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The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Randomized to standard technique and assessment of anastomosis without the use of NIR angiography |
|
| Arm B | Experimental | Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Indocyanine Green/ICG injection | Diagnostic Test | Intravenous Indocyanine Green/ICG injection will be administered for visualization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone | To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone. | 45 days post procedure |
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Participant Inclusion Criteria
Part 1 (pre-operative):
Part 2 (intra-operative):
Participant Exclusion Criteria
Part 1 (pre-operative):
Part 2 (intra-operative):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Leitao, MD | Contact | 212-639-3987 | leitaom@mskcc.org | |
| Dennis Chi, MD | Contact | 212-639-5016 | chid@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Mario Leitao, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38514101 | Derived | Leitao MM Jr, Iasonos A, Tomberlin M, Moukarzel LA, Price H, Bennetti G, Ramesh B, Chi DS, Long Roche K, Sonoda Y, Al-Niami A, Mueller JJ, Gardner GJ, Broach V, Jewell EL, Kim S, Feinberg J, Abu-Rustum NR, Zivanovic O. ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer. Int J Gynecol Cancer. 2024 Jul 1;34(7):1098-1101. doi: 10.1136/ijgc-2024-005395. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| PINPOINT endoscopic fluorescence imaging system | Diagnostic Test | After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis. |
|
| Endoscopy | Diagnostic Test | Standard technique and assessment of anastomosis without the use of NIR angiography |
|
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting | Uniondale | New York | 11553 | United States |
|
| Jefferson Abington Hospital | Recruiting | Willow Grove | Pennsylvania | 19090 | United States |
|
| Houston Methodist Cancer Center (Data Collection Only) | Recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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