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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purastat SAP gel application | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients referred to the participating centers for endoscopic resection of GI lesions may be eligible for entry into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Yang, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | 32803 | United States | ||
| Parkview |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34957076 | Background | 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. | |
| 30788128 | Background | 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. |
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| ID | Term |
|---|---|
| D004940 | Esophageal Stenosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
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|
| Fort Wayne |
| Indiana |
| 46845 |
| United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Baylor St. Lukes | Houston | Texas | 77505 | United States |
| 32422584 | Background | 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. |
| 31355238 | Background | 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. |
| 26608126 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |