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

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.

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.