NCT01970306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

February 1, 2023

Enrollment Period

9.4 years

First QC Date

October 22, 2013

Results QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Esophageal Adenocarcinoma

Keywords

Esophageal ReinforcementACell MatriStem13-178

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Stricture Formation Clinically and by Determination of Dysphagia Score

    90 days postoperatively

  • Number of Participants Who Developed Anastomotic Stenosis

    90 days post op

Study Arms (1)

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.

Device: MatriStem PSM

Interventions

MatriStem PSMDEVICE

All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.

Surgical intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

    PMID: 35426405DERIVED

  • 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.

    PMID: 35426404DERIVED

Related Links

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Results Point of Contact

Title
Dr. Vivian Strong, MD
Organization
Memorial Sloan Kettering Cancer Center
strongv@mskcc.org
212-639-5056

Study Officials

  • Vivian Strong, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 28, 2013

Study Start

October 18, 2013

Primary Completion

February 24, 2023

Study Completion

February 24, 2023

Last Updated

November 3, 2023

Results First Posted

November 3, 2023

Record last verified: 2023-02

Locations

US(4)