UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000015532
Receipt number	R000018041
Scientific Title	Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms.
Date of disclosure of the study information	2014/10/26
Last modified on	2016/04/12 07:27:17

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Basic information

Public title

Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms.

Acronym

The efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection.

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Superficial esophageal neoplasms (either squamous cell carcinoma or basaloid carcinoma)

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

By applying "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" after esophageal endoscopic submucosal dissection, there is a high probability that the risk of post-ESD stricture as well as risks associated with "steroid injection" alone will be minimized. The objective of this study is to evaluate the efficacy and risks of combining these methods.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Number of endoscopic balloon dilation sessions required (within 12 weeks after ESD)

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

Purpose of intervention

Prevention

Type of intervention

Medicine Device,equipment Maneuver

Interventions/Control_1

Application of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" after esophageal ESD.

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) Superficial esophageal neoplasm (either squamous cell carcinoma or basaloid carcinoma) is pathologically diagnosed by endoscopic biopsy.
2) The neoplasm is located in the thoracic esophagus.
3) Lymph node metastasis is ruled out through CT examination.
4) The neoplasm meets either of the 2 following criteria:
1. a single neoplasm covering over half the circumference of the esophagus
2. multiple neoplasms that will require mucosal resection of over 3/4 the circumference of the esophagus
5) There will be only a single ESD defect.
6) The patient must be above 20 years of age.
7) The performance status of the patient must be 0-2.
8) The patient's dysphagia score must be 0.
9) Blood examination results must meet the following criteria:
1.Hb>=8.0g/dL
2.Plt>=100,000/mm3
3.AST,ALT<=150
4.Cre<=2.0mg/dL
10) Followup of the patient for 12 weeks after ESD must be possible.
11) Informed consent after sufficient explanation must be obtained.

Key exclusion criteria

1) The patient has received endoscopic treatment of the upper GI tract within 30 days of entry.
2) The patient is to receive endoscopic treatment of either the stomach or duodenum in the same session.
3) The patient has plans of receiving endoscopic treatment of the upper GI tract within 12 weeks.
4) The patient has allergy to either Lugol staining, polyglycolic acid, steroids, PPIs.
5) Possibility of pregnancy
6) Neuropsychiatric symptoms which may impair comprehension of the study.
7) A history of either angina or cardiac
infarction within 3 months
8) Uncontrolled hypertension
9) Others

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Satoshi Ono

Organization

The University of Tokyo Hospital

Division name

The Department of Gastroenterology

Zip code

Address

7-3-1 Hongou, Bunkyou-ku, Tokyo

TEL

03-3815-5411

Email

satono-tky@umin.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Yoshiki Sakaguchi

Organization

The University of Tokyo Hospital

Division name

The Department of Gastroenterology

Zip code

Address

7-3-1 Hongou, Bunkyou-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

sakaguchi-tky@umin.ac.jp

Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name

Funding Source

Organization

The University of Tokyo Hospital

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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 26 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

published doi:10.1038/ajg.2016.60

Between December 2014 and July 2015, 15 patients were enrolled. Each underwent per-protocol treatment with an ESD defect of over 3/4 the circumference of the esophagus. Four patients were excluded from analysis due to salvage esophagectomy. The remaining 11 patients (2 total circumferential, 9 semi-circumferential) were followed for 12 weeks.
Postoperative stricture occurred in 18.2% (2/11), with a median of 0 sessions of EBD required. Postoperative stricture was successfully prevented in one case of total circumferential resection. Of the semi-circumferential cases, postoperative stricture occurred in 11.1% (1/9), with a median of 0 EBD sessions.

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

2014 Year 10 Month 16 Day

Date of IRB

Anticipated trial start date

2014 Year 10 Month 29 Day

Last follow-up date

2015 Year 11 Month 18 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2015 Year 12 Month 01 Day

Other

Other related information

Management information

Registered date

2014 Year 10 Month 26 Day

Last modified on

2016 Year 04 Month 12 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018041

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name