UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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.
Region	Japan

Condition
Condition	Superficial esophageal neoplasms (either squamous cell carcinoma or basaloid carcinoma)
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	15

Research contact person
Name of lead principal investigator	Satoshi Ono
Organization	The University of Tokyo Hospital
Division name	The Department of Gastroenterology
Address	7-3-1 Hongou, Bunkyou-ku, Tokyo
TEL	03-3815-5411
Email	satono-tky@umin.ac.jp

Public contact
Name of contact person	Yoshiki Sakaguchi
Organization	The University of Tokyo Hospital
Division name	The Department of Gastroenterology
Address	7-3-1 Hongou, Bunkyou-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	sakaguchi-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000018041