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
ARTICLE HIGHLIGHTS
Research background

Postoperative pancreatic fistula (POPF) still remains the main complication after pancreatic surgery as it can lead to several and even life-threatening postoperative complications (e.g., surgical site infections, sepsis and bleeding).

Research motivation

A previous study allowed to identify cut-offs of drains amylase levels (DALs) determined on postoperative day (POD) 1 and POD3, able to significantly predict POPF, abdominal collections and biliary leaks, when related to defined findings identified at the abdominal computerized tomography (CT) scan routinely executed on POD3.

Research objectives

The aim of this trial is to validate the cut-offs of DALs in POD1 and POD3, established during the previous study, evaluating the risk of clinically relevant POPF and confirm the usefulness of abdominal CT scan on POD3 in patients at increased risk of abdominal collection.

Research methods

The DALCUT trial is an interventional prospective study. All patients who will undergo pancreatoduodenectomy (PD) for periampullary neoplasms will be considered eligible. All patients will receive clinical staging and, if eligible for surgery, will undergo routine preoperative evaluation. After the PD, daily DALs will be evaluated from POD1. Drains removal and possible requirement of abdominal CT scans in POD3 will be managed on the basis of the outcome of DALs in the first 3 PODs.

Research results

In POD3 drains removal is feasible in presence of levels of drains amylases < 666 U/L in POD1 and < 207 U/L in POD3. In case of POD3 DALs ≥ 252, abdominal CT scan will be performed in POD3 to identify abdominal collections ≥ 5 cm. In this latter category of patients, drains could be maintained beyond POD3.

Research conclusions

This prospective study could validate the role of DALs in the management of surgical drains and in assessing the risk or relevant complications after PD.

Research perspectives

The results of this trial will contribute to a better knowledge of POPF and management of surgical drains.