Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
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|ClinicalTrials.gov Identifier: NCT01970306|
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : February 28, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Esophageal Adenocarcinoma||Device: MatriStem PSM||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material|
|Actual Study Start Date :||October 18, 2013|
|Actual Primary Completion Date :||February 24, 2023|
|Actual Study Completion Date :||February 24, 2023|
Experimental: Surgical intervention
Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. Patients undergoing esophagectomy, PG or TG will be evaluated with one routine postoperative contrast swallow study at post-operative day #4-10.
Device: MatriStem PSM
All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
- rates of anastomotic leak. [ Time Frame: up to 10 days ]Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)
- stricture formation clinically and by determination of dysphagia score [ Time Frame: 90 days postoperatively ]Patients will be evaluated in the outpatient clinic and will be assigned a dysphagia score from 0-4 by the RSA. Patients reporting symptoms consistent with stricture will be evaluated with radiographic contrast swallow study or endoscopy.
- cost metrics [ Time Frame: postoperatively (+/- 14 days) ]Data for cost metrics will be collected postoperatively through POD90 (+/- 14 days). These include metrics such as Length of Stay, Readmission, Complications, Reoperation and Total Hospital Bill.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970306
|United States, New Jersey|
|Memorial Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering West Harrison|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|Md Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vivian Strong, MD||Memorial Sloan Kettering Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Memorial Sloan Kettering Cancer Center|
|Other Study ID Numbers:||
|First Posted:||October 28, 2013 Key Record Dates|
|Last Update Posted:||February 28, 2023|
|Last Verified:||February 2023|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type