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

Malignant Biliary Obstruction Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

• NCT number: NCT04898777
• Study type: Interventional
• Source: Mansoura University
• Contact: Ahmed M Gaheen, MSc.
• Phone: +201220755170
• Email: gaheen@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Completion date: July 1, 2024