Submucosal Tumor of Gastrointestinal Tract
Conditions
Keywords
Sodium Alginate, Calcium Lactate, Gel
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.
Interventions
DEVICEsodium 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.
Sponsors
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
National Cheng-Kung University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Postpolypectomy Electrocoagulation Syndrome | 5 days after resection | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Delayed Bleeding/Perforation | An average of 4 weeks | Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection. |
| Number of Patients With Late Tissue Injury | One month after endoscopy | To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Endoscopic Submucosal Dissection |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Taiwan | 12 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 5 days after resection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Submucosal Dissection | Number of Patients With Postpolypectomy Electrocoagulation Syndrome | 0 Participants |
Secondary
Number of Patients With Delayed Bleeding/Perforation
Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.
Time frame: An average of 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Submucosal Dissection | Number of Patients With Delayed Bleeding/Perforation | 1 Participants |
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.
Time frame: One month after endoscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Submucosal Dissection | Number of Patients With Late Tissue Injury | 0 Participants |