Resectable Pancreatic CancerEUSPACTNCT02115022
EUS vs. MDCT in Pancreatic Malignancy
An observational study of Resectable Pancreatic Cancer, run by Clinical Hospital Colentina at 5 sites in Romania.
Trial summary
Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Cancer
- How many people
- 45 participants
- Where
- 5 sitesRomania
- Study dates
- Jul 2014to Feb 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent.
Who may be able to join
- adult (≥ 18 years of age) patients;
- the presence of a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT);
- patients fit and willing to undergo surgery with a curative (R0) intent;
- sign of the informed consent.
Who cannot join
- the presence of significant co-morbidities that contraindicate pancreatic resection;
- previous neo-adjuvant oncologic therapy;
- distant metastases;
- lack of discernment;
- refusal to sign the informed consent..
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Romania5 sites
University Military Hospital
Bucharest, 010825
Gastroenterology Department, Clinical Hospital Colentina
Bucharest, 020125
Fundeni Clinical Institute
Bucharest
Iuliu Hatieganu University of Medicine
Cluj-Napoca
Research Center in Gastroenterogy and Hepatology
Craiova, Dolj, 200638
About this study
Official title: Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?
Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. As a matter of fact, pancreatic cancer staging is discussed controversially due to conflicting evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the role of EUS and EUS-guided FNA varies among treatment centers.
The present study is designed to better define the role of EUS in predicting resectability, as compared to high resolution cross-sectional imaging.
Read the detailed description
Registry procedures:
- HIGH-RESOLUTION PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT) SCAN EXAMINATION: performed on at least 16-section multi-detector row (MD) CT and reviewed using multi-planar reconstructions, with images obtained following the oral administration of water and pancreatic protocol intravenous iopamidol, with images acquired in the pancreatic and portal venous phases of contrast enhancement, reconstructed as thin slice (at 1 mm - pancreatic phase or 2 mm - portal venous phase increments).
- EUS EXAMINATION: performed within 2 weeks of the MDCT, aiming visualization of the pancreas, main surrounding vascular structures, celiac and mediastinal lymph nodes, liver and left adrenal gland, with EUS-FNA performed at the discretion of the investigator/examiner to confirm/exclude metastases and for the confirmation of malignancy in the primary tumor. Patients confirmed by EUS as having distant metastases are to be deferred from the planned surgical intervention.
- SURGICAL INTERVENTION: aiming to provide curative intent (R0) resection.
- HISTOPATHOLOGICAL POSTOPERATIVE STAGING: with evaluation of loco-regional invasiveness and degree of complete surgical resection (R0/R1).
- FOLLOW-UP OF PATIENTS: with phone-calls on an every 6 month basis, for up to 2 years, retaining the following data: survival (or not), date of decease and its direct cause (if applicable), the presence of tumor recurrence (or not).
- Conditions
- Resectable Pancreatic Cancer
- Keywords
- pancreatic cancer, resectability, endosonography (EUS), multidetection computer tomography (MDCT), staging
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Potentially resectable pancreatic cancer | Patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staging capability of each study procedure
Each imaging test (MDCT and EUS) and findings at or after surgery are to be judged on their ability to provide descriptions of the primary tumor's size, location, relationship to vessels - using the terms abutment (≤180º of contact) and encasement (>180º of contact), vessel occlusion, variant vascular anatomy, a grade regarding local tumor resectability (resectable, borderline resectable, or locally advanced; R0 or R1 resection), and extent and location of extrapancreatic disease.
Measured: Up to 2 weeks, depending on the time of the surgical intervention
Secondary outcomes (2)
Side-effects related to the EUS examination
Each patient will be monitored for 24 hours after the EUS examination to identify possible early complications of the procedure
Measured: Monitored for 24 hours after EUS
Patient survival time, and tumor recurrence-free survival
Each patient is going to be followed-up for up to 2 years after the surgical intervention an an every-6 month basis, in order to identify events such as death or tumor recurrence.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy Craiova, Iuliu Hatieganu University of Medicine and Pharmacy, Institutul Clinic Fundeni
- Responsible party
- Principal investigator, Mihai Rimbas, Clinical Hospital Colentina
- Investigators
- Mihai Rimbas, MD, PhD, Principal investigator, Clinical Hospital Colentina, Carol Davila University of Medicine and PharmacyCristian R Baicus, Professor, Study chair, Clinical Hospital Colentina, Carol Davila University of Medicine and PharmacyAdrian Saftoiu, Professor, Study director, Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115022
- Sponsor's protocol ID
- Col-gastro 5
- Acronym
- EUSPACT
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2014
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?
- ClinicalTrials.gov ID
- NCT02115022
- Acronym / sponsor ID
- EUSPACT / Col-gastro 5
- Conditions
- Resectable Pancreatic Cancer
- Keywords
- pancreatic cancer, resectability, endosonography (EUS), multidetection computer tomography (MDCT), staging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy Craiova, Iuliu Hatieganu University of Medicine and Pharmacy, Institutul Clinic Fundeni
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Apr 2014 (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.
Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. As a matter of fact, pancreatic cancer staging is discussed controversially due to conflicting evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the role of EUS and EUS-guided FNA varies among treatment centers.
The present study is designed to better define the role of EUS in predicting resectability, as compared to high resolution cross-sectional imaging.
Detailed description
Registry procedures:
- HIGH-RESOLUTION PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT) SCAN EXAMINATION: performed on at least 16-section multi-detector row (MD) CT and reviewed using multi-planar reconstructions, with images obtained following the oral administration of water and pancreatic protocol intravenous iopamidol, with images acquired in the pancreatic and portal venous phases of contrast enhancement, reconstructed as thin slice (at 1 mm - pancreatic phase or 2 mm - portal venous phase increments).
- EUS EXAMINATION: performed within 2 weeks of the MDCT, aiming visualization of the pancreas, main surrounding vascular structures, celiac and mediastinal lymph nodes, liver and left adrenal gland, with EUS-FNA performed at the discretion of the investigator/examiner to confirm/exclude metastases and for the confirmation of malignancy in the primary tumor. Patients confirmed by EUS as having distant metastases are to be deferred from the planned surgical intervention.
- SURGICAL INTERVENTION: aiming to provide curative intent (R0) resection.
- HISTOPATHOLOGICAL POSTOPERATIVE STAGING: with evaluation of loco-regional invasiveness and degree of complete surgical resection (R0/R1).
- FOLLOW-UP OF PATIENTS: with phone-calls on an every 6 month basis, for up to 2 years, retaining the following data: survival (or not), date of decease and its direct cause (if applicable), the presence of tumor recurrence (or not).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potentially resectable pancreatic cancer | – | –Patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent.
Key inclusion criteria (4 listed)
- adult (≥ 18 years of age) patients;
- the presence of a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT);
- patients fit and willing to undergo surgery with a curative (R0) intent;
- sign of the informed consent.
Key exclusion criteria (5 listed)
- the presence of significant co-morbidities that contraindicate pancreatic resection;
- previous neo-adjuvant oncologic therapy;
- distant metastases;
- lack of discernment;
- refusal to sign the informed consent..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Staging capability of each study procedure
Time frame: Up to 2 weeks, depending on the time of the surgical intervention
Each imaging test (MDCT and EUS) and findings at or after surgery are to be judged on their ability to provide descriptions of the primary tumor's size, location, relationship to vessels - using the terms abutment (≤180º of contact) and encasement (>180º of contact), vessel occlusion, variant vascular anatomy, a grade regarding local tumor resectability (resectable, borderline resectable, or locally advanced; R0 or R1 resection), and extent and location of extrapancreatic disease.
2 secondary outcomes
Side-effects related to the EUS examination
Time frame: Monitored for 24 hours after EUS
Patient survival time, and tumor recurrence-free survival
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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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.
Mihai Rimbas, MD, PhD principal investigator
Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy
Cristian R Baicus, Professor study chair
Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy
Adrian Saftoiu, Professor study director
Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Pancreatic Cancer, run by Clinical Hospital Colentina at 5 sites in Romania.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Staging capability of each study procedure (time frame: Up to 2 weeks, depending on the time of the surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020; AzTrials last refreshed its copy on 4 Nov 2026.