Back to resultsHydrogel Injection to Assist Endoscopic Submucosal Dissection
Primary Purpose
Submucosal Tumor of Gastrointestinal Tract
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
sodium alginate mixed with calcium lactate
Sponsored by
About this trial
This is an interventional treatment trial for Submucosal Tumor of Gastrointestinal Tract focused on measuring Sodium Alginate, Calcium Lactate, Gel
Eligibility Criteria
Inclusion Criteria:
Patients must meet all of the following inclusion criteria in order to be entered into the study:
A. Both genders of patients age 20 or older.
B. Superficial tumors or polyps found either in esophagus, stomach, or large intestine via endoscopic diagnosis.
C. Tumor or polyps ≧ 20 millimeters.
D. Superficial tumor or polyps found either in esophagus, stomach, or large intestine have never received any kind of endoscopic treatment.
E. No evidence of depth of submucosal invasion or metastasis via endoscopy.
Exclusion Criteria:
If patients meet any of the following criteria they may not be entered into the study:
A. Patients suffering from other advanced malignant tumors.
B. White Blood Cell< 2000 μL or Severe thrombocytopenia（Platelet count < 50,000 μL)，or blood coagulation abnormalities uncorrectable .
C. Patients taking anti- thrombocytopenia or anti-coagulation medicine, and medication cannot be stopped under physicians' consideration.
D. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
E. Evidence of depth of submucosal invasion or metastasis via endoscopy.
F. Unable to follow-up by endoscopy.
G. Unwilling to sign informed consent.
H. Allergic to pharmaceutical excipients related to this medical device (Calcium Lactate or Sodium Alginate).
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopic submucosal dissection
Arm Description
All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.
Outcomes
Primary Outcome Measures
Number of Patients With Postpolypectomy Electrocoagulation Syndrome
To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.
Secondary Outcome Measures
Number of Patients With Delayed Bleeding/Perforation
Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.
Number of Patients With Late Tissue Injury
To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.
Full Information
NCT ID
NCT03321396
First Posted
September 20, 2017
Last Updated
November 19, 2019
Sponsor
National Cheng-Kung University Hospital
Collaborators
The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03321396
Brief Title
Hydrogel Injection to Assist Endoscopic Submucosal Dissection
Official Title
Gut Guarding Gel for Endoscopic Resection to Treat Early Gastroenterological Tumor and Polyps (Evaluation of the Safety of Sodium Alginate Mixed With Calcium Lactate on Endoscopic Mucosal Resection / Endoscopic Submucosal Dissection)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan
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
The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection.
Detailed Description
The study will evaluate the mucosa-elevating capacity and clinical safety of Gut Guarding Gel (the Sodium Alginate (SA) mixed with Calcium Lactate) in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection to treat early gastroenterological tumor and polyps.
All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.
The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Determine the rates of the delayed bleeding/perforation, postpolypectomy electrocoagulation syndrome, and the late tissue injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submucosal Tumor of Gastrointestinal Tract
Keywords
Sodium Alginate, Calcium Lactate, Gel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic submucosal dissection
Arm Type
Experimental
Arm Description
All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.
Intervention Type
Device
Intervention Name(s)
sodium alginate mixed with calcium lactate
Intervention Description
The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Primary Outcome Measure Information:
Title
Number of Patients With Postpolypectomy Electrocoagulation Syndrome
Description
To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.
Time Frame
5 days after resection
Secondary Outcome Measure Information:
Title
Number of Patients With Delayed Bleeding/Perforation
Description
Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.
Time Frame
An average of 4 weeks
Title
Number of Patients With Late Tissue Injury
Description
To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.
Time Frame
One month after endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must meet all of the following inclusion criteria in order to be entered into the study:
A. Both genders of patients age 20 or older.
B. Superficial tumors or polyps found either in esophagus, stomach, or large intestine via endoscopic diagnosis.
C. Tumor or polyps ≧ 20 millimeters.
D. Superficial tumor or polyps found either in esophagus, stomach, or large intestine have never received any kind of endoscopic treatment.
E. No evidence of depth of submucosal invasion or metastasis via endoscopy.
Exclusion Criteria:
If patients meet any of the following criteria they may not be entered into the study:
A. Patients suffering from other advanced malignant tumors.
B. White Blood Cell< 2000 μL or Severe thrombocytopenia（Platelet count < 50,000 μL)，or blood coagulation abnormalities uncorrectable .
C. Patients taking anti- thrombocytopenia or anti-coagulation medicine, and medication cannot be stopped under physicians' consideration.
D. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
E. Evidence of depth of submucosal invasion or metastasis via endoscopy.
F. Unable to follow-up by endoscopy.
G. Unwilling to sign informed consent.
H. Allergic to pharmaceutical excipients related to this medical device (Calcium Lactate or Sodium Alginate).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jui-Wen Kang
Organizational Affiliation
Department of Internal Medicine, National Cheng Kung University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24655031
Citation
Kusano T, Etoh T, Akagi T, Ueda Y, Shiroshita H, Yasuda K, Satoh M, Inomata M, Shiraishi N, Kitano S. Evaluation of 0.6% sodium alginate as a submucosal injection material in endoscopic submucosal dissection for early gastric cancer. Dig Endosc. 2014 Sep;26(5):638-45. doi: 10.1111/den.12268. Epub 2014 Mar 24.
Results Reference
background
PubMed Identifier
27423369
Citation
Norouzi M, Nazari B, Miller DW. Injectable hydrogel-based drug delivery systems for local cancer therapy. Drug Discov Today. 2016 Nov;21(11):1835-1849. doi: 10.1016/j.drudis.2016.07.006. Epub 2016 Jul 14.
Results Reference
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Hydrogel Injection to Assist Endoscopic Submucosal Dissection
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