Endoscopic Ultrasonography Guided Biliary Drainage

Malignant Hepatobiliary Neoplasm Clinical Trial

Official title:

Endoscopic Ultrasonography-Guided Biliary Drainage Versus Percutaneous Trans-hepatic Biliary Drainage for Malignant Biliary Obstruction After Failed Endoscopic Retrograde Cholangio-pancreaticography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03195075
• Other study ID #: EUS
• Status: Not yet recruiting
• Phase: N/A
• First received: June 4, 2017
• Last updated: June 21, 2017
• Start date: January 2018
• Est. completion date: September 2020

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: Mohamed El-Yamany, MD
• Phone: 01002228914
• Email: elyamany72[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

If endoscopic retrograde cholangio-pancreaticography fails to achieve biliary drainage, more invasive options are usually considered. These include percutaneous trans-hepatic biliary drainage and surgical intervention but they have been associated with a higher risk of complications and prolonged hospital stay.

Some disadvantages with the percutaneous approach include the need to traverse the liver, a decreased quality of life due to the presence of external drainage and a significant morbidity and mortality, 7% and 5% respectively.

The external drainage of percutaneous trans-hepatic biliary drainage may add to the patient's burden owing to the cosmetic problem, skin inflammation or pain, or bile leakage, compromising the quality of life. From this point, the internal drainage of endoscopic ultrasonography-guided biliary drainage eliminates several issues.

Endoscopic ultrasonography-guided biliary drainage using a metal stent, particularly a lumen-apposing metal stent, can also be performed in patients with a large amount of ascites, which is often contraindicated in percutaneous trans-hepatic biliary drainage. Endoscopic ultrasonography-guided biliary drainage performed in the same session of the failed endoscopic retrograde cholangio-pancreaticography, in the same room and under the same sedation.

On the other hand, the endoscopic ultrasonography-guided biliary drainage, has major limitation due to fewer cases reported till date and lack of long term data. Because of, the technical difficulty encountered during re-intervention and problem of stent migration, the expertise needed for such procedure is a major limitation of the techniques.

Furthermore, comparative studies of endoscopic ultrasonography-guided biliary drainage versus percutaneous trans-hepatic biliary drainage are required to select the optimal candidates and to best evaluate the technical and treatment outcomes also in terms of quality of life and costs. Recently, Endoscopic ultrasonography-guided biliary drainage has been introduced as an alternative for patients who had failed endoscopic retrograde cholangio-pancreaticography.

Indications for endoscopic ultrasonography-guided biliary drainage:

1. Failed conventional endoscopic retrograde cholangio-pancreaticography.

2. Altered anatomy

3. Tumor preventing access into the biliary tree

4. Prior surgical procedure

5. Biliary sphincter stenosis

6. Contra-indication to percutaneous access

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Presence of un-resectable malignant distal biliary obstruction.

2. 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).

3. Histological or cytological diagnosis of malignancy

4. No serious or uncontrolled medical illness

Exclusion Criteria:

1. Patient age of less than 18 years

2. Uncorrectable coagulopathy

3. History of allergy to radio-contrast agents

4. Refusal to participate in this study

5. Severs co-existed cardiopulmonary and /or renal disease

6. Low platelet count (50000/µL)

7. Patients with disturbed conscious level

Related Conditions & MeSH terms

• Malignant Hepatobiliary Neoplasm

Intervention

Procedure:
• Endoscopic ultrasonography guided biliary drainage
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
• Percutaneous trans-hepatic biliary drainage
Percutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Collins D, Penman I, Mishra G, Draganov P. EUS-guided celiac block and neurolysis. Endoscopy. 2006 Sep;38(9):935-9. — View Citation

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. Review. — View Citation

Ferrucci JT Jr, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage: technique, results, and applications. Radiology. 1980 Apr;135(1):1-13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Püspök 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Evaluation of post-procedural complications	Evaluation of biliary leakage by ultrasound, hemorrhage by hemoglobin level, perforation and stent potency.	Within six months from procedure.