UMIN-CTR Clinical Trial

Basic information
Public title	Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy
Acronym	ENEC study
Scientific Title	Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy
Scientific Title:Acronym	ENEC study
Region	Japan

Condition
Condition	early esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Recently, diagnostic technology of gastrointestinal endoscopy, using image enhancement such as magnifying endoscopy, has developed. Accuracy of endoscopic diagnosis for early esophageal squamous cell carcinoma (ESCC) is reported as about 90%. Because endoscopic biopsy sometime causes scar and fibrosis which would make endoscopic resection difficult and because histological diagnosis of minute specimens obtained by biopsy is not always accurate, endoscopic resection for ESCC is now often performed without preoperative endoscopic biopsy in Japan. Accurate technology of endoscopic diagnosis is therefore required. Recently, high-resolution and ultra-high magnifying (about 500x) videoendoscopy, known as endocytoscopy, that enables microscopic observation at the cellular level has been developed. However, diagnostic ability of endocytoscopy for early esophageal tumor (without biopsy) has not been reported. In this study, we will perform endoscopic surveillance for the patients with high risk of ESCC by using endocytoscopy. The aim of this study is to confirm the accuracy of optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity of endoscopic diagnosis by using endocytoscopy.
Key secondary outcomes	1) Rate of evaluable ultra-high magnifying images. 2) Specificity of endoscopic diagnosis by using endocytoscopy. 3) Accuracy of endoscopic diagnosis by using endocytoscopy.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The study subjects included patients who underwent ER for ESCC or were treated for head and neck cancer at the Hokkaido University Hospital and Keiyukai daini hospital, or were refered to the 2 hospitals for the lesions suspicious for early ESCC. The inclusion criteria of this study were as follows: 1) who have background mucosa with multiple minute iodine unstained areas (high risk group for metachronous ESCC), and 2) written informed consent obtained from the patient.
Key exclusion criteria	Exclusion criteria were as follows: 1) with histological diagnosis of SCC by prior endoscopic biopsy, 2) unsuitability as subjects, 3) age < 20 years, and 4) current pregnancy.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Shimizu
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Zip code	060-8648
Address	Kita 14 jo, Nishi 5 chome, Kitaku, Sapporo, Japan
TEL	011-716-1161
Email	yshimizu@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Inoue
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology
Zip code	060-8648
Address	Kita 14 jo, Nishi 5 chome, Kitaku, Sapporo, Japan
TEL	011-716-1161
Homepage URL
Email	mokomokomomon@gmail.com

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Hokkaido University Hospital Institutional Review Board
Address	Kita 14 jo, Nishi 5 chome, Kitaku, Sapporo, Japan
Tel	011-706-7924
Email	crjimu@huhp.hokudai.ac.jp

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	2019 Year 07 Month 25 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	Enrolling by invitation
Date of protocol fixation	2019 Year 05 Month 01 Day
Date of IRB	2019 Year 06 Month 04 Day
Anticipated trial start date	2019 Year 06 Month 20 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Patients who are included in this study undergo endoscopic surveillance by using endocytoscopy. If esophageal lesions suspicious for early squamous cell carcinoma (redness area in white light, brownish area in narrow band imaging or demarcated unstained area in iodin staining) are found, endoscopists immediately perform ultra-high magnifying observation (with dyeing of 1% methylene blue solution and 0.05% crystal violet solution) for the lesion. Patients who are diagnosed to have ESCC by using endocytoscopy will undergo endoscopic resection later. Patients who are diagnosed to have benign lesion by using endocytoscopy undergo ordinal endoscopic biopsy. All procedure will be performed by endoscopists who are examined for diagnosis of early ESCC. Final histological diagnosis will be decided in Sapporo Kosei Hospital as the central review. All specimens will be diagnosed to squamous cell carcinoma (including high grade intraepithelial neoplasia), low grade dysplasia and non-tumor (inflammation, epithelial atrophy) according to WHO classification.

Management information
Registered date	2019 Year 07 Month 15 Day
Last modified on	2019 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042614

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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