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| Name | Class |
|---|---|
| Integra LifeSciences Corporation | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MatriStem PSM | Device | All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anastomotic Leak. | Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow) | up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stricture Formation Clinically and by Determination of Dysphagia Score | 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. | 90 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivian Strong, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan Kettering West Harrison |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35426405 | Derived | 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. | |
| 35426404 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Intervention | Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Intervention | Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Anastomotic Leak. | Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow) | Posted | Count of Participants | Participants | up to 10 days |
|
|
Up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Intervention | Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivian Strong, MD | Memorial Sloan Kettering Cancer Center | 212-639-5056 | strongv@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2020 | Oct 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
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| Number of Participants Who Developed Anastomotic Stenosis |
If during the follow up period, patients report any symptoms suggestive of anastomotic stricture, a contrast study (esophagram) or endoscopy will be obtained at that time to evaluate for stricture. These tests will be performed as per standard postoperative assessment by the surgeon. |
| 90 days post op |
| Harrison |
| New York |
| 10604 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Stricture Formation Clinically and by Determination of Dysphagia Score | 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. | Posted | Count of Participants | Participants | 90 days postoperatively |
|
|
|
| Secondary | Number of Participants Who Developed Anastomotic Stenosis | If during the follow up period, patients report any symptoms suggestive of anastomotic stricture, a contrast study (esophagram) or endoscopy will be obtained at that time to evaluate for stricture. These tests will be performed as per standard postoperative assessment by the surgeon. | Posted | Count of Participants | Participants | 90 days post op |
|
|
|
| 29 |
| 78 |
| 18 |
| 78 |
| 8 |
| 78 |
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Death NOS | General disorders | Systematic Assessment |
|
| Esophageal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastric necrosis | Gastrointestinal disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Hepatic infection | Infections and infestations | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
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