Pancreatic NeoplasmsNCT02863783
EUS Fiducial for Pancreas Surgery
A study testing EUS with Fiducial in people with Pancreatic Neoplasms, run by University of Southern California at 1 site in United States.
Trial summary
RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been developed which enables fiducial coils to be placed at the precise site of biopsy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- EUS with Fiducial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2016to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing endoscopic ultrasound for preoperative evaluation before planned pancreatic surgery for suspected adenocarcinoma and neuroendocrine tumors will be eligible. Rapid onsite evaluation is performed for all pancreas EUS as part of standard procedures. In this process the cytologist examines the cells and makes a determination whether the aspirate contains malignant or benign tissue. Fiducials will only be placed if cytologic confirmation of malignancy at the site is obtained.
- Tumors of sizes 5mm-4cm will be eligible as there may be benefit in marking small tumors given difficulty finding them with intraoperative ultrasound. Moderately large pancreas tumors may also cause fibrosis which makes identification for resection difficult. Coil placement in regions of cytologically confirmed malignant cells may be helpful. Fiducial markers will only be placed if the initial evaluation (abdominal computed tomography or magnetic resonance imaging) indicates resectability. If finding of nonresectability (i.e. liver metastasis) are seen on EUS then fiducials will not be placed.
Who cannot join
- 1) Patients with INR >1.5 2) Platelet county <100 3) Metal allergy 4) Pregnant 5) <18 years of age 6) Patients with pancreatic lymphoma will also be excluded as this is treated with chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County Hospital
Los Angeles, California, 90033
About this study
Official title: Pilot Trial of Endoscopic Ultrasound Guided Coil Placement to Facilitate Intraoperative Assessment of Pancreas Tumors
RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been developed which enables fiducial coils to be placed at the precise site of biopsy.
INTERVENTION: At time of EUS guided biopsy the fine needle fiducial device will be used to place fiducials in the tumor. During surgery we will assess whether it improves tumor visualization.
Read more
OBJECTIVES: We aim to determine the feasibility to use EUS guided fiducials placement to mark pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization during pancreas surgery.
STUDY POPULATION: Patients with pancreas adenocarcinoma or neuroendocrine lesions.
STUDY ENDPOINTS: The main outcome will be to assess whether the coil may be successfully placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and ANALYSIS: Patients will be assessed at the time of EUS and surgery. This is a pilot analysis with the intention to assess feasibility and to gather data to power larger trials.
Read the detailed description
Minimally invasive pancreatic surgery diminishes the morbidity and mortality of the potentially curative procedures. However precise targeting of small adenocarcinomas and neuroendocrine tumors is challenging.
Given safety, precision, and ease EUS guided pancreatic fiducial placement has emerged as a favored method to mark tumors for radiation therapy. The experimental aspect of this procedure is gauge whether EUS guided fiducial placement improves the intraoperative assessment of pancreas tumors. We will use the recently introduced (FDA approved) Beacon EUS guided fiducial system to perform placement. The fiducial will not alter the surgical plan in this study. However, the relative ability to detect the marker during standard pancreatic surgery will help to inform whether this strategy may be used in improve future approaches to pancreas surgery.
The study will be a prospective trial. All EUS will be performed as part of standard clinical care.
Conventional EUS+FNA The linear array echoendoscope will be used to identify the pancreas adenocarcinoma and neuroendocrine tumors. The Beacon EUS system/delivery sheath will be passed and fine needle aspiration performed to confirm cytology. This is required for standard clinical care. The delivery sheath will be left in place. The cytologist will perform bedside interpretation as is standard clinical care.
EUS guided coil injection If adenocarcinoma or neuroendocrine tumor is confirmed by fine needle aspiration the fine needle fiducial accessory will be passed through the delivery sheath (whose position on the tumor is now "biopsy confirmed" and 1-3 fiducials (coil type) will be introduced into the lesion. This process will be guided by EUS which is being performed for standard clinical care. Fluoroscopy not be utilized.
Pancreas Surgery: At time of surgery the experimental component is that it will be gauged whether the fiducial impacts the ability to assess the tumor relative to lesions of comparable size. Whether the fiducial improves or does not improve assessment will be scaled on a 1-10 scale where 5 is the standard ease of detection of similarly sized tumors (without fiducials) based on the attending surgeon's experience.
However, the fiducial will not be used to target the lesion or alter the surgical plan. The surgical plan will be based on preoperative clinical imaging, intraoperative findings, and intraoperative ultrasound (standard clinical care). The research coordinator will be present during surgery to facilitate timely acquisition of data. In some cases patient are deemed to not be resection candidates at the time of surgery if for example unexpected metastasis are found. The EUS guided fiducial placement will have no bearing on whether resection is done or not.
- Conditions
- Pancreatic Neoplasms
- Being tested
- EUS with Fiducial
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS with FiducialDevice
EUS will be used to place fiducial into pancreas tumor at time of biopsy
| Study group | Role | What they receive |
|---|---|---|
| Fiducial Placement | Experimental | EUS with Fiducial Placement into Tumor Receives: Device: EUS with Fiducial |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted
the primary outcome will be to assess whether the coil may be successfully placed. This will be reported as the proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted.
Measured: 3 months
Relative Ease of Detection of the Tumor with Fiducial
A co-primary outcome will be to assess whether the coil may detected at time of surgery. The proportion of patients in whom the fiducial may be easily detected will also be reported. The relative ease of detection of the tumor (with fiducial) will be compared to the ease of detection of similar sized tumors without the fiducial. A QUESTIONNAIRE will be used in which each of detection by the attending surgeon will be recorded with 5 being each of detection of similar (histology/size) tumor without fiducial.
Measured: 3 months
Secondary outcomes (1)
Pancreatitis, abdominal pain, infection, bleeding following placement.
all complications including acute pancreatitis, abdominal pain, infection, bleeding following EUS guided fiducial placement will be recorded and reported. This will also be reported as the proportion of patients who develop a complication divided by total patients. Individual types of complications will be similarly reported.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start23 Nov 2016
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Buxbaum, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863783
- Sponsor's protocol ID
- HS-16-00032
- Status last verified
- Mar 2023
- First submitted
- 31 Jul 2016
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park WG, Yan BM, Schellenberg D, Kim J, Chang DT, Koong A, Patalano C, Van Dam J. EUS-guided gold fiducial insertion for image-guided radiation therapy of pancreatic cancer: 50 successful cases without fluoroscopy. Gastrointest Endosc. 2010 Mar;71(3):513-8. doi: 10.1016/j.gie.2009.10.030.
PubMed 20189509Farrell JJ, Sherrod A, Parekh D. EUS-guided fine-needle tattooing for preoperative localization of early pancreatic adenocarcinoma. Gastrointest Endosc. 2009 Jan;69(1):176-7. doi: 10.1016/j.gie.2008.03.1069. Epub 2008 Jul 2. No abstract available.
PubMed 18599051Lennon AM, Newman N, Makary MA, Edil BH, Shin EJ, Khashab MA, Hruban RH, Wolfgang CL, Schulick RD, Giday S, Canto MI. EUS-guided tattooing before laparoscopic distal pancreatic resection (with video). Gastrointest Endosc. 2010 Nov;72(5):1089-94. doi: 10.1016/j.gie.2010.07.023.
PubMed 21034909Chang PW, Sadik J, Sahakian AB, Kankotia R, Ko C, Serna J, Rodriguez A, Lee H, Kulkarni S, Genyk Y, Sheikh M, Buxbaum JL. A Preliminary Controlled Trial of Endoscopic Ultrasound-guided Fiducial Markers to Guide Pancreas Surgery. J Clin Gastroenterol. 2024 Oct 1;58(9):931-936. doi: 10.1097/MCG.0000000000001952.
PubMed 38112649
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Endoscopic Ultrasound Guided Coil Placement to Facilitate Intraoperative Assessment of Pancreas Tumors
- ClinicalTrials.gov ID
- NCT02863783
- Acronym / sponsor ID
- HS-16-00032
- Conditions
- Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- 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.
RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been developed which enables fiducial coils to be placed at the precise site of biopsy.
INTERVENTION: At time of EUS guided biopsy the fine needle fiducial device will be used to place fiducials in the tumor. During surgery we will assess whether it improves tumor visualization.
OBJECTIVES: We aim to determine the feasibility to use EUS guided fiducials placement to mark pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization during pancreas surgery.
STUDY POPULATION: Patients with pancreas adenocarcinoma or neuroendocrine lesions.
STUDY ENDPOINTS: The main outcome will be to assess whether the coil may be successfully placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and ANALYSIS: Patients will be assessed at the time of EUS and surgery. This is a pilot analysis with the intention to assess feasibility and to gather data to power larger trials.
Detailed description
Minimally invasive pancreatic surgery diminishes the morbidity and mortality of the potentially curative procedures. However precise targeting of small adenocarcinomas and neuroendocrine tumors is challenging.
Given safety, precision, and ease EUS guided pancreatic fiducial placement has emerged as a favored method to mark tumors for radiation therapy. The experimental aspect of this procedure is gauge whether EUS guided fiducial placement improves the intraoperative assessment of pancreas tumors. We will use the recently introduced (FDA approved) Beacon EUS guided fiducial system to perform placement. The fiducial will not alter the surgical plan in this study. However, the relative ability to detect the marker during standard pancreatic surgery will help to inform whether this strategy may be used in improve future approaches to pancreas surgery.
The study will be a prospective trial. All EUS will be performed as part of standard clinical care.
Conventional EUS+FNA The linear array echoendoscope will be used to identify the pancreas adenocarcinoma and neuroendocrine tumors. The Beacon EUS system/delivery sheath will be passed and fine needle aspiration performed to confirm cytology. This is required for standard clinical care. The delivery sheath will be left in place. The cytologist will perform bedside interpretation as is standard clinical care.
EUS guided coil injection If adenocarcinoma or neuroendocrine tumor is confirmed by fine needle aspiration the fine needle fiducial accessory will be passed through the delivery sheath (whose position on the tumor is now "biopsy confirmed" and 1-3 fiducials (coil type) will be introduced into the lesion. This process will be guided by EUS which is being performed for standard clinical care. Fluoroscopy not be utilized.
Pancreas Surgery: At time of surgery the experimental component is that it will be gauged whether the fiducial impacts the ability to assess the tumor relative to lesions of comparable size. Whether the fiducial improves or does not improve assessment will be scaled on a 1-10 scale where 5 is the standard ease of detection of similarly sized tumors (without fiducials) based on the attending surgeon's experience.
However, the fiducial will not be used to target the lesion or alter the surgical plan. The surgical plan will be based on preoperative clinical imaging, intraoperative findings, and intraoperative ultrasound (standard clinical care). The research coordinator will be present during surgery to facilitate timely acquisition of data. In some cases patient are deemed to not be resection candidates at the time of surgery if for example unexpected metastasis are found. The EUS guided fiducial placement will have no bearing on whether resection is done or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiducial Placement | Experimental | Device: EUS with FiducialEUS with Fiducial Placement into Tumor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing endoscopic ultrasound for preoperative evaluation before planned pancreatic surgery for suspected adenocarcinoma and neuroendocrine tumors will be eligible. Rapid onsite evaluation is performed for all pancreas EUS as part of standard procedures. In this process the cytologist examines the cells and makes a determination whether the aspirate contains malignant or benign tissue. Fiducials will only be placed if cytologic confirmation of malignancy at the site is obtained.
- Tumors of sizes 5mm-4cm will be eligible as there may be benefit in marking small tumors given difficulty finding them with intraoperative ultrasound. Moderately large pancreas tumors may also cause fibrosis which makes identification for resection difficult. Coil placement in regions of cytologically confirmed malignant cells may be helpful. Fiducial markers will only be placed if the initial evaluation (abdominal computed tomography or magnetic resonance imaging) indicates resectability. If finding of nonresectability (i.e. liver metastasis) are seen on EUS then fiducials will not be placed.
Key exclusion criteria (1 listed)
- 1) Patients with INR >1.5 2) Platelet county <100 3) Metal allergy 4) Pregnant 5) <18 years of age 6) Patients with pancreatic lymphoma will also be excluded as this is treated with chemotherapy.
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 |
|---|---|---|
| EUS with FiducialEUS will be used to place fiducial into pancreas tumor at time of biopsy | Device | Fiducial Placement |
Primary outcome
The Proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted
Time frame: 3 months
the primary outcome will be to assess whether the coil may be successfully placed. This will be reported as the proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted.
Relative Ease of Detection of the Tumor with Fiducial
Time frame: 3 months
A co-primary outcome will be to assess whether the coil may detected at time of surgery. The proportion of patients in whom the fiducial may be easily detected will also be reported. The relative ease of detection of the tumor (with fiducial) will be compared to the ease of detection of similar sized tumors without the fiducial. A QUESTIONNAIRE will be used in which each of detection by the attending surgeon will be recorded with 5 being each of detection of similar (histology/size) tumor without fiducial.
1 secondary outcome
Pancreatitis, abdominal pain, infection, bleeding following placement.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 20189509Park WG, Yan BM, Schellenberg D, Kim J, Chang DT, Koong A, Patalano C, Van Dam J. EUS-guided gold fiducial insertion for image-guided radiation therapy of pancreatic cancer: 50 successful cases without fluoroscopy. Gastrointest Endosc. 2010 Mar;71(3):513-8. doi: 10.1016/j.gie.2009.10.030.
- Background: PubMed 18599051Farrell JJ, Sherrod A, Parekh D. EUS-guided fine-needle tattooing for preoperative localization of early pancreatic adenocarcinoma. Gastrointest Endosc. 2009 Jan;69(1):176-7. doi: 10.1016/j.gie.2008.03.1069. Epub 2008 Jul 2. No abstract available.
- Background: PubMed 21034909Lennon AM, Newman N, Makary MA, Edil BH, Shin EJ, Khashab MA, Hruban RH, Wolfgang CL, Schulick RD, Giday S, Canto MI. EUS-guided tattooing before laparoscopic distal pancreatic resection (with video). Gastrointest Endosc. 2010 Nov;72(5):1089-94. doi: 10.1016/j.gie.2010.07.023.
- Derived from this study: PubMed 38112649Chang PW, Sadik J, Sahakian AB, Kankotia R, Ko C, Serna J, Rodriguez A, Lee H, Kulkarni S, Genyk Y, Sheikh M, Buxbaum JL. A Preliminary Controlled Trial of Endoscopic Ultrasound-guided Fiducial Markers to Guide Pancreas Surgery. J Clin Gastroenterol. 2024 Oct 1;58(9):931-936. doi: 10.1097/MCG.0000000000001952.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS with Fiducial in people with Pancreatic Neoplasms, run by University of Southern California 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted (time frame: 3 months). 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 NCT02863783, which also lists 4 linked publications.
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 6 Mar 2023.