Hydrogel Injection to Assist Endoscopic Submucosal Dissection

National Cheng-Kung University

Status: Completed

Conditions: Submucosal Tumor of Gastrointestinal Tract

Treatments: Device: sodium alginate mixed with calcium lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT03321396

B-BR-106-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Endoscopic submucosal dissection

Experimental group

Description:

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

Treatment:

Device: sodium alginate mixed with calcium lactate