NCT03321396

Hydrogel Injection to Assist Endoscopic Submucosal Dissection

Completed NA Results posted Last updated 27 November 2019

What this trial tests

NA trial testing sodium alginate mixed with calcium lactate in Submucosal Tumor of Gastrointestinal Tract in 13 participants. Completed in 20 August 2018.

Timeline

1 September 2017

Primary endpoint
20 August 2018

20 August 2018

Quick facts

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 September 2017
Primary completion	20 August 2018
Estimated completion	20 August 2018
Sites	1 location across Taiwan

Drugs / interventions tested

• sodium alginate mixed with calcium lactate

Conditions studied

• Submucosal Tumor of Gastrointestinal Tract — all drugs for Submucosal Tumor of Gastrointestinal Tract →

Sponsor

National Cheng-Kung University Hospital

Who can join

20 and older, any sex, with Submucosal Tumor of Gastrointestinal Tract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Postpolypectomy Electrocoagulation Syndrome Primary · 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.

Group	Value	95% CI
Endoscopic Submucosal Dissection	0

Number of Patients With Delayed Bleeding/Perforation Secondary · An average of 4 weeks

Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.

Group	Value	95% CI
Endoscopic Submucosal Dissection	1

Number of Patients With Late Tissue Injury Secondary · 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.

Group	Value	95% CI
Endoscopic Submucosal Dissection	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, an average of 6 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Endoscopic Submucosal Dissection

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	Endoscopic Submucosal Diss…
Intraprocedural perforation	Gastrointestinal disorders	—
Intraprocedural bleeding	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03321396 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hydrogels in the clinic.
   Mandal A, Clegg JR, Anselmo AC, Mitragotri S. · · 2020 · cited 265× · PMID 32440563 · DOI 10.1002/btm2.10158
2. Foundations of gastrointestinal-based drug delivery and future developments.
   Chu JN, Traverso G. · · 2022 · cited 136× · PMID 34785786 · DOI 10.1038/s41575-021-00539-w
3. Current and Future Prospective of Injectable Hydrogels-Design Challenges and Limitations.
   Almawash S, Osman SK, Mustafa G, El Hamd MA. · · 2022 · cited 96× · PMID 35337169 · DOI 10.3390/ph15030371
4. Biomedical Application, Patent Repository, Clinical Trial and Regulatory Updates on Hydrogel: An Extensive Review.
   Mohapatra S, Mirza MA, Hilles AR, Zakir F, et al · · 2021 · cited 50× · PMID 34842705 · DOI 10.3390/gels7040207
5. Next-Generation 3D Scaffolds for Nano-Based Chemotherapeutics Delivery and Cancer Treatment.
   Shahriar SMS, Andrabi SM, Islam F, An JM, et al · · 2022 · cited 11× · PMID 36559206 · DOI 10.3390/pharmaceutics14122712
6. Promising Clinical Applications of Hydrogels Associated With Precise Cancer Treatment: A Review.
   Wang QQ, Tan C, Qin G, Yao SK. · · 2023 · cited 9× · PMID 36604973 · DOI 10.1177/15330338221150322
7. Recent Advances in Polysaccharide-Based Hydrogels for Tumor Immunotherapy.
   Zhou Y, Chen K, Cheng H, Zhang S. · · 2025 · cited 4× · PMID 40136857 · DOI 10.3390/gels11030152
8. Clinical translation of injectable hydrogels: from bioactive polymers to long-acting drug delivery systems.
   Carballo-Pedrares N, Giménez VMM, Alonso MJ. · · 2026 · cited 2× · PMID 41571911 · DOI 10.1007/s13346-025-02033-1