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

  • STATUS
    Recruiting
  • days left to enroll
    36
  • participants needed
    50
  • sponsor
    Mansoura University
Updated on 26 September 2021

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.

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.

Details
Condition Malignant Biliary Obstruction
Treatment Biliary drainage
Clinical Study IdentifierNCT04898777
SponsorMansoura University
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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