Trial Outcomes & Findings for Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material (NCT NCT01970306)

NCT ID: NCT01970306

Last Updated: 2023-11-03

Results Overview

Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 78 participants
• Primary outcome timeframe: up to 10 days
• Results posted on: 2023-11-03

Participant Flow

Participant milestones

Measure	Surgical Intervention Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Overall Study STARTED	78
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Surgical Intervention Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Overall Study Not eligible	3
Overall Study Not able to be treated	9

Baseline Characteristics

Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Baseline characteristics by cohort

Measure	Surgical Intervention n=78 Participants Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days

Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)

Outcome measures

Measure	Surgical Intervention n=78 Participants Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Number of Participants With Anastomotic Leak. Participants without anastomotic leak	68 Participants
Number of Participants With Anastomotic Leak. Participants diagnosed with anastomotic leak	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgical Intervention n=78 Participants Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Stricture Formation Clinically and by Determination of Dysphagia Score Not evaluable	14 Participants
Stricture Formation Clinically and by Determination of Dysphagia Score No reported dysphagia	54 Participants
Stricture Formation Clinically and by Determination of Dysphagia Score Dysphagia	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgical Intervention n=78 Participants Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Number of Participants Who Developed Anastomotic Stenosis Not evaluable	14 Participants
Number of Participants Who Developed Anastomotic Stenosis Anastomotic stenosis	8 Participants
Number of Participants Who Developed Anastomotic Stenosis No anastomotic stenosis	56 Participants

Adverse Events

Surgical Intervention

Serious events: 18 serious events

Other events: 8 other events

Deaths: 29 deaths

Serious adverse events

Measure	Surgical Intervention n=78 participants at risk Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Gastrointestinal disorders Abdominal pain	1.3% 1/78 • Up to 1 year
Renal and urinary disorders Acute kidney injury	1.3% 1/78 • Up to 1 year
Cardiac disorders Atrial fibrillation	2.6% 2/78 • Up to 1 year
General disorders Death NOS	1.3% 1/78 • Up to 1 year
Injury, poisoning and procedural complications Esophageal anastomotic leak	9.0% 7/78 • Up to 1 year
Gastrointestinal disorders Esophageal stenosis	3.8% 3/78 • Up to 1 year
Injury, poisoning and procedural complications Gastric anastomotic leak	1.3% 1/78 • Up to 1 year
Gastrointestinal disorders Gastric necrosis	1.3% 1/78 • Up to 1 year
Cardiac disorders Heart failure	1.3% 1/78 • Up to 1 year
Infections and infestations Hepatic infection	1.3% 1/78 • Up to 1 year
Gastrointestinal disorders Ileus	1.3% 1/78 • Up to 1 year
Infections and infestations Lung infection	1.3% 1/78 • Up to 1 year
Cardiac disorders Myocardial infarction	1.3% 1/78 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.3% 1/78 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.3% 1/78 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 2/78 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Tracheal fistula	1.3% 1/78 • Up to 1 year
Cardiac disorders Ventricular arrhythmia	1.3% 1/78 • Up to 1 year

Other adverse events

Measure	Surgical Intervention n=78 participants at risk Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM.
Gastrointestinal disorders Stomach pain	6.4% 5/78 • Up to 1 year
Gastrointestinal disorders Diarrhea	1.3% 1/78 • Up to 1 year
Gastrointestinal disorders Dysphagia	1.3% 1/78 • Up to 1 year
Infections and infestations Wound infection	1.3% 1/78 • Up to 1 year

Additional Information

Dr. Vivian Strong, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-5056

Email: strongv@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place