deltatrials
Completed OBSERVATIONAL NCT02115022

EUS vs. MDCT in Pancreatic Malignancy (EUSPACT)

Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?

Sponsor: Clinical Hospital Colentina

Updated 10 times since 2017 Last updated: Apr 26, 2020 Started: Jul 31, 2014 Primary completion: Jan 31, 2018 Completion: Feb 28, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Resectable Pancreatic Cancer, this trial is completed. The trial is conducted by Clinical Hospital Colentina and has accumulated 10 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

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...

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).

Status Flow

~Jan 2017 – ~Mar 2018 · 14 months · monthly snapshotRecruiting~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotCompleted~Jul 2018 – ~May 2020 · 22 months · monthly snapshotCompleted~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed

  2. Sep 2024 — Sep 2025 [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2021 — Jul 2024 [monthly]

    Completed

  5. May 2020 — Jan 2021 [monthly]

    Completed

Show 5 earlier versions
  1. Jul 2018 — May 2020 [monthly]

    Completed

  2. Jun 2018 — Jul 2018 [monthly]

    Completed

  3. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  4. Mar 2018 — Apr 2018 [monthly]

    Completed NA

    Status: RecruitingCompleted

  5. Jan 2017 — Mar 2018 [monthly]

    Recruiting NA

    First recorded

Jul 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Clinical Hospital Colentina
  • Institutul Clinic Fundeni
  • Iuliu Hatieganu University of Medicine and Pharmacy
  • University of Medicine and Pharmacy Craiova
Data source: Clinical Hospital Colentina

For direct contact, visit the study record on ClinicalTrials.gov .