Clinical trial NCT03321396: 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
Overall status: COMPLETED
Phase: NA
Conditions: Submucosal Tumor of Gastrointestinal Tract
Keywords: Sodium Alginate
Calcium Lactate
Gel
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: The Industrial Technology Research Institute
name: National Cheng Kung University
name: National Research Program for Biopharmaceuticals, Taiwan
First posted: 2017-10-25
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of Patients With Postpolypectomy Electrocoagulation Syndrome
timeFrame: 5 days after resection
Secondary outcomes:
measure: Number of Patients With Delayed Bleeding/Perforation
timeFrame: An average of 4 weeks
measure: Number of Patients With Late Tissue Injury
timeFrame: One month after endoscopy
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Department of Internal Medicine, National Cheng Kung University Hospital
name: Jui-Wen Kang
role: STUDY_DIRECTOR
References:
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.
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.