Clinical trial · Interventional
Hydrogel Injection to Assist Endoscopic Submucosal Dissection
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)
NCT03321396CI-TRIAL-00041981completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Submucosal Tumor of Gastrointestinal Tract | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sodium alginate mixed with calcium lactate | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic submucosal dissection
- description
- All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.
- interventionNames
- Device: sodium alginate mixed with calcium lactate
Primary outcomes (1)
- measure
- Number of Patients With Postpolypectomy Electrocoagulation Syndrome
- timeFrame
- 5 days after resection
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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).
References
Publications (2)
- BACKGROUNDKusano 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. PMID 24655031
- BACKGROUNDNorouzi 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. PMID 27423369