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

Not Applicable

Completed

• Conditions: Pancreatic Tumor; Periampullary Carcinoma Resectable; Metastasis; Circulating Tumor Cells
• Interventions: Procedure: No Touch (NT); Procedure: Superior Mesenteric Artery First (SMA)

• Registration Number: NCT03340844
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-14
• Study Start: 2017-12-15
• Status Verified: 2021-10
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Touch (NT)	No Touch (NT)	Pancreatic and Periampullary Tumors resection by no-touch technique
Superior Mesenteric Artery First (SMA)	Superior Mesenteric Artery First (SMA)	Pancreatic and Periampullary Tumors resection by superior Mesenteric Artery First technique

Primary Outcome Measures

Name	Time	Method
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)
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
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain