EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction

Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus Endoscopic Retrograde Cholangiopancreatography for Primary Biliary Decompression in Distal Malignant Biliary Obstruction

Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes.

Pancreatobiliary cancers generally present with jaundice, weight loss, and anorexia with significant impact on quality of life, morbidity, and mortality.

The primary goal of diagnosis and management is curative resection but it's difficult due to local invasion and distant metastases at the time of clinical presentation. Biliary decompression helps to reduce symptoms and improve quality of life in patients with malignant biliary obstruction.

Endoscopically placed stents have become the standard of care for non-surgical biliary drainage due to their minimal invasiveness compared to percutaneous drainage.

The standard treatment of obstructive jaundice has been ERCP with biliary stent placement with high success rate in expert hands and low frequency of adverse events.

Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly used in patients who underwent failed ERCP. EUS-BD can be performed in several ways, choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), antegrade (AG) procedure, and rendezvous (RV) technique.

Study Overview

• Status: Recruiting
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Procedure: Biliary drainage

Detailed Description

This study will be a single center, prospective randomized comparative study that includes 50 patients with distal malignant biliary obstruction including pancreatic head masses, distal cholangiocarcinoma or papillary carcinoma.

All patients with inclusion criteria will be recruited in the study by simple random sampling using sealed envelopes until fulfillment of needed sample size for both EUS-BD arm and ERCP-BD arm.

Study tools:

• Informed consent will be obtained from each participant sharing in the study.
• Throughout history taking, complete general examination and local abdominal examination.
• Laboratory investigations: CBC, Serum creatinine, Liver functions tests (AST, ALT and Serum Albumin), Alkaline phosphatase, Serum bilirubin and INR.
• ERCP-BD by papillary approach and EUS-BD by choledochoduodenostomy with transmural stent placement.
• All procedures will be performed under deep sedation or general anesthesia in the left lateral position.
• Procedural time is recorded.
• Technical success is considered after stent placement (expanded and patent) with good bile flow and drainage.
• Follow up:
• Lab investigations will be requested at 2 days, 2 and 4 weeks, 3 and 6 months after the procedure including:

CBC, S.Cr, S.Bil, AST, ALT, S.Alb, ALP and INR.

- Early adverse events (within 48 hours after procedure) including: Pancreatitis, Cholangitis, Bleeding, Perforation and Peritonitis.

• Late adverse events include stent dysfunction either due to food impaction, tumor ingrowth or stent migration.
• Clinical success is considered at 2 weeks if total bilirubin is less than 50% of baseline and at 4 weeks if total bilirubin is less than 3mg/dL.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Gaheen, MSc.; Phone Number: +201220755170; Email: gaheen@gmail.com
• Study Contact Backup: Name: Ahmed Y Altonbary, MD; Phone Number: +201005100091; Email: Altonbary@gmail.com

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Recruiting
      • Specialized Medical Hospital
      • Sub-Investigator: Ahmed Y Altonbary, MD
      • Contact: Ahmed M Gaheen, MSc.; Phone Number: +201220755170; Email: gaheen@gmail.com
      • Principal Investigator: Ahmed M Gaheen, MSc.
      • Sub-Investigator: Hazem H Alminshawy, Professor
      • Sub-Investigator: Ahmed G Deiab, A.Professor
      • Sub-Investigator: Magdy H Atwa, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18 years and older.
• Presence of locally advanced or metastatic pancreatic head mass on CT or magnetic resonance imaging of the abdomen
• Absence of duodenal obstruction.
• Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
• Histologic or cytologic diagnosis of malignancy.
• Accept sharing in the study.

Exclusion Criteria:

• Age younger than 18 years.
• Pregnancy.
• Hilar biliary obstruction (as the main lesion or coexisting with distal obstruction).
• Presence of duodenal obstruction.
• Histologic or cytologic diagnosis of malignancy.
• Patients underwent previous intervention for biliary drainage.
• Previously failed biliary cannulation at ERCP.
• Prior biliary sphincterotomy or stent placement.
• Surgically altered anatomy or inability to access the major duodenal papilla.
• Patients unfit for anesthesia.
• Patients having uncorrectable coagulopathy or thrombocytopenia.
• History of allergy to radiocontrast agents.
• Refuse sharing in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERCP-BD; ERCP Biliary Drainage by papillary approach with stent placement.	Procedure: Biliary drainage; Biliary decompression in cases of distal malignant obstruction by stent placement either using ERCP or EUS.; Other Names: Biliary Decompression
Active Comparator: EUS-BD; Endoscopic Ultrasound guided Biliary Drainage by Choledochoduodenostomy with transmural stent placement.	Procedure: Biliary drainage; Biliary decompression in cases of distal malignant obstruction by stent placement either using ERCP or EUS.; Other Names: Biliary Decompression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of adverse events	- Early adverse events (within 48 hours after procedure) including: Pancreatitis, Cholangitis, Bleeding, Perforation and Peritonitis. - Late adverse events include stent dysfunction either due to food impaction, tumor ingrowth or stent migration	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of technical success	Technical success is considered after successful stent placement.	During procedure
Rate of clinical success	Clinical success is considered at 2 weeks if total bilirubin is less than 50 percent of baseline.	4 weeks
Procedural duration	Procedure time was defined as time from biliary cannulation to stent placement in ERCP group, and time from needle puncture of the dilated bile duct to stent placement in EUS-BD group. In cases of difficult cannulation (defined as failed biliary access within 5 min of attempt), we performed early precut fistulotomy for cannulation by experts without involvement of trainees and duodenal intubation time was not included within procedure time.	During procedure
Reinterventions	Re-endoscopy in cases of stent migration, occlusion by food or tumor ingrowth.	6 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Ahmed Y Altonbary, MD, Mansoura University; Principal Investigator: Ahmed M Gaheen, MSc., Mansoura University; Study Director: Hazem H Alminshawy, Professor, Mansoura University; Study Director: Ahmed G Deiab, A.Professor, Mansoura University; Study Chair: Magdy H Atwa, Professor, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ERCP; EUS; Distal Malignant Biliary Obstruction; Choledochoduodenostomy
• Other Study ID Numbers: MD.21.03.437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No