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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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