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RecruitingObservational

Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks

NCT ID: NCT06084013Sponsor: OHSU Knight Cancer InstituteLast updated: 2025-07-25

Summary

This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.

Detailed description

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.

Arms & interventions

  • OtherNon-Interventional Study

    Non-interventional study

Outcome measures

Primary

  • 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

    Time frame: Up to 30 days after surgery

  • Perfusion status

    Measured by Indocyanine green (ICG) metrics.

    Time frame: During surgical intervention (hours)

Secondary

  • Leak grade via ISGPS classification

    Time frame: Up to 30 days after surgery

  • Leak grade by ICG metrics

    Time frame: Up to 30 days after surgery

  • Best practice usage of ICG for pancreatic surgery

    Time frame: Assessed at surgery number 15, approximate 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Recruiting
Patrick J. Worth · Contact
Patrick J. Worth · Principal Investigator

References

  • 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.(PubMed)
Use Of Indocyanine Green In Pancreas Surgery | Cancerify