type
Active Comparator
Arm Description
ultrasound guided percutaneous transhepatic catheter insertion
Intervention Type
Procedure
Intervention Name(s)
pancreaticoduodenectomy
Other Intervention Name(s)
whipple operation
Intervention Description
resection of the head of pancreas and the duodenum followed by triple anastomosis
Primary Outcome Measure Information:
Title
number of participants with operative difficulties as assessed by the operating surgeon
Description
measuring the difficulty of dissection, number of operative complications encountered
Time Frame
up to 6 hours at the time of surgery
Title
number of participants with post operative complications
Description
detection of postoperative complications in the early postoperative period
Time Frame
up to one month
Secondary Outcome Measure Information:
Title
number of participants with postprocedural complications
Description
detection of postprocedure complications
Time Frame
up to one month after each procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael N Abdelsalam, doctor
Organizational Affiliation
dean of faculty
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
to keep the confidentiality of each patient
Learn more about this trial
Endoscopic Versus Percutaneous Biliary Drainage for Resectable Pancreatic Head Cancer
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