Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Large Esophageal Carcinoma
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|ClinicalTrials.gov Identifier: NCT03165344|
Recruitment Status : Enrolling by invitation
First Posted : May 24, 2017
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Stenosis Acquired||Other: Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration) Other: Triamcinolone Acetonide (route of administration) Other: Prednisone (route of administration)||Not Applicable|
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.
The investigators will recruit patients according to admission criteria and exclusion criteria. The patients will be randomly divided into oral hydrocortisone mixed Aluminium Phosphate gel group (experimental group) and local injection of triamcinolone acetonide plus oral prednisone group (control group). The test group begin to take hydrocortisone sodium succinate mixed with Aluminium Phosphate gel after 24 hours and gradually reduse the dose. The control group will get local injection of triamcinolone acetonide in wound during the operation, and begin to take oral prednisone after 24 hours and gradually reduse the dose. The main result is esophageal stenosis rate 3 months after ESD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 10, 2017|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
|Experimental: hydrocortisone group||
Other: Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)
the test group begin to take hydrocortisone sodium succinate mixed with Aluminium Phosphate gel after 24 hours and gradually reduse the dose.
|Placebo Comparator: prednisone grope||
Other: Triamcinolone Acetonide (route of administration)
The control group will get local injection of triamcinolone acetonide in wound during the operation.
Other: Prednisone (route of administration)
The control group begin to take oral prednisone after 24 hours and gradually reduse the dose.
- Esophageal stenosis rate [ Time Frame: 3 months after ESD ]Esophageal stenosis is defined as that the standard upper gastrointestinal endoscopy with the diameter of 9.2mm can not pass the esophageal lumen.
- The rate of endoscopic balloon dilation and its therapeutic effect. [ Time Frame: 3 months after ESD ]We will compare the rate of endoscopic balloon dilation and its therapeutic effect of the two groups
- Healing condition of the wound [ Time Frame: 3 months after ESD ]healing rate=（area of wound after surgery - remained wound area）/area of wound after surgery
- Side effect of drugs [ Time Frame: 3 months after ESD ]including hypertension、hyperglycemia、electrolyte imbalance etc
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165344
|Peking University Third Hospital|
|Beijing, Beijing, China, 100000|
|Principal Investigator:||Yonghui Huang, archiater||Peking University Third Hospital|