Esophageal Stricture
Conditions
Keywords
esophageal stricture, endoscopic submucosal dissection, prevention
Brief summary
The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries. However, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy. Although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected. In previous study by Ono et al，it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal ESD. There were some reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled that just oral prednisolone oral is effective option for the prevention of post-ESD stricture. However, most of the reported studies were non RCTs with small sample. In the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive ESD.
Interventions
DRUGcombination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）
local steroid injection and oral steroid
DRUGoral steroid administration（prednisone）
oral steroid
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who has undergone esophageal ESD 2. Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus 3. ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.
Exclusion criteria
1. Severe circulatory or respiratory disease，severe renal impairment 2. Women in pregnancy and lactation 3. Patients with steroid contraindications 4. Patients refuse to join in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the stricture rate | 12weeks | the incidence of esophageal rate after ESD |
| the time when stricture occurs | 12weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the frequency of dilatation sessions required | 12 months | the frequency of dilatation sessions required after stricture |
| the frequency of complications | 12 months | complications related with steroid administrations or the process of ESD |
Countries
China
Outcome results
None listed