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NCT Number: NCT06613945

ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura univeristy

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location status: Recruiting

Location contact

Ahmed Y Altonbary, Assprofessor

CONTACT

[email protected]

+20 100 5100091 ext. +2

Ahmed Y Altonbary, Assprofessor

SUB_INVESTIGATOR

Mennatallah E Saad, Asslecturer

CONTACT

[email protected]

+20 122 2449220 ext. +2

Mennatallah E Saad, Asslecturer

PRINCIPAL_INVESTIGATOR

About this study

Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO.

The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS.

technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III & IV only.
  • Histologically confirmed malignant hilar biliary obstruction.
  • Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
  • Absence of duodenal narrowing/obstruction.
  • Accept sharing in the study

Exclusion criteria

  • Pregnancy.
  • Distal biliary obstruction as the main lesion.
  • Benign biliary stenosis.
  • Malignant hilar biliary obstruction bismuth type I and II.
  • Presence of duodenal obstruction.
  • Surgically altered anatomy or inability to access the major duodenal papilla.
  • Patients underwent previous intervention for biliary drainage.
  • Previously failed biliary cannulation at ERCP.
  • Large volume ascites.
  • Patients unfit for anesthesia.
  • Patients having uncorrectable coagulopathy or thrombocytopenia.
  • History of allergy to radiocontrast agents.
  • Refuse sharing in the study.

Treatment and study plan

ERCP biliary drainage

Procedure

bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage

Combined ERCP and EUS-HGS biliary drainage

Procedure

unilateral metallic stent will be inserted on right side by ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage.

Primary outcomes

  1. Technical success

    Time frame: during the procedure

    considered after stent placement (expanded and patent) with good bile flow and drainage

  2. Procedural duration

    Time frame: at the end of the procedure

    defined as time from biliary cannulation to stent placement by ERCP, and time from needle puncture of the dilated bile duct to stent placement by EUS

  3. Clinical success

    Time frame: 3 month

    considered at 2 weeks by a 50% decrease in total bilirubin levels from baseline and at 4 weeks if total bilirubin is less than 3mg/dL.

  4. Re-interventions

    Time frame: 3 month

    need for re-intervention to secure biliary drainage

Secondary outcomes

  1. Adverse events

    Time frame: 3 month

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Y Altonbary, Assprofessor

CONTACT

[email protected]

0502200590 ext. 0502200590

Mennatallah E Saad, Asslecturer

CONTACT

[email protected]

0502200590 ext. 0502200590

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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