UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015605
Receipt number R000018131
Scientific Title Efficacy of esophageal stenting for refractory benign esophageal stricture after esophageal cancer and gastric cancer surgery
Date of disclosure of the study information 2014/11/05
Last modified on 2019/05/20 23:02:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

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 or person

Institute

Kanazawa University, Graduate School of Medical Science

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018131


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name