Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

AdventHealth

Status: Active, not recruiting

Conditions: Stricture; Esophageal Stricture

Treatments: Device: Purastat SAP gel application

Study type: Observational

Funder types: Other

Identifiers

NCT05581173

1931151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

41 participants in 1 patient group

Endoscopic resection of gastrointestinal lesion(s)

Description:

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

Treatment:

Device: Purastat SAP gel application