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

NCT04898777 | Completed

• 1 other identifier: MD.21.03.437
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Biliary Obstruction

Keywords

ERCP; EUS; Distal Malignant Biliary Obstruction; Choledochoduodenostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of technical success

  During procedure

• Rate of clinical success

  4 weeks

• Procedural duration

  During procedure

• Reinterventions

  6 months

Study Arms (2)

ERCP-BD

ACTIVE COMPARATOR

ERCP Biliary Drainage by papillary approach with stent placement.

Procedure: Biliary drainage

EUS-BD

ACTIVE COMPARATOR

Endoscopic Ultrasound guided Biliary Drainage by Choledochoduodenostomy with transmural stent placement.

Procedure: Biliary drainage

Interventions

Biliary drainage PROCEDURE

Biliary decompression in cases of distal malignant obstruction by stent placement either using ERCP or EUS.

Also known as: Biliary Decompression

ERCP-BD; EUS-BD

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Specialized Medical Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

• Ahmed M Gaheen, MSc.

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Ahmed Y Altonbary, MD

  Mansoura University

  STUDY DIRECTOR

• Hazem H Alminshawy, Professor

  Mansoura University

  STUDY DIRECTOR

• Ahmed G Deiab, A.Professor

  Mansoura University

  STUDY DIRECTOR

• Magdy H Atwa, Professor

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 24, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)