Biliary Drainage in Patients With Duodenal Metal Stent

Jaundice Clinical Trial

Official title:

Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02376907
• Other study ID #: 10639
• Status: Active, not recruiting
• Phase: N/A
• First received: February 19, 2015
• Last updated: February 25, 2015
• Start date: January 2010
• Est. completion date: September 2017

Study information

• Verified date: February 2015
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.

Description:

This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2017
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.

• Patients who underwent endoscopic biliary drainage for nonresectable MBO.

• MBO was located = 2 cm from the bifurcation.

• Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.

• Age =20 years.

• Irrespective of sex and a primary disease.

Exclusion Criteria:

• Patients who underwent surgical bypass for GOO.

• Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.

• Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).

• Patients who would not give a consent to the report of their own data.

• Patients considered ineligible for inclusion in the study by an investigator for other reasons.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Jaundice
• Pyloric Stenosis

Intervention

Procedure:
• Biliary drainage
EUS-BD or ERCP

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Hospital, Second Military Medical University	Shanghai
Hong Kong	The Prince of Wales Hospital	Shatin
India	Asian Institute of Gastroenterology	Hyderabad
Japan	Fukushima Medical University	Fukushima
Japan	Gifu University	Gifu
Japan	Onomichi General Hospital	Hiroshima
Japan	Hokkaido University School of Medicine	Hokkaido
Japan	Sapporo Medical University	Hokkaido
Japan	Teine-Keijinkai Hospital	Hokkaido
Japan	Kinki University	Osaka
Japan	Saitama Medical University International Medical Center	Saitama
Japan	Graduate School of Medicine, The University of Tokyo	Tokyo
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	Kanto Central Hospital	Tokyo
Japan	Toho University Ohashi Medical Center	Tokyo
Japan	Tokyo Medical University	Tokyo
Japan	Tokyo Metropolitan Police Hospital	Tokyo
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Soon Chun Hyang University School of Medicine	Seoul
Malaysia	Prince Court Medical Center	Kuala Lumpur
Singapore	Singapore General Hospital	Outram Road
Singapore	Changi General Hospital	Simei
Taiwan	National Taiwan University Hospital	Taipei
Thailand	Chulalongkorn University	Bangkok
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo University

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Japan,  Korea, Republic of,  Malaysia,  Singapore,  Taiwan,  Thailand, 

References & Publications (9)

Hamada T, Nakai Y, Isayama H, Sasaki T, Kogure H, Kawakubo K, Sasahira N, Yamamoto N, Togawa O, Mizuno S, Ito Y, Hirano K, Toda N, Tada M, Koike K. Duodenal metal stent placement is a risk factor for biliary metal stent dysfunction: an analysis using a time-dependent covariate. Surg Endosc. 2013 Apr;27(4):1243-8. doi: 10.1007/s00464-012-2585-9. Epub 2012 Oct 17. — View Citation

Horaguchi J, Fujita N, Noda Y, Kobayashi G, Ito K, Obana T, Takasawa O, Koshita S, Kanno Y. Endosonography-guided biliary drainage in cases with difficult transpapillary endoscopic biliary drainage. Dig Endosc. 2009 Oct;21(4):239-44. doi: 10.1111/j.1443-1661.2009.00899.x. — View Citation

Itoi T, Isayama H, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Tsuji S, Ishii K, Ikeuchi N, Tanaka R, Umeda J, Moriyasu F, Kawakami H. Stent selection and tips on placement technique of EUS-guided biliary drainage: transduodenal and transgastric stenting. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):664-72. doi: 10.1007/s00534-011-0410-9. Review. — View Citation

Kahaleh M, Hernandez AJ, Tokar J, Adams RB, Shami VM, Yeaton P. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc. 2006 Jul;64(1):52-9. — View Citation

Kaw M, Singh S, Gagneja H. Clinical outcome of simultaneous self-expandable metal stents for palliation of malignant biliary and duodenal obstruction. Surg Endosc. 2003 Mar;17(3):457-61. Epub 2002 Oct 31. — View Citation

Kawakubo K, Isayama H, Nakai Y, Sasahira N, Kogure H, Sasaki T, Hirano K, Tada M, Koike K. Simultaneous Duodenal Metal Stent Placement and EUS-Guided Choledochoduodenostomy for Unresectable Pancreatic Cancer. Gut Liver. 2012 Jul;6(3):399-402. doi: 10.5009/gnl.2012.6.3.399. Epub 2012 Jul 12. — View Citation

Maire F, Hammel P, Ponsot P, Aubert A, O'Toole D, Hentic O, Levy P, Ruszniewski P. Long-term outcome of biliary and duodenal stents in palliative treatment of patients with unresectable adenocarcinoma of the head of pancreas. Am J Gastroenterol. 2006 Apr;101(4):735-42. — View Citation

Moon JH, Choi HJ. Endoscopic double-metallic stenting for malignant biliary and duodenal obstructions. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):658-63. doi: 10.1007/s00534-011-0409-2. Review. — View Citation

Mutignani M, Tringali A, Shah SG, Perri V, Familiari P, Iacopini F, Spada C, Costamagna G. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy. 2007 May;39(5):440-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrent biliary obstruction	Recurrent biliary obstruction is defined as a composite endpoint of either occlusion or migration of biliary stent, and time to recurrent biliary obstruction is time from biliary drainage to recurrence of biliary obstruction.	Up to 1 year	No
Secondary	Causes of recurrent biliary obstruction	Causes of recurrent biliary obstruction include sludge, food impaction, ingrowth, tumor overgrowth, hemobilia and others.	Up to 1 year	No
Secondary	Functional success rate of biliary drainage	Functional success is defined when bilirubin decreases < 50% or is normalized within 2 weeks.	2 weeks	No
Secondary	Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)	Complications and their severity are determined using the American Society of Gastrointestinal Endoscopy guidelines.	30 days	No
Secondary	Survival time	Survival time is defined as the period between biliary stent placement and death.	Up to 2 year	No

External Links

•   Tokyo Conference of Asian Pancreato-biliary Interventional Endoscopist