Status:
COMPLETED
Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Pancreatic Tumor
Periampullary Carcinoma Resectable
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This multicentre, prospective and randomized study aims(1:1) to compare the rate of recurrence, metastasis and survival according to the levels of intraoperative circulating tumor cells (CTCs) during ...
Detailed Description
Cephalic duodenopancreatectomy is the technique indicated for patients with pancreatic head carcinoma and periampullar tumors. There are different technical variants, it is not standardized what is t...
Eligibility Criteria
Inclusion
- 1\. Patients older than 18 years, with adenocarcinomas of the pancreas and potentially resectable periampullary tumors by cephalic duodenopancreatectomy or total duodenopancreatectomy indicated intraoperatively for technical reasons, who voluntarily agree to participate in the study and sign informed consent
Exclusion
- Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
- Patients with neuroendocrine pancreatic tumors or cystic tumors.
- Patients in whom tumor resection is not finally achieved because it shows intraoperatively that the tumor is locally advanced and unresectable.
- Patients with macroscopic residual tumor (R2).
- High-risk patients with severe pathology (ASA IV) according to the American Association of Anesthesiologists.
- Patients receiving neoadjuvant therapy
- Patients in whom the intraoperative pathological anatomy indicates borders of pancreatic resection affected
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03340844
Start Date
December 15 2017
End Date
July 15 2023
Last Update
May 14 2024
Active Locations (1)
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1
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013