UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness and safety of clip-assisted endoscopic linear incision for intractable benign gastrointestinal stenosis
Acronym	Endoscopic linear incision for intractable gastrointestinal stenosis
Scientific Title	Elimination of intractable gastrointestinal stricture
Scientific Title:Acronym	Stenosis release
Region	Japan

Condition
Condition	Refractory benign gastrointestinal stenosis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The common treatment for benign esophageal stenosis after surgery and endoscopic treatment is endoscopic ballon dilatation (EBD), but effective treatment for EBD resistance and intractable cases has been not established. Therefore, we devised a new stenosis release and clip-assisted endoscopic linear incision for intractable benign gastrointestinal stenosis, and examine its usefulness and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stenosis release rate [% of patients with improvement of dysphagia (up to Dysphagia score 1 or less), a subjective symptom at 24 weeks after the start of treatment (%): number of improved patients / total number of patients x100]
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Clip-assisted endoscopic linear incision
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) more than 20 years old 2) Those who have agreed in writing to participate in this clinical study 3) Patients who have no residual cancer (R0) for benign esophageal stenosis after surgery and endoscopic treatment (Confirmation has also been performed on CT, etc.) 4) Any post-operative reconstruction site and method 5) Dysphagia (Dysphagia score> 2) despite two or more sets of EBD (one set undergoes EBD more than once) with EBD as a pre-treatment for esophageal stenosis at least 1 month apart Patient with chief complaint. * Regardless of chemotherapy, PSL oral history
Key exclusion criteria	1) Unable to obtain consent 2) When the length of the stenosis exceeds 11 mm or the preventive clip cannot be placed 3) Patients with mental illness or psychiatric symptoms who are judged to be difficult to conduct this clinical trial 4) Long axis stenosis length of 2 mm or more (confirmed by endoscopy and X-ray contrast) 5) Others who the doctor judged inappropriate
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Kobara
Organization	Faculty of Medicine, Kagawa University
Division name	Gastroenterology and Neurology
Zip code	761-0793
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	0878912156
Email	kobara@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Planning Investigator Middle name Last name General Affairs Division
Organization	Faculty of Medicine, Kagawa University Hospital
Division name	Investigator
Zip code	761-0793
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	0878985111
Homepage URL
Email	chosa@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Kagawa University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Faculty of Medicine, Kagawa University
Address	1750-1 Ikenobe, Miki, Kita
Tel	0878985111
Email	chosa@med.kagawa-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 09 Month 25 Day
Date of IRB	2019 Year 11 Month 21 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2022 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 18 Day
Last modified on	2022 Year 09 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045458