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Clinical trial on the safety and effectiveness of collagen hydrogel in preventing esophageal stenosis after ESD for early esophageal cancer

Clinical trial on the safety and effectiveness of collagen hydrogel in preventing esophageal stenosis after ESD for early esophageal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050310
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-08-17
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

esophageal stenosis after ESD

Interventions

Control group:Hormone treatment was started on the third day after ESD and lasted for 8 weeks
Experimental group:Collagen membrane was covered on the wound after ESD, and titanium clip was fixed. Oral hormones were taken from the third day after ESD, and the course of treatment was 8 weeks

Sponsors

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 20 to 70 years; 2.Pathologically confirmed low-grade, high-grade intraepithelial neoplasia or carcinoma in situ of the esophagus; 3.The primary tumor was located in the thoracic esophagus; 4.The depth of tumor invasion was determined to be inside the epidermis or mucosa under endoscopy; 5.CT confirmed no lymph node metastasis, no distant metastasis to the neck, chest and abdomen; 6.The lesion range was more than 3/4 weeks or the whole circumference of the esophagus, and the length diameter was <=5cm under endoscopy; 7.Dysphagia score <0 (Dysphagia score: 0 can eat normally; 1 point no solid food; 2 points can eat half stream; 3 points can only consume liquid; 4 points no fluid.); 8.Organ function is good; 9.Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Complicated with other malignant tumors; 2.Present infection requires systemic treatment; 3.Body temperature >=38?; 4.Pregnant, possibly pregnant, within 28 days after delivery or during lactation; 5.Severe mental illness; 6.Patients who need to take anticoagulant or antiplatelet aggregation drugs for a long time; 7.Hypertension patients with poor control; 8.Patients with unstable angina within 3 weeks or acute myocardial infarction within 6 months; 9.Peptic ulcer; 10.Glaucoma, posterior capsular opacity or corneal herpes; 11.A history of surgical operation within 3 months; 12.Hepatitis B surface antigen/surface antibody or core antibody positive; 13.T-SPOT was positive; 14.Prednisone, PPI allergy; 15.A history of radiotherapy for neck, chest wall, lung and mediastinum; 16.A history of esophageal and mediastinal operations.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative stenosis after endoscopic submucosal dissection;

Secondary

MeasureTime frame
The average number of balloon dilations required under endoscope;Dysphagia score;Supplementary scale for patients with esophageal cancer;

Countries

China

Contacts

Public ContactZou Xiaoping

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

13770771661@163.com+86 13770771661

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026