Endoscopic Ultrasonography Guided Biliary Drainage

NCT03195075 | Unknown

• 1 other identifier: EUS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endoscopic ultrasonography is a widely accepted modality for the diagnosis of gastrointestinal and pancreatic-biliary diseases. Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative procedure to percutaneous trans-hepatic biliary drainage, with a technical success between 75%-100% and with low complication rate. Other important advantage of endoscopic ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic biliary drainage is better quality of life due to the internal placement of the stent.

Conditions

Malignant Hepatobiliary Neoplasm

Outcome Measures

Primary Outcomes (2)

• Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction.

  Evaluation of serum bilirubin and alkaline phosphatase by liver function test before and after the procedures

  Liver function test before the procedure and follow up changes after one week from procedures.

• Radiological evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction

  Evaluation of biliary dilation by abdominal ultrasonography before and after the procedures,

  Biliary dilation before the procedures and follow up changes after one week from procedures.

Secondary Outcomes (1)

• Evaluation of post-procedural complications

  Within six months from procedure.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage

Procedure: Endoscopic ultrasonography guided biliary drainage

Group 2

ACTIVE COMPARATOR

20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage.

Procedure: Percutaneous trans-hepatic biliary drainage

Interventions

Endoscopic ultrasonography guided biliary drainage PROCEDURE

Endoscopic ultrasonography guided biliary drainage includes rendezvous techniques, endoscopic ultrasonography guided choledochoduodenostomy, and endoscopic ultrasonography-guided hepatogastrostomy using self-expandable metal stent will be done for group 1

Group 1

Percutaneous trans-hepatic biliary drainage PROCEDURE

Percutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of un-resectable malignant distal biliary obstruction.
• Failed conventional endoscopic retrograde cholangio-pancreaticography and inaccessible papilla because of accompanying duodenal obstruction, peri-ampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation).
• Histological or cytological diagnosis of malignancy
• No serious or uncontrolled medical illness

You may not qualify if:

• Patient age of less than 18 years
• Uncorrectable coagulopathy
• History of allergy to radio-contrast agents
• Refusal to participate in this study
• Severs co-existed cardiopulmonary and /or renal disease
• Low platelet count (50000/μL)
• Patients with disturbed conscious level

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Ferrucci JT Jr, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology. 1980 Apr;135(1):1-13. doi: 10.1148/radiology.135.1.7360943.

  PMID: 7360943 BACKGROUND

• Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available.

  PMID: 1568614 BACKGROUND

• Hanada K, Iiboshi T, Ishii Y. Endoscopic ultrasound-guided choledochoduodenostomy for palliative biliary drainage in cases with inoperable pancreas head carcinoma. Dig Endosc. 2009 Jul;21 Suppl 1:S75-8. doi: 10.1111/j.1443-1661.2009.00855.x.

  PMID: 19691742 BACKGROUND

• Collins D, Penman I, Mishra G, Draganov P. EUS-guided celiac block and neurolysis. Endoscopy. 2006 Sep;38(9):935-9. doi: 10.1055/s-2006-944734.

  PMID: 16981114 BACKGROUND

• van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.

  PMID: 20071702 BACKGROUND

• Puspok A, Lomoschitz F, Dejaco C, Hejna M, Sautner T, Gangl A. Endoscopic ultrasound guided therapy of benign and malignant biliary obstruction: a case series. Am J Gastroenterol. 2005 Aug;100(8):1743-7. doi: 10.1111/j.1572-0241.2005.41806.x.

  PMID: 16086710 BACKGROUND

• Shami VM, Kahaleh M. Endoscopic ultrasonography (EUS)-guided access and therapy of pancreatico-biliary disorders: EUS-guided cholangio and pancreatic drainage. Gastrointest Endosc Clin N Am. 2007 Jul;17(3):581-93, vii-viii. doi: 10.1016/j.giec.2007.05.015.

  PMID: 17640584 BACKGROUND

• Fabbri C, Luigiano C, Lisotti A, Cennamo V, Virgilio C, Caletti G, Fusaroli P. Endoscopic ultrasound-guided treatments: are we getting evidence based--a systematic review. World J Gastroenterol. 2014 Jul 14;20(26):8424-48. doi: 10.3748/wjg.v20.i26.8424.

  PMID: 25024600 BACKGROUND

• Mallery S, Matlock J, Freeman ML. EUS-guided rendezvous drainage of obstructed biliary and pancreatic ducts: Report of 6 cases. Gastrointest Endosc. 2004 Jan;59(1):100-7. doi: 10.1016/s0016-5107(03)02300-9.

  PMID: 14722561 BACKGROUND

• Kim YS, Gupta K, Mallery S, Li R, Kinney T, Freeman ML. Endoscopic ultrasound rendezvous for bile duct access using a transduodenal approach: cumulative experience at a single center. A case series. Endoscopy. 2010 Jun;42(6):496-502. doi: 10.1055/s-0029-1244082. Epub 2010 Apr 23.

  PMID: 20419625 BACKGROUND

• Artifon EL, Ferreira FC, Otoch JP, Rasslan S, Itoi T, Perez-Miranda M. EUS-guided biliary drainage: a review article. JOP. 2012 Jan 10;13(1):7-17.

  PMID: 22233941 BACKGROUND

• Artifon EL, Okawa L, Takada J, Gupta K, Moura EG, Sakai P. EUS-guided choledochoantrostomy: an alternative for biliary drainage in unresectable pancreatic cancer with duodenal invasion. Gastrointest Endosc. 2011 Jun;73(6):1317-20. doi: 10.1016/j.gie.2010.10.041. Epub 2010 Dec 31. No abstract available.

  PMID: 21195404 BACKGROUND

• Burmester E, Niehaus J, Leineweber T, Huetteroth T. EUS-cholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc. 2003 Feb;57(2):246-51. doi: 10.1067/mge.2003.85.

  PMID: 12556796 BACKGROUND

Central Study Contacts

Mohamed El-Yamany, MD

CONTACT

01002228914; elyamany72@yahoo.com

wael Ahmed, MD

CONTACT

01064236064; drwaelabbas@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: This study will include 40 consecutive jaundiced patients with distal malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography. Twenty patients with failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography-guided biliary drainage will be performed by single endoscopist and another 20 patients with failed endoscopic retrograde cholangio-pancreaticography for percutaneous trans-hepatic biliary drainage.

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 22, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 22, 2017

Record last verified: 2017-06