Clinical trial NCT03340844: Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors
Official title: Role of Circulating Tumor Cells (CTC´s) Spread During Pancreaticoduodenectomy in Metastasis and Survival Rates in Patients With Pancreatic and Periampullary Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Tumor
Periampullary Carcinoma Resectable
Circulating Tumor Cells
Metastasis
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized (1:1) to 2 study groups according to duodenopancreatectomy surgical approach: "No-Touch group" (NT) or "Artery First group" (SMA) in patients with pancreatic and periampullary tumors, to evaluated circulating tumor cells (CTCs) levels during the surgery. Sample size = 86
Primary purpose: OTHER

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 cephalic duodenopancreatectomy in patients with pancreatic and periampullary tumors.

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 the best option in relation to local recurrence, metastasis and survival.

In the study, patients will be randomized into two study groups with pancreatic and periampullary tumors undergoing cephalic pancreatectomy (NT) vs initial approach by superior mesenteric artery (SMA).

The measurement of circulating tumor cells (CTCs) allows to assess the degree of cellular dissemination due to surgical manipulation.CTCs will be evaluated during surgery (nº CTCs / mL blood). To do this, a maximum of 4 blood samples from the portal vein will be performed, in each study group according to the following scheme:

* NT group: basal (at the beginning of surgery), portal vein pancreatic detachment, postresection (NT2) and before closure (NT3).
* SMA group: basal (at the beginning of surgery), after Kocher maneuver and SMA dissection, postresection, before closure.

Subsequently, the quantified levels of CTCs will be correlated with the occurrence of local tumor recurrence, metastasis development and patient patient survival.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

1. Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
2. Patients with neuroendocrine pancreatic tumors or cystic tumors.
3. Patients in whom tumor resection is not finally achieved because it shows intraoperatively that the tumor is locally advanced and unresectable.
4. Patients with macroscopic residual tumor (R2).
5. High-risk patients with severe pathology (ASA IV) according to the American Association of Anesthesiologists.
6. Patients receiving neoadjuvant therapy
7. Patients in whom the intraoperative pathological anatomy indicates borders of pancreatic resection affected

Primary outcomes:
measure: 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
measure: Local tumor recurrence
timeFrame: From the day of surgery to 3 years of follow-up
measure: Metastasis
timeFrame: From the day of surgery to 3 years of follow-up
measure: Patient survival
timeFrame: From the day of surgery to 3 years of follow-up
Secondary outcomes:
measure: Morbidity
timeFrame: From the day of surgery up to 6 weeks of follow-up
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Francisco Javier Padillo Ruiz, PhD
role: PRINCIPAL_INVESTIGATOR
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