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| Name | Class |
|---|---|
| The Industrial Technology Research Institute | OTHER |
| National Cheng Kung University | OTHER |
| National Research Program for Biopharmaceuticals, Taiwan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic submucosal dissection | Experimental | All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium alginate mixed with calcium lactate | Device | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days after resection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Delayed Bleeding/Perforation | Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection. | An average of 4 weeks |
| Number of Patients With Late Tissue Injury |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Jui-Wen Kang | Department of Internal Medicine, National Cheng Kung University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24655031 | Background | 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. | |
| 27423369 | Background |
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The recruitment started in January 2017. The location was taken place at National Cheng Kung University Hospital. Patients who met the inclusion criteria were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endoscopic Submucosal Dissection | All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: 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". |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopic Submucosal Dissection | All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: 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". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 5 days after resection |
|
Through study completion, an average of 6 weeks.
No adverse events occurred, such as fever, severe abdominal pain and delay-bleeding.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endoscopic Submucosal Dissection | All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: 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". |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraprocedural perforation | Gastrointestinal disorders | Non-systematic Assessment |
1. Only 12 patients completed the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xi-Zhang Lin | Department of Internal Medicine, National Cheng Kung University | 886-6-2353535 | 6202 | linxz@mail.ncku.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2017 | Nov 18, 2019 | Prot_SAP_001.pdf |
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|
To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.
| One month after endoscopy |
| 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Number of Patients With Delayed Bleeding/Perforation | Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection. | Posted | Count of Participants | Participants | An average of 4 weeks |
|
|
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| Secondary | 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. | Posted | Count of Participants | Participants | One month after endoscopy |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| Intraprocedural bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
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