UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of esophageal stenting for refractory benign esophageal stricture after esophageal cancer and gastric cancer surgery
Acronym	Efficacy of esophageal stenting for refractory benign esophageal stricture
Scientific Title	Efficacy of esophageal stenting for refractory benign esophageal stricture after esophageal cancer and gastric cancer surgery
Scientific Title:Acronym	Efficacy of esophageal stenting for refractory benign esophageal stricture
Region	Japan

Condition
Condition	refractory benign esophageal stricture
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of removable esophageal stent for refractory benign esophageal strictures after esophageal cancer and gastric cancer surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset rate of restenosis after esophageal stent removal
Key secondary outcomes	Proportion of dysphagia score improvement at 1-month after stent removal Proportion of stricture improvement at 5-month after stent removal Occurrence rate and the types of adverse events Periods to the onset of restenosis Occurrence rate of stent slippage

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	Device,equipment Maneuver
Interventions/Control_1	Esophageal stent placement Flexella-J esophageal stent
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	Patients with refractory benign esophageal stricture who underwent a history of dilatation procedure for benign esophageal stricture after esophageal cancer and gastric cancer surgery which meets one or both of the following criteria. 1) Dysphagia score of >= 2 2) Endoscope (diameter of 9-11 mm) could not pass the stricture. 3) Non-malignant finding with endoscopic examination. 4) ECOG performance status of 0-3. 5) >= 20 years old. 6) Patients with informed concent.
Key exclusion criteria	1) Patients with neoplastic lesions in the stenosis 2) Stenosis is in the high esophagus and the upper edge of the stent is assumed to contact with the esophageal entrance 3) Patients with a fistula in the stenosis 4) Stenosis length is more than 10cm 5) Patients with bleeding tendency 6) Patients who underwent radiation therapy 7) Women that there is a possibility of pregnancy or during pregnancy 8) Patient is judged to be inappropriate for enrollment of the study for any reason by the investigator
Target sample size	15

Research contact person
Last name of lead principal investigator	1st name Koichi Middle name Last name Okamoto
Organization	Kanazawa University, Graduate School of Medical Science
Division name	Division of Cancer Medicine
Zip code	920-8641
Address	13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL	0762652362
Email	okamoto.k@staff.kanazawa-u.ac.jp

Public contact
1st name of contact person	1st name Koichi Middle name Last name Okamoto
Organization	Kanazawa University, Graduate School of Medical Science
Division name	Division of Cancer Medicine
Zip code	920-8641
Address	13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL	0762652362
Homepage URL
Email	okamoto.k@staff.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University, Graduate School of Medical Science
Institute
Department

Funding Source
Organization	Kanazawa University, Graduate School of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kanazawa University, Graduate School of Medical Science
Address	13-1, Takaramachi, Kanazawa, Ishikawa, Japan
Tel	076-265-2362
Email	076-265-2362

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	2014 Year 11 Month 05 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000018131
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	4
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	2014 Year 11 Month 05 Day
Date of IRB	2014 Year 08 Month 25 Day
Anticipated trial start date	2014 Year 11 Month 05 Day
Last follow-up date	2018 Year 11 Month 29 Day
Date of closure to data entry	2018 Year 11 Month 29 Day
Date trial data considered complete	2018 Year 11 Month 29 Day
Date analysis concluded	2018 Year 11 Month 29 Day

Other
Other related information

Management information
Registered date	2014 Year 11 Month 04 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018131