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Completed

NCT Number: NCT03039608

Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who has undergone esophageal ESD
  • Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
  • ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.

Exclusion criteria

  • Severe circulatory or respiratory disease,severe renal impairment
  • Women in pregnancy and lactation
  • Patients with steroid contraindications
  • Patients refuse to join in this study

Treatment and study plan

combination of local steroid injection(triamcinolone )with oral steroid administration(prednisone)

Drug

local steroid injection and oral steroid

oral steroid administration(prednisone)

Drug

oral steroid

Primary outcomes

  1. the stricture rate

    Time frame: 12weeks

    the incidence of esophageal rate after ESD

  2. the time when stricture occurs

    Time frame: 12weeks

Secondary outcomes

  1. the frequency of dilatation sessions required

    Time frame: 12 months

    the frequency of dilatation sessions required after stricture

  2. the frequency of complications

    Time frame: 12 months

    complications related with steroid administrations or the process of ESD

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm:a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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