Circulating Tumor Cells, Metastasis, Pancreatic Tumor, Periampullary Carcinoma Resectable
Conditions
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.
Interventions
PROCEDURENo Touch (NT)
Tumor resection by No-touch technique: dissection of hepatic hilum, dissection of superior mesenteric vein (SMV) in caudal aspect of pancreas, section of antrum, pancreatic neck section. Section-ligation of veins of duodenopancreatectomy part of SMV and portal. Then Kocher-uncrossing maneuver of the jejunal loop and final section of the retro-portal (back of the portal vein) blade.
PROCEDURESuperior Mesenteric Artery First (SMA)
Tumor resection by SMA technique: Kocher maneuver extends to the left renal vein (LRV). Dissection above the LRV of the SMA (refer to vessel-loop). Then, SMA will be identified on the caudal side of the pancreas (mesenterial root) and progressive dissection until its origin in the aorta artery (previously referenced with vessel loop).
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating tumor cells (CTC´s) | 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 | Change in the concentration of circulating tumor cells (CTCs) levels (nº CTCs/ mL blood) during the surgery, 4 blood samples will be taken from the portal vein |
| Local tumor recurrence | From the day of surgery to 3 years of follow-up | Presence (YES or NO) compatible images of local tumor recurrence Valid imaging tests of presence or absence can be checked by: computerized tomography (CT) or magnetic resonance (NMR) |
| Metastasis | From the day of surgery to 3 years of follow-up | Presence (YES or NO) compatible images of metastasis |
| Patient survival | From the day of surgery to 3 years of follow-up | Death (YES OR NO): number of patients dying during study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | From the day of surgery up to 6 weeks of follow-up | The complications evaluation and their severity will be based on the classification of Dindo-Clavien and the definitions of the International Study Group of Pancreatic Surgery (ISGPS). * Pancreatic fistula: Presence (yes or no) and degree (A, B, C) * Delayed gastric emptying: Presence (yes or no) and degree (A, B, C) * Hemorrhage: Presence (yes or no) and degree (A, B, C) |
Countries
Spain
Outcome results
None listed