CompletedNot Applicable

Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors

Spain86 participantsStarted 2017-12-15

Plain-language 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 cephalic duodenopancreatectomy in patients with pancreatic and periampullary tumors.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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

What they're measuring

Circulating tumor cells (CTC´s)

Timeframe: During the surgery: at the beginning of surgery, immediately after disconnecting the pancreas from the portal vein, just at the moment the pancreatic resection ends and before the skin closed

Local tumor recurrence

Timeframe: From the day of surgery to 3 years of follow-up

Metastasis

Timeframe: From the day of surgery to 3 years of follow-up

Patient survival

Timeframe: From the day of surgery to 3 years of follow-up

Trial details

NCT IDNCT03340844

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

View on ClinicalTrials.gov More Pancreatic Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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

What they're measuring

Circulating tumor cells (CTC´s)

Local tumor recurrence

Timeframe: From the day of surgery to 3 years of follow-up

Metastasis

Timeframe: From the day of surgery to 3 years of follow-up

Patient survival

Timeframe: From the day of surgery to 3 years of follow-up