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Autologous rectal mucosal esophageal transplantation for the prevention of strictures after ESD surgery for large-area early esophageal cancer: a multicenter clinical randomised controlled study

Autologous rectal mucosal esophageal transplantation for the prevention of strictures after ESD surgery for large-area early esophageal cancer: a multicenter clinical randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104316
Enrollment
Unknown
Registered
2025-06-15
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Early Esophageal Cancer

Interventions

Experimental group:Autologous rectal mucosal oesophageal transplantation
Control group: Inject Triamcinolone Acetonide

Sponsors

Department of Gastroenterology, Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, gender not limited; 2. Early esophageal cancer or precancerous lesions, with an area greater than or equal to 3/4 of the circumference and a length greater than or equal to 3cm, or circumferential lesions; 3. Comply with ESD indications; 4. The rectal mucosa is normal, without ulcers or tumors. 5. Voluntarily accept and abide by this experimental protocol, undergo re-examination and follow-up on time, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with esophageal or rectal varicose veins or hemangiomas; 2. Combined with digestive tract lumen stenosis, the endoscope body cannot be inserted. 3. Individuals with severe anemia (hemoglobin =18 seconds), those suffering from bleeding disorders, and those taking oral anticoagulant or antiplatelet drugs who have not been able to stop taking the drugs for the required 5-7 days before the operation as per the guidelines, or who are unable to stop taking the drugs due to their own health conditions; 4. Those with severe heart diseases (NYHA grade >= Grade IV) or lung diseases who are unable to tolerate painless gastroscopy and colonoscopy treatment; 5. Women who are pregnant or breastfeeding at the time of screening; 6. Those who have participated in other clinical trials within three months prior to the trial; 7. Other circumstances where the researcher deems the candidate unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative stenosis and grade of dysphagia;Incidence of refractory oesophageal strictures after surgery;Complications of surgery: perforation;

Secondary

MeasureTime frame
Number of dilations;Duration of surgery;Length of hospital stay;Total cost;Infection;Fistula;Bleeding;

Countries

China

Contacts

Public ContactChaoqiang Fan

Department of Gastroenterology, Second Affiliated Hospital of Army Medical University

fcqxhkwjs@126.com+86 159 2278 1214

Outcome results

None listed

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