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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008054
Receipt No. R000009439
Scientific Title Phase 2 study of biodegradable stents (BD-stent) for refractory benign esophageal strictures after curative treatment of esophageal cancer
Date of disclosure of the study information 2012/05/31
Last modified on 2015/07/10

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Basic information
Public title Phase 2 study of biodegradable stents (BD-stent) for refractory benign esophageal strictures after curative treatment of esophageal cancer
Acronym Phase 2 study of BD-stent
Scientific Title Phase 2 study of biodegradable stents (BD-stent) for refractory benign esophageal strictures after curative treatment of esophageal cancer
Scientific Title:Acronym Phase 2 study of BD-stent
Region
Japan

Condition
Condition refractory benign esophageal strictures after curative treatment of esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of BD stents for refractory benign esophageal strictures after curative treatment of esophageal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes proportion of dysphagia score improvement at 3-month
Key secondary outcomes Proportion of dysphagia score improvement at 6-month
Proportion of stricture improvement at 3-month
Proportion of stricture improvement at 6-month
Dysphagia free survival
Technical success rate of stent insertion
Stent migration rate
Adverse events

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
Device,equipment
Interventions/Control_1 BD 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 1)Esophageal cancer is considered as cured without relapse by radical resection, endoscopic therapy, radiotherapy, or chemoradiotherapy.
2)Benign esophageal stricture which meets all following criteria.
i)Dysphagia score of >= 2
ii)Endoscope (diameter of 9-11 mm) could not pass the stricture.
iii) Non-malignant finding with endoscopic examination.
iv) Non-malignant finding is proven with biopsy at the stricture.
3)Refractory esophageal stricture which meets one or both of the following criteria.
i)Number of balloon dilatations or bougies >= 5
and / or
ii)Number of Radial Incision and Cutting (RIC) >= 1
4)Stent insertion could conduct safely (i.e. meets any criterion as follows)
i)No esophageal fistula
ii)Distance from esophageal orifice to stricture is >= 3cm
iii)Length of stricture is <= 8cm
5)>= 20 years old.
6)ECOG performance status of <= 2.
7)Adequate organ function.
8)Written informed consent.
Key exclusion criteria 1)Delivery system (28F) could not pass the stricture even if any endoscopic dilation was conducted before BD stent insertion.
2)Systemic treatment is indicated for bacterial or fungal infection.
3)Synchronous other cancer except carcinoma in situ, intramucosal carcinoma or watchful waiting prostate cancer.
4)Radiation therapy within 6 months prior to enrollment.
5)Lugol-voiding lesion near the strictures or multiple Lugol-voiding lesion throughout the esophagus.
6)In opioid analgesics therapy.
7)Impossible to discontinue antithrombotic drug.
8)Severe dysphagia.
9)Women during pregnancy or breast-feeding.
10)In chronic treatment with steroids.
11)Patient is judged to be inappropriate for enrollment of the study for any reason by the investigator.
12)Prior treatment using BD stent placement
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Yano
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email toyano@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Yano
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email toyano@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center Research and Developing fund
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Piolax Medical Devices,Inc
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
京都大学医学部附属病院(京都府)
静岡県立静岡がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 31 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
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 Completed
Date of protocol fixation
2012 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2015 Year 07 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
2012 Year 05 Month 30 Day
Last modified on
2015 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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