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Pancreatic and Periampullary Tumors resection by no-touch technique

Pancreatic and Periampullary Tumors resection by superior Mesenteric Artery First technique

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.

No Touch (NT)

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).

Superior Mesenteric Artery First (SMA)

Francisco Javier Padillo Ruiz, PhD

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:

* 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.

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

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

Yes. Anonymized data for individual participant data (IPD) is planned to be shared with all participants within 6 months of data completion

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

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)

Presence (YES or NO) compatible images of metastasis

Death (YES OR NO): number of patients dying during study

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors	NCT03340844	Pancreatic Tumo... Periampullary C... Circulating Tum... Metastasis	No Touch (NT) Superior Mesent...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors	NCT03340844	Pancreatic Tumo... Periampullary C... Circulating Tum... Metastasis	No Touch (NT) Superior Mesent...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Spots Global Cancer Trial Database for no touch (nt)