Recruiting NCT06084013

Use Of Indocyanine Green In Pancreas Surgery

— Observational Pancreatic Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Non-Interventional Study.
Who it may be relevant to: Registry conditions: Pancreatic Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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.

Incidence of biochemical leak or fistula after pancreatectomy. [Time frame: Up to 30 days after surgery]
Perfusion status [Time frame: During surgical intervention (hours)]

Secondary outcome measures (3)

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]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

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. PMID 40554527

NCT: NCT06084013 · STUDY00025055 · NCI-2023-07105 · STUDY00025055