NCT06084013 Use Of Indocyanine Green In Pancreas Surgery
| NCT ID | NCT06084013 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Pancreatic Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2024-05-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
Eligibility Criteria
Inclusion Criteria: * Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis * Participant ≥ 18 years of age * Ability to understand nature and individual consequences of clinical trial * Written informed consent from participant or legally authorized representative * For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention * Participant needs to have an operative drain (any closed suction drain) after the procedure * Participants that do not require arterial reconstruction * Participants that require minor portal venous recounstructions including patch venoplasty Exclusion Criteria: * Patients with previous history of adverse reaction to contrast dye, ICG or components of the dye * Prior pancreatectomy * Known diagnosis of hepatic insufficiency, hepatitis, liver fibrosis or cirrhosis, or chronic pancreatitis * Because this study focuses on hypoperfusion, patients will be excluded if in postoperative day 3-5 had any of the following: persistent SBP \<90 mmHg unresponsive to 1L crystalloid, unexpected ICU transfer, blood transfusion of \>2 units intraoperatively or 1 postoperatively, vasopressor treatment or ACLS protocol initiation * Organ failure, anuria or NSQIP-identified complication will be reviewed by PI and attending surgeon and excluded * Patients that require arterial reconstruction as part of their procedures
Contact & Investigator
Patrick J Worth
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT06084013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06084013 currently recruiting?
Yes, NCT06084013 is actively recruiting participants. Contact the research team at salgadog@ohsu.edu for enrollment information.
Where is the NCT06084013 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06084013 clinical trial?
NCT06084013 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Patrick J Worth at OHSU Knight Cancer Institute. The trial plans to enroll 55 participants.