UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcome of combined metallic stent placement in malignant biliary and duodenal obstruction
Title of the study (Brief title)	Clinical outcome of double stenting
Region	Japan

Condition
Condition	Malignant biliary and duodenal obstruction
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with double stenting (DS).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the clinical outcomes related to biliary and duodenal self-expandable metal stents (SEMS) in patients with DS.
Key secondary outcomes	Compared the adverse events and patency of biliary and duodenal SEMS using duodenal Uncovered SEMS and Covered SEMS.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Malignant bilioduodenal obstruction patients, who consent to participate in the study in Nagoya City University Hospital and research cooperation facilities
Key exclusion criteria	Not obtained the consent
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuki Hori
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL	+81-52-853-8211
Email	yhori@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Itaru Naitoh
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL	+81-52-853-8211
Homepage URL
Email	inaito@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya Daini Red cross Hospital, Gifu Prefectural Tajimi Hospital, Kasugai Municipal Hospital, Nagoya City West Medical Center Toyokawa City Hospital Japan Community Health Care Organization Gamagori City Hospital
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋第二赤十字病院（愛知県）、岐阜県立多治見病院（岐阜県）、春日井市民病院（愛知県）、名古屋市西部医療センター（愛知県）、豊川市民病院（愛知県）、中京病院（愛知県）、蒲郡市民病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 01 Month 01 Day
Anticipated trial start date	2004 Year 01 Month 01 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 06 Month 02 Day
Date trial data considered complete	2017 Year 06 Month 02 Day
Date analysis concluded	2017 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28902972
Results	BACKGROUND: Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS. METHODS: Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]). RESULTS: A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (p = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent (C-SEMS) group than in the U-SEMS group (p = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (p = 0.724). CONCLUSIONS: Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. C-SEMS is the preferred type of duodenal SEMS in patients with DS.
Other related information	Samples are collected from subjects who participated in this study in Nagoya City University Hospital and research affiliated facilities. Samples and clinical information without containing personal information are numbered and managed in Nagoya City University Hospital. Consecutive paitents who underwent metallic stenting for malignant bilioduodenal obstruction in affiliated institutions from 2004.

Management information
Registered date	2017 Year 06 Month 02 Day
Last modified on	2017 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031192