Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

Esophageal Stricture Clinical Trial

Official title:

Multicenter Prospective Evaluation of the Efficacy of a Self-Assembling Matrix Forming Gel to Prevent Stricture Formation in High-Risk Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581173
• Other study ID #: 1931151
• Status: Recruiting
• Start date: September 19, 2022
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: AdventHealth
• Contact: Dennis Yang, MD
• Phone: 407-303-2570
• Email: Dennis.Yang.MD[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study is designed as a multicenter prospective registry study evaluating the efficacy of the self-assembling peptide in the prevention of stricture formation after endoscopic resection as part of standard medical care. No experimental interventions will be performed.

Description:

In recent years, endoscopic resection by endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) has become standard practice for the removal of superficial neoplasia (precancerous lesions and early cancer) throughout the gastrointestinal tract. These procedures are associated with lower morbidity and mortality when compared to conventional surgery. Nonetheless, stricture formation following endoscopic resection of gastrointestinal lesions is a well-known risk, particularly in the esophagus. The main risk factor for esophageal stricture formation following EMR/ESD is resection size, with this increasing with the length and extent of the circumferential excision, reaching 100% stricture formation when the entire circumference is involved. Stricture formation is associated with significant morbidity and increasing health care utilization, as multiple endoscopies are often required as part of the management of these difficult to treat strictures. Recently, a self-assembling peptide (SAP) forming gel (Purastat; 3D Matrix, Ltd, Tokyo, Japan) has been approved by the Food and Drug Administration (FDA) as an agent that that promotes healing, which may potentially reduce the risk of stricture formation. Initial small studies from Europe appear to show benefit but the magnitude of the effect has not been well defined. Furthermore, large prospective US based studies are currently lacking. Therefore, the aim of this study is to assess the efficacy of this novel SAP gel in the prevention of stricture formation after endoscopic resection in high-risk patients as utilized as part of clinically indicated standard patient care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2027
• Est. primary completion date: September 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older
• Patients at high-risk for esophageal stricture formation defined as undergoing endoscopic resection in the esophagus involving more than 50% of the circumference

Exclusion Criteria:

• Any standard contraindication to anesthesia and/or endoscopy
• Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Stenosis
• Esophageal Stricture
• Stricture

Intervention

Device:
• Purastat SAP gel application
Purastat is a fully synthetic matrix scaffold that can be applied through an endoscopic catheter. Purastat is FDA approved and commercially available. Purastat is a peptide solution that self assembles at physiological potential Hydrogen(pH) and forms a gel comprising a network of nanofibers. Its benefits in hemostasis and tissue healing and its biocompatibility have been previously demonstrated in animal models and also in human cases. When the gel comes into contact with blood or tissue fluids, the change in potential hydrogen (pH) and salt concentration causes fiber formation and gelation that block the blood vessels in the hemorrhagic area to generate hemostatic effects and also prevention of scar tissue formation.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Parkview	Fort Wayne	Indiana
United States	University of Florida	Gainesville	Florida
United States	Baylor St. Lukes	Houston	Texas
United States	Columbia University Irving Medical Center	New York	New York
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gil ES, Aleksi E, Spirio L. PuraStat RADA16 Self-Assembling Peptide Reduces Postoperative Abdominal Adhesion Formation in a Rabbit Cecal Sidewall Injury Model. Front Bioeng Biotechnol. 2021 Dec 10;9:782224. doi: 10.3389/fbioe.2021.782224. eCollection 2021. — View Citation

Subramaniam S, Kandiah K, Thayalasekaran S, Longcroft-Wheaton G, Bhandari P. Haemostasis and prevention of bleeding related to ER: The role of a novel self-assembling peptide. United European Gastroenterol J. 2019 Feb;7(1):155-162. doi: 10.1177/2050640618811504. Epub 2018 Nov 5. — View Citation

Uraoka T, Ochiai Y, Fujimoto A, Goto O, Kawahara Y, Kobayashi N, Kanai T, Matsuda S, Kitagawa Y, Yahagi N. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc. 2016 Jun;83(6):1259-64. doi: 10.1016/j.gie.2015.11.015. Epub 2015 Dec 1. — View Citation

Wong E, Ho J, Smith M, Sritharan N, Riffat F, Smith MC. Use of Purastat, a novel haemostatic matrix based on self-assembling peptides in the prevention of nasopharyngeal adhesion formation. Int J Surg Case Rep. 2020;70:227-229. doi: 10.1016/j.ijscr.2020.04.027. Epub 2020 May 8. — View Citation

Yu M, Tan Y, Liu D. Strategies to prevent stricture after esophageal endoscopic submucosal dissection. Ann Transl Med. 2019 Jun;7(12):271. doi: 10.21037/atm.2019.05.45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of stricture formation	Esophageal stricture will be defined as symptoms of dysphagia with concomitant endoscopy showing an inability to pass a standard endoscope due to luminal narrowing at the site of the resection scar.	12 months
Secondary	Workability of self-assembling peptide (SAP) gel application	The ability to adequately apply the SAP gel over the ulcer bed following resection.	12 months