Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. May 26, 2022; 10(15): 4836-4842
Published online May 26, 2022. doi: 10.12998/wjcc.v10.i15.4836
Validations of new cut-offs for surgical drains management and use of computerized tomography scan after pancreatoduodenectomy: The DALCUT trial
Damiano Caputo, Alessandro Coppola, Vincenzo La Vaccara, Roberto Passa, Ludovico Carbone, Massimo Ciccozzi, Silvia Angeletti, Roberto Coppola
Damiano Caputo, Alessandro Coppola, Vincenzo La Vaccara, Roberto Passa, Ludovico Carbone, Roberto Coppola, Department of Surgery, University Campus Bio-Medico of Rome, Rome 00128, Italy
Massimo Ciccozzi, Unit of Medical Statistic and Molecular Epidemiology, University Campus Bio-Medico of Rome, Rome 00128, Italy
Silvia Angeletti, Unit of Clinical Laboratory Science, University Campus Bio-Medico of Rome, Rome 00128, Italy
Author contributions: Caputo D, Ciccozzi M, Angeletti S, Coppola A and Coppola R contributed to the conception and design of the work; Coppola A, Passa R, Carbone L and La Vaccara V collected data; Caputo D, Coppola A, Angeletti S, Ciccozzi M, Carbone L and La Vaccara V were involved in data analysis and interpretation; Caputo D, Coppola A, La Vaccara V, Passa R and Carbone L contributed to the drafting of the article; Caputo D, Coppola A, La Vaccara V, Coppola R and Angeletti S contributed to the critical revision of the article; and all authors were involved in the final approval of the version to be published.
Institutional review board statement: The study was reviewed and approved by the Ethical Committee of Università Campus Biomedico di roma. Institutional Review Board (Approval No. 24/20 PAR ComEt CBM).
Clinical trial registration statement: This registration policy applies to registry trials. This study is registered at https://clinicaltrials.gov/ct2/show/NCT04380506.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: There is no conflict of interest to declare.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Damiano Caputo, FACS, MD, Associate Professor, Doctor, Department of Surgery, University Campus Bio-Medico of Rome, Via Alvaro del Portillo 200, Rome 00128, Italy. d.caputo@unicampus.it
Received: April 26, 2021
Peer-review started: April 26, 2021
First decision: July 27, 2021
Revised: August 3, 2021
Accepted: April 21, 2022
Article in press: April 21, 2022
Published online: May 26, 2022
Processing time: 392 Days and 19.3 Hours
Core Tip

Core Tip: Nowadays, postoperative pancreatic fistula (POPF) is the most dreadful complication after pancreatic surgery. POPF can lead to severe postoperative complications such as surgical site infections, sepsis and bleeding. The DALCUT trial is an interventional prospective study with the aim to validate cut-offs of the drains amylase levels in postoperative day (POD) 1 and POD3, found during the previous study, to assess the risk of clinically relevant POPF and confirm the usefulness of abdomen computerized tomography scan on POD3 in patients at increased risk of postoperative abdominal collections.