Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Stricture; Stricture
• Intervention / Treatment: Device: Purastat SAP gel application

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • Texas
    • Houston, Texas, United States, 77505
      • Baylor St. Lukes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients referred to the participating centers for endoscopic resection of GI lesions may be eligible for entry into the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Endoscopic resection of gastrointestinal lesion(s); Endoscopic mucosal resection or endoscopic submucosal dissection is an outpatient procedure to remove superficial neoplasia(precancerous lesions and early cancer) throughout the gastrointestinal tract.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workability of self-assembling peptide (SAP) gel application	The ability to adequately apply the SAP gel over the ulcer bed following resection.	12 months

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Dennis Yang, MD, AdventHealth

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID Numbers: 1931151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No