UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer
Title of the study (Brief title)	Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer
Region	Japan

Condition
Condition	Gastrointetinal fistulas
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the safety and efficacy of the endoscopic injection of an alpha-cyanoacrylate monomer for gastrointestinal fistulas.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of postprocedural complication
Key secondary outcomes	Incidence of fistulas closure Postoperative course Late complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Endoscopic injection of an alpha-cyanoacrylate monomer
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with intractable gastrointestinal fistulas 2) No severe disturbance of liver function and renal function 3) Written informed consent
Key exclusion criteria	1) Patients with esophagotracheal fistulas 2) Patients with bile duct fistulas 3) Patients with pancreatic duct fistulas 4) Doctor's decision not to register to this regimen
Target sample size	20

Research contact person
Name of lead principal investigator	Toshiyasu Ojima
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	tojima@wakayama-med.ac.jp

Public contact
Name of contact person	Toshiyasu Ojima
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	tojima@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	和歌山県立医科大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/30211297
Results
Other related information

Management information
Registered date	2015 Year 07 Month 30 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021403