UMIN-CTR Clinical Trial

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

refractory benign esophageal strictures after curative treatment of esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Organization

National Cancer Center Research and Developing fund

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Piolax Medical Devices,Inc

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

05

Month

30

Day

Last modified on

2015

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009439