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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-07105 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00025055 | Other Identifier | OHSU Knight Cancer Institute |
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This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
PRIMARY OBJECTIVE:
I. To determine if altered measurement results of ICG after pancreatectomy is associated with leak rates.
OUTLINE: This is an observational study.
Patients receive indocyanine green intravenously (IV) during surgery, undergo imaging and have their medical records reviewed on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biochemical leak or fistula after pancreatectomy. | Measurement of drain fluid amylase in post operative period. Defined by definitions of the International Study Group on Pancreatic Surgery (ISGPS) criteria | Up to 30 days after surgery |
| Perfusion status | Measured by Indocyanine green (ICG) metrics. | During surgical intervention (hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Leak grade via ISGPS classification | Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula | Up to 30 days after surgery |
| Leak grade by ICG metrics |
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Inclusion Criteria:
Exclusion Criteria:
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Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Salgado-Garza, MD | Contact | 503-494-6900 | salgadog@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrick J Worth | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40554527 | Derived | Salgado-Garza G, Willy A, Rocha FG, Mayo SC, Sheppard BC, Worth PJ. The VIPR-1 trial (Visualizing Ischemia in the Pancreatic Remnant): Assessing the role of intraoperative indocyanine green perfusion in predicting postoperative pancreatic leaks and fistulas: Protocol for a phase II clinical trial. PLoS One. 2025 Jun 24;20(6):e0311025. doi: 10.1371/journal.pone.0311025. eCollection 2025. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.
| Up to 30 days after surgery |
| Best practice usage of ICG for pancreatic surgery | Measures through verbal survey to surgeons or OR members | Assessed at surgery number 15, approximate 6 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |