A prospective trial to compare the usefulness of NBI versus iodine staining during esophageal squamous carcinoma ESD

JRCT ID: jRCT1052240113

Registered date:22/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal squamous carcinoma
• Date of first enrollment: 20/08/2024
• Target sample size: 400
• Study type: Interventional

Intervention(s)

<Period
From the date of publication of the jrct to December 31, 2026
<Targets
Patients scheduled for endoscopic submucosal dissection (ESD) for superficial esophageal cancer.
<Allocation
Patients will be randomly assigned to group A (NBI + iodine group) or group B (iodine alone group).
A total of 400 patients, 200 in each group, will be enrolled.
<Methods
Group A: After cauterizing the esophageal cancer with an electrocautery scalpel from the tip of the endoscope under NBI, iodine solution will be sprayed to confirm the extent of the non-staining zone that is cancer. If the zone of noncontamination extends beyond the markings, additional markings are added. ESD is performed after marking.
Group B: Mark the perimeter of the zone of noncontamination around the cancerous area under iodine spray. ESD is performed after marking.
<Frequency and volume
The amount of iodine solution to be sprayed and the number of times to be sprayed vary from case to case and lesion to lesion.
<Evaluation
The pathologist will graphically depict the extent of the cancer in the ESD tissue specimen on a photomicrograph of the specimen.
The extent of the marked cancer is compared with the actual extent of cancer, and the success or failure of ESD is compared between the two groups.

Outcome(s)

• Primary Outcome: Percentage of correct diagnosis of tumor extent

Secondary Outcome

Aspiration pneumonia rate, marking time, treatment time, and post-resection ulcer base circumference,
area of resection specimen, percentage of positive horizontal margins, percentage of post-ESD stenosis, percentage of cancer remnant at ESD ulcer healing (2-3 months later), risk factors for misdiagnosis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following selection criteria and do not meet any of the exclusion criteria will be included in this study.
Patients with superficial esophageal cancer
1. patients scheduled to undergo ESD between the jRCT publication date and December 2026
2. patients who are able to undergo endoscopic observation 2-3 months after the date of publication of the jRCT
3. Patients who are at least 20 years of age at the time of the first ESD treatment

Exclude criteria

1. Patients with superficial esophageal cancer of the entire circumference
2. patients who have been previously enrolled in this study
3. pregnant, possibly pregnant, or lactating
4. patients with psychosis or psychiatric symptoms that would make it difficult for them to participate in the study 5. patients with iodine allergy
5. patients who are allergic to iodine and have difficulty with iodine spraying
6. patients scheduled to be treated for advanced cancer of other organs within 3 months
7. patients with a lesion in close proximity to the study site
8. other patients who are deemed inappropriate for the study by the treating physician

Related Information

• Primary Sponsor: Fukunaga Shusei
• Secondary Sponsor: Fujiwara Yasuhiro