Clinical trial · Interventional
Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Large Esophageal Carcinoma
Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Endoscopic submucosal dissection as the fastest growing endoscopic treatment technology in the past decade has been widely used in the treatment of early esophageal cancer and gastric cancer without local lymph node metastasis. The main complications of ESD treatment of early esophageal cancer are hemorrhage, perforation, postoperative esophageal stenosis, infection, etc. Postoperative esophageal stenosis is the most common and major complication after ESD treating patients with lesion involving more than 2/3 esophagus cycle. It is very important to prevent esophageal stricture after ESD. Glucocorticoid is gradually concerned by clinical research because it can inhibit local inflammatory response and reduce the formation of connective tissue in order to prevent postoperative stenosis. The specific usages include endoscopic injection of corticosteroids, oral corticosteroids and combination of them. The study shows that the incidence of esophageal stricture after using glucocorticoid can be reduced effectively. Currently, there is no uniform consensus on the use of glucocorticoids, such as specific drugs, dosage, course of treatment, route of administration. In particular, efficacy comparison of different routes of administration is laking. Studies have shown that endoscopic injection triamcinolone acetonide in some patients with intractable esophageal stricture is not very effective, but it can be treated with oral corticosteroids. Aluminium Phosphate Gel is a kind of neutral buffer. The main component aluminum phosphate can form a strong ion buffer system in acidic environment. The structure of its auxiliary components agar and pectin is similar to that of natural mucus. It forms a mucous layer in the esophagus to restore and protect the esophageal mucosa. Therefore, investigators assume the hydrocortisone sodium succinate aluminum phosphate mixed gel can be used for preventing postoperative ESD stenosis of patients with a large area of early esophageal cancer. This study will design a randomized controlled trial to compare the effect of oral hydrocortisone sodium succinate mixed Aluminium Phosphate Gel and local injection of triamcinolone acetonide plus oral prednisone for the prevention of ESD postoperative esophageal stricture in patients with a large area of early esophageal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Stenosis Acquired | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration) | Other | — | UNRESOLVED |
| Prednisone (route of administration) | Other | — | UNRESOLVED |
| Triamcinolone Acetonide (route of administration) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hydrocortisone group
- interventionNames
- Other: Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)
- type
- PLACEBO_COMPARATOR
- label
- prednisone grope
- interventionNames
- Other: Triamcinolone Acetonide (route of administration)
- Other: Prednisone (route of administration)
Primary outcomes (1)
- measure
- Esophageal stenosis rate
- timeFrame
- 3 months after ESD
- description
- Esophageal stenosis is defined as that the standard upper gastrointestinal endoscopy with the diameter of 9.2mm can not pass the esophageal lumen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. early esophagus cancer,lesions confined to the mucosal layer,ESD treatment is feasible and the resection range is ≥ 2/3 esophageal perimeter 2. age 18 years or older 3. chest CT scan without lymph node metastasis Exclusion Criteria: 1. patients with early esophagus cancer do not agree with endoscopic treatment 2. occurrence of perforation in ESD requires further treatment 3. lesions invading the muscularis mucosa and below 4. postoperative pathologic assessment of ESD prompting incomplete resection and requiring radiotherapy and chemotherapy
References
Publications (12)
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- RESULTMerkow RP, Bilimoria KY, Keswani RN, Chung J, Sherman KL, Knab LM, Posner MC, Bentrem DJ. Treatment trends, risk of lymph node metastasis, and outcomes for localized esophageal cancer. J Natl Cancer Inst. 2014 Jul 16;106(7):dju133. doi: 10.1093/jnci/dju133. Print 2014 Jul. PMID 25031273
- RESULTMizuta H, Nishimori I, Kuratani Y, Higashidani Y, Kohsaki T, Onishi S. Predictive factors for esophageal stenosis after endoscopic submucosal dissection for superficial esophageal cancer. Dis Esophagus. 2009;22(7):626-31. doi: 10.1111/j.1442-2050.2009.00954.x. Epub 2009 Mar 6. PMID 19302207
- RESULTOno S, Fujishiro M, Niimi K, Goto O, Kodashima S, Yamamichi N, Omata M. Predictors of postoperative stricture after esophageal endoscopic submucosal dissection for superficial squamous cell neoplasms. Endoscopy. 2009 Aug;41(8):661-5. doi: 10.1055/s-0029-1214867. Epub 2009 Jun 29. PMID 19565442
- RESULTShi Q, Ju H, Yao LQ, Zhou PH, Xu MD, Chen T, Zhou JM, Chen TY, Zhong YS. Risk factors for postoperative stricture after endoscopic submucosal dissection for superficial esophageal carcinoma. Endoscopy. 2014 Aug;46(8):640-4. doi: 10.1055/s-0034-1365648. Epub 2014 May 15. PMID 24830402
- RESULTHochberger J, Koehler P, Wedi E, Gluer S, Rothstein RI, Niemann H, Hilfiker A, Gonzalez S, Kruse E. Transplantation of mucosa from stomach to esophagus to prevent stricture after circumferential endoscopic submucosal dissection of early squamous cell. Gastroenterology. 2014 Apr;146(4):906-9. doi: 10.1053/j.gastro.2014.01.063. Epub 2014 Feb 8. No abstract available. PMID 24512802
- RESULTMachida H, Tominaga K, Minamino H, Sugimori S, Okazaki H, Yamagami H, Tanigawa T, Watanabe K, Watanabe T, Fujiwara Y, Arakawa T. Locoregional mitomycin C injection for esophageal stricture after endoscopic submucosal dissection. Endoscopy. 2012 Jun;44(6):622-5. doi: 10.1055/s-0032-1306775. Epub 2012 May 25.