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A multicenter prospective randomized controlled trial of the usefulness of RDI for injection in esophageal ESD

A multicenter prospective randomized controlled trial of the usefulness of RDI for injection in esophageal ESD - Esophageal RDI study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047475
Enrollment
130
Registered
2022-04-14
Start date
2022-04-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

superficial esophageal cancer

Interventions

During mucosal injection in esophageal ESD, use RDI to identify the presence of blood vessels and avoid them during injection. During mucosal injection in esophageal ESD, white light alone is used for

Sponsors

Keio University
Lead Sponsor
1. National Hospital Organization Tokyo Medical Center 2. Saitama City Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients over 20 years old who will undergo ESD for lesions diagnosed or suspected to be superficial esophageal cancer at Keio University Hospital and collaborating hospitals. We don't necessarily need a tissue diagnosis.

Exclusion criteria

Exclusion criteria: (1) Cases in which antithrombotic drug withdrawal is not feasible according to guidelines (Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Medications) (2) Lesions less than 5 mm or more than 50 mm in size at the time of preoperative evaluation. (3) Cases in which a histological type other than squamous cell carcinoma, such as Barrett's adenocarcinoma, is suspected. (4) Cases of esophagogastric junction carcinoma in which the resection line does not settle within the squamous epithelium (5) Cases in which the resection is full circumferential (6) Cases after surgical treatment (7) Cases involving scars after endoscopic treatment (8) Cases involving radiotherapy irradiation areas (9) Patients with coagulation disorders (10) Patients on continuous hemodialysis (11) Patients with non-compensated liver cirrhosis (12) Cases that investigators consider inappropriate to conduct this study

Design outcomes

Primary

MeasureTime frame
Major bleeding or not

Secondary

MeasureTime frame
1. The number of blood vessels observed around the lesion 2. Frequency of major/minor bleeding associated with injection 3. The number of hematomas per unit length of the mucosal resection line 4. Procedure time 5. En-block resection rate 6. R0 resection rate 7. Adverse events

Countries

Japan

Contacts

Public ContactKurato Miyazaki

Cancer center Division of research and development for minimally invasive treatment

k.miyazaki30417@gmail.com03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026