Use Of Indocyanine Green In Pancreas Surgery

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Non-Interventional Study
  Non-interventional study

Первичные конечные точки

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

Вторичные конечные точки (3)

• Leak grade via ISGPS classification [Срок оценки: Up to 30 days after surgery]
• Leak grade by ICG metrics [Срок оценки: Up to 30 days after surgery]
• Best practice usage of ICG for pancreatic surgery [Срок оценки: Assessed at surgery number 15, approximate 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• OHSU Knight Cancer Institute — Portland

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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