Clinical trial NCT01970306: Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Official title: A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Adenocarcinoma
Keywords: Esophageal Reinforcement
ACell MatriStem
13-178
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2013-10-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older
* Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal, adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at other institutions but slides must be confirmed at MSKCC or a participating site, as is routine care at our institution)
* Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent. Including but not limited to esophagectomy or total gastrectomy.
* Subject is willing to provide written informed consent
* Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

* Pregnant or lactating women
* Intraoperative evidence of metastatic or locally-unresectable disease
* Patients with known sensitivity or allergy to porcine materials.
* Patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent.

Primary outcomes:
measure: Number of Participants With Anastomotic Leak.
timeFrame: up to 10 days
Secondary outcomes:
measure: Stricture Formation Clinically and by Determination of Dysphagia Score
timeFrame: 90 days postoperatively
measure: Number of Participants Who Developed Anastomotic Stenosis
timeFrame: 90 days post op
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vivian Strong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vos EL, Nakauchi M, Capanu M, Park BJ, Coit DG, Molena D, Yoon SS, Jones DR, Strong VE. Phase II Trial Evaluating Esophageal Anastomotic Reinforcement with a Biologic, Degradable, Extracellular Matrix after Total Gastrectomy and Esophagectomy. J Am Coll Surg. 2022 May 1;234(5):910-917. doi: 10.1097/XCS.0000000000000113.
citation: Shannon AB, Straker RJ 3rd, Fraker DL, Miura JT, Karakousis GC. Validated Risk-Score Model Predicting Lymph Node Metastases in Patients with Non-Functional Gastroenteropancreatic Neuroendocrine Tumors. J Am Coll Surg. 2022 May 1;234(5):900-909. doi: 10.1097/XCS.0000000000000144.