An interventional study of No Touch (NT) and Superior Mesenteric Artery First (SMA) in Pancreatic Tumor, Periampullary Carcinoma Resectable and Circulating Tumor Cells, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Not applicable, Interventional, and Other
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.
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:
Subsequently, the quantified levels of CTCs will be correlated with the occurrence of local tumor recurrence, metastasis development and patient patient survival.
Exclusion Criteria:
Pancreatic and Periampullary Tumors resection by no-touch technique
Procedure: No Touch (NT)
Pancreatic and Periampullary Tumors resection by superior Mesenteric Artery First technique
Procedure: Superior Mesenteric Artery First (SMA)
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.
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).
Circulating tumor cells (CTC´s)
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
Time frame: 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
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)
Time frame: From the day of surgery to 3 years of follow-up
Metastasis
Presence (YES or NO) compatible images of metastasis
Time frame: From the day of surgery to 3 years of follow-up
Patient survival
Death (YES OR NO): number of patients dying during study
Time frame: From the day of surgery to 3 years of follow-up
Morbidity
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)
Time frame: From the day of surgery up to 6 weeks of follow-up
Plan to share: Yes — Yes. Anonymized data for individual participant data (IPD) is planned to be shared with all participants within 6 months of data completion
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla