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A study on the effect of trimethoprim plus thioglycollate gel filling for the prevention of postoperative stricture in large esophageal ESD

A study on the effect of trimethoprim plus thioglycollate gel filling for the prevention of postoperative stricture in large esophageal ESD

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066181
Enrollment
Unknown
Registered
2022-11-26
Start date
2022-11-14
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Stenosis after large endoscopic submucosal dissection

Interventions

experimental group:Postoperative wound filling with tretinoin + thioglycollate gel
positive control group:Postoperative wound filling with tretinoin + saline
blank control group:Postoperative wounds are filled with saline only

Sponsors

Hainan Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Endoscopic examination indicated esophageal mucosal lesions, which were brown and had clear boundaries under electron staining. The endoscopic diagnosis criteria of early esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia were met under magnification endoscopy; 2. Endoscopic ultrasound suggested that the lesion was hypoechoic, confined to the mucosa, and the submucosa was continuous and complete; 3. The lesions involved 3/4 or more of the circumferential esophagus; 4. Enhanced esophageal CT showed no invasive tumor growth and no involvement of peripheral lymph nodes; 5. Patients with high-grade intraepithelial neoplasia or intramucosal carcinoma indicated by biopsy pathology, which met the indications of endoscopic ESD treatment.

Exclusion criteria

Exclusion criteria: 1. Definite advanced esophageal cancer patients; 2. Endoscopic ultrasound suggested that the lesions involved submucosa or even deeper, and did not conform to ESD treatment indications; 3. Enhanced esophageal CT indicated peripheral lymph node invasion and distant metastasis; 4. Serious heart and lung disease, serious liver and kidney disease, serious blood system disease; 5. Patients with coagulation dysfunction.

Design outcomes

Primary

MeasureTime frame
The duration of drug retention in the wound;Incidence of mild and severe stenosis;The response rate of standard two drug fillers;

Secondary

MeasureTime frame
The number of times the refill drug was appended;

Countries

China

Contacts

Public ContactWeiguang Li

Hainan Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

liweiguang2006@126.com+86 138 1632 0556

Outcome results

None listed

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