Pancreatic CarcinomaNCT06084013
Use Of Indocyanine Green In Pancreas Surgery
An observational study of Pancreatic Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- Non-Interventional Study
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Patrick J. Worth, 503-346-0243, worth@ohsu.edu
Patrick J. Worth
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Pancreatic Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 days after surgery
Perfusion status
Measured by Indocyanine green (ICG) metrics.
Measured: During surgical intervention (hours)
Secondary outcomes (3)
Leak grade via ISGPS classification
Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula
Measured: Up to 30 days after surgery
Leak grade by ICG metrics
ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.
Measured: Up to 30 days after surgery
Best practice usage of ICG for pancreatic surgery
Measures through verbal survey to surgeons or OR members
Measured: Assessed at surgery number 15, approximate 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start29 Feb 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick J. Worth, M.D., F.A.C.S., F.S.S.O., OHSU Knight Cancer Institute
- Investigators
- Patrick J Worth, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084013
- Sponsor's protocol ID
- STUDY00025055
- Other IDs
- NCI-2023-07105, STUDY00025055
- Status last verified
- Aug 2026
- First submitted
- 2 Oct 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
Publications
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 40554527
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks
- ClinicalTrials.gov ID
- NCT06084013
- Acronym / sponsor ID
- STUDY00025055
- Conditions
- Pancreatic Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
Detailed description
PRIMARY OBJECTIVE:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Incidence of biochemical leak or fistula after pancreatectomy.
Time frame: Up to 30 days after surgery
Measurement of drain fluid amylase in post operative period. Defined by definitions of the International Study Group on Pancreatic Surgery (ISGPS) criteria
Perfusion status
Time frame: During surgical intervention (hours)
Measured by Indocyanine green (ICG) metrics.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 40554527Salgado-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick J Worth principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustavo Salgado-Garza, MD (503-494-6900, salgadog@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of biochemical leak or fistula after pancreatectomy. (time frame: Up to 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06084013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.