Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Large Esophageal Carcinoma

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Esophageal Stenosis Acquired

Intervention / Treatment
-----------------
* Other: Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)
* Other: Triamcinolone Acetonide (route of administration)
* Other: Prednisone (route of administration)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early esophagus cancer,lesions confined to the mucosal layer,ESD treatment is feasible and the resection range is ≥ 2/3 esophageal perimeter age 18 years or older chest CT scan without lymph node metastasis Exclusion Criteria: patients with early esophagus cancer do not agree with endoscopic treatment occurrence of perforation in ESD requires further treatment lesions invading the muscularis mucosa and below postoperative pathologic assessment of ESD prompting incomplete resection and requiring radiotherapy and chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrocortisone group<br> | Other: Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)<br>* the test group begin to take hydrocortisone sodium succinate mixed with Aluminium Phosphate gel after 24 hours and gradually reduse the dose.<br>|
| Placebo Comparator: prednisone grope<br> | Other: Triamcinolone Acetonide (route of administration)<br>* The control group will get local injection of triamcinolone acetonide in wound during the operation.<br>Other: Prednisone (route of administration)<br>* The control group begin to take oral prednisone after 24 hours and gradually reduse the dose.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal stenosis rate | Esophageal stenosis is defined as that the standard upper gastrointestinal endoscopy with the diameter of 9.2mm can not pass the esophageal lumen. | 3 months after ESD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of endoscopic balloon dilation and its therapeutic effect. | We will compare the rate of endoscopic balloon dilation and its therapeutic effect of the two groups | 3 months after ESD | 
| Healing condition of the wound | healing rate=（area of wound after surgery - remained wound area）/area of wound after surgery | 3 months after ESD | 
| Side effect of drugs | including hypertension、hyperglycemia、electrolyte imbalance etc | 3 months after ESD |