NCT03340844

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

Role of Circulating Tumor Cells (CTC´s) Spread During Pancreaticoduodenectomy in Metastasis and Survival Rates in Patients With Pancreatic and Periampullary Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Tumor
• Periampullary Carcinoma Resectable
• Circulating Tumor Cells
• Metastasis

Interventions

Type	Name	Description
PROCEDURE	No 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.
PROCEDURE	Superior 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).

Timeline

• Start date: 2017-12-15
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2017-11-14
• Last updated: 2024-05-14

Locations

1 site across 1 country: Spain