Efficacy and Safety of Peptide-derived Hemostatic Material for the Prevention of Post-Esophageal ESD Stenosis

JRCT ID: jRCTs062220110

Registered date:22/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: superficial esophageal carcinoma
• Date of first enrollment: 05/07/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Peptide-derived hemostatic material (PuraStat) is applied evenly and appropriately to the post-ESD ulcer base of esophageal tumors immediately after ESD and at the end of the 2nd look, with an upper limit of 20 mL each.

Outcome(s)

• Primary Outcome: Percentage of stenosis by 12 weeks after ESD
• Secondary Outcome: Stenosis-free survival, number of endoscopic dilatations required up to 12 weeks after ESD, percentage of Dysphagia score<=1 at 12 weeks after ESD, incidence of adverse events, incidence of serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Histologically or endoscopically confirmed primary squamous cell carcinoma (including HGIN) or basal cell carcinoma of the esophagus by endoscopic biopsy or image-enhanced magnifying endoscopy.
2. Endoscopic diagnosis of tumor confined to the thoracic esophagus.
3. Endoscopic diagnosis of tumor wall depth within the epithelium (EP), mucosal lamina propria (LPM), or mucosal muscularis mucosae (MM).
4. No evidence of lymph node or distant metastasis on cervical to abdominal contrast-enhanced CT or PET-CT. Simple CT is acceptable in the presence of renal dysfunction, contrast allergy, or bronchial asthma.
5. The tumor is more than 1/2 circumferential and non-total circumferential. If the tumor is more than 1/2 circumferential and non-peripheral, the circumference of the resected area is expected to be 3/4 circumferential to subperipheral.
6. Tumor diameter is less than 50 mm in the longitudinal direction at endoscopic examination.
7. If multiple lesions are present, all secondary lesions except the most circumscribed lesion (main lesion) have a circumference of less than 1/2 circumference.
8. Age on the date consent is obtained is at least 18 years old and less than 85 years old.
9. Performance status (PS) is 0-1 according to ECOG criteria.
10. No prior radiation therapy to the cervicothoracic region, lung fields, or mediastinum, including treatment for other types of carcinoma.
11. No previous surgery to the esophagus or mediastinum, including treatment for benign tumors.
12. No prior treatment for esophageal carcinoma.
13. Dysphagia score is 0.
14. The most recent laboratory values within 90 days prior to provisional enrollment meet all of the following
(1) White blood cell count >=2,000/mm3 and <=12,000/mm3
(2) Hemoglobin >=8.0 g/dL
(3) Platelet count >=10,000/ mm3
(4) Total bilirubin <=2.0 mg/dL
(5) AST (GOT) <=150 IU/L
(6) ALT (GPT) <=150 IU/L
(7) Serum creatinine <=2.0 mg/dL
(8) Hemoglobin A1c (international standard (NGSP) value) <7.0
15. The patient's written consent to participate in the study has been obtained.
16. ESD was performed, and at the end of ESD, the resection area was confirmed to be 3/4 circumference to sub-total circumference.

Exclude criteria

1. Active overlapping cancers.
2. Infections requiring systemic treatment.
3. Fever of 38 degrees or higher at axillary temperature at the time of registration.
4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
5. Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
6. Receiving continuous systemic administration of steroids or other immunosuppressive agents.
7. Receiving a steroid combination inhaler.
8. Complicated by poorly controlled hypertension.
9. Complicated unstable angina (angina with onset or worsening attacks within the last 3 weeks) or history of myocardial infarction within 6 months.
10. Complicated respiratory disease requiring continuous oxygen administration.
11. Previous surgery within 3 months (regardless of surgical site).
12. History of hypersensitivity to peptide or protein preparations.

Related Information

• Primary Sponsor: Oka Shiro
• Source(s) of Monetary Support: 3D MATRIX