Self-Assembling Matrix Forming Gel to Prevent Stricture Formation
- Conditions
- Esophageal StrictureStricture
- Interventions
- Device: Purastat SAP gel application
- Registration Number
- NCT05581173
- Lead Sponsor
- AdventHealth
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endoscopic resection of gastrointestinal lesion(s) Purastat SAP gel application Endoscopic mucosal resection or endoscopic submucosal dissection is an outpatient procedure to remove superficial neoplasia(precancerous lesions and early cancer) throughout the gastrointestinal tract.
- Primary Outcome Measures
Name Time Method Rate of stricture formation 12 months 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.
- Secondary Outcome Measures
Name Time Method Workability of self-assembling peptide (SAP) gel application 12 months The ability to adequately apply the SAP gel over the ulcer bed following resection.
Trial Locations
- Locations (6)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Parkview
🇺🇸Fort Wayne, Indiana, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Baylor St. Lukes
🇺🇸Houston, Texas, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States