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

Primary Purpose

Esophageal Stenosis Acquired

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)
Triamcinolone Acetonide (route of administration)
Prednisone (route of administration)
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Stenosis Acquired

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

hydrocortisone group

prednisone grope

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Healing condition of the wound
healing rate=(area of wound after surgery - remained wound area)/area of wound after surgery
Side effect of drugs
including hypertension、hyperglycemia、electrolyte imbalance etc

Full Information

First Posted
April 7, 2017
Last Updated
January 18, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03165344
Brief Title
Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Large Esophageal Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stenosis Acquired

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydrocortisone group
Arm Type
Experimental
Arm Title
prednisone grope
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)
Intervention Description
the test group begin to take hydrocortisone sodium succinate mixed with Aluminium Phosphate gel after 24 hours and gradually reduse the dose.
Intervention Type
Other
Intervention Name(s)
Triamcinolone Acetonide (route of administration)
Intervention Description
The control group will get local injection of triamcinolone acetonide in wound during the operation.
Intervention Type
Other
Intervention Name(s)
Prednisone (route of administration)
Intervention Description
The control group begin to take oral prednisone after 24 hours and gradually reduse the dose.
Primary Outcome Measure Information:
Title
Esophageal stenosis rate
Description
Esophageal stenosis is defined as that the standard upper gastrointestinal endoscopy with the diameter of 9.2mm can not pass the esophageal lumen.
Time Frame
3 months after ESD
Secondary Outcome Measure Information:
Title
The rate of endoscopic balloon dilation and its therapeutic effect.
Description
We will compare the rate of endoscopic balloon dilation and its therapeutic effect of the two groups
Time Frame
3 months after ESD
Title
Healing condition of the wound
Description
healing rate=(area of wound after surgery - remained wound area)/area of wound after surgery
Time Frame
3 months after ESD
Title
Side effect of drugs
Description
including hypertension、hyperglycemia、electrolyte imbalance etc
Time Frame
3 months after ESD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonghui Huang, archiater
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Large Esophageal Carcinoma

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