Hydrogel Injection to Assist Endoscopic Submucosal Dissection

NCT03321396 | Completed Results DMC

• 1 other identifier: B-BR-106-022
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Submucosal Tumor of Gastrointestinal Tract

Keywords

Sodium Alginate; Calcium Lactate; Gel

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days after resection

Secondary Outcomes (2)

• Number of Patients With Delayed Bleeding/Perforation

  An average of 4 weeks

• Number of Patients With Late Tissue Injury

  One month after endoscopy

Study Arms (1)

Endoscopic submucosal dissection

EXPERIMENTAL

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

Device: sodium alginate mixed with calcium lactate

Interventions

sodium alginate mixed with calcium lactate DEVICE

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".

Endoscopic submucosal dissection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• The Industrial Technology Research Institute: collaborator
• National Cheng Kung University: collaborator
• National Research Program for Biopharmaceuticals, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 24655031 BACKGROUND

• 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.

  PMID: 27423369 BACKGROUND

Limitations and Caveats

1\. Only 12 patients completed the trial.

Results Point of Contact

• Title: Dr. Xi-Zhang Lin
• Organization: Department of Internal Medicine, National Cheng Kung University

linxz@mail.ncku.edu.tw

886-6-2353535

Study Officials

• Jui-Wen Kang

  Department of Internal Medicine, National Cheng Kung University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 25, 2017
• Study Start: September 1, 2017
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: November 27, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)