Esophageal Adenocarcinoma
Conditions
Keywords
Esophageal Reinforcement, ACell MatriStem, 13-178
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.
Interventions
DEVICEMatriStem PSM
All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
Sponsors
Integra LifeSciences Corporation
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anastomotic Leak. | up to 10 days | Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stricture Formation Clinically and by Determination of Dysphagia Score | 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. |
| Number of Participants Who Developed Anastomotic Stenosis | 90 days post op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgical Intervention Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not able to be treated | 9 |
| Overall Study | Not eligible | 3 |
Baseline characteristics
| Characteristic | Surgical Intervention |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Region of Enrollment United States | 78 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 29 / 78 |
| other Total, other adverse events | 8 / 78 |
| serious Total, serious adverse events | 18 / 78 |
Outcome results
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)
Time frame: up to 10 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgical Intervention | Number of Participants With Anastomotic Leak. | Participants diagnosed with anastomotic leak | 10 Participants |
| Surgical Intervention | Number of Participants With Anastomotic Leak. | Participants without anastomotic leak | 68 Participants |
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.
Time frame: 90 days post op
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgical Intervention | Number of Participants Who Developed Anastomotic Stenosis | Not evaluable | 14 Participants |
| Surgical Intervention | Number of Participants Who Developed Anastomotic Stenosis | Anastomotic stenosis | 8 Participants |
| Surgical Intervention | Number of Participants Who Developed Anastomotic Stenosis | No anastomotic stenosis | 56 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.
Time frame: 90 days postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgical Intervention | Stricture Formation Clinically and by Determination of Dysphagia Score | Not evaluable | 14 Participants |
| Surgical Intervention | Stricture Formation Clinically and by Determination of Dysphagia Score | No reported dysphagia | 54 Participants |
| Surgical Intervention | Stricture Formation Clinically and by Determination of Dysphagia Score | Dysphagia | 10 Participants |