Published online May 26, 2022. doi: 10.12998/wjcc.v10.i15.4836
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
Postoperative pancreatic fistula (POPF) is the most fearful complication after pancreatic surgery and can lead to severe postoperative complications such as surgical site infections, sepsis and bleeding. A previous study which identified cut-offs of drains amylase levels (DALs) determined on postoperative day (POD) 1 and POD3, was able to significantly predict POPF, abdominal collections and biliary fistulas, when related to specific findings detected at the abdominal computerized tomography (CT) scan routinely performed on POD3.
To validate the cut-offs of DALs in POD1 and POD3, established during the previous study, to assess the risk of clinically relevant POPF and confirm the usefulness of abdominal CT scan on POD3 in patients at increased risk of abdominal collection.
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 three postoperative days.
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. Drains could be removed in POD3 in case of POD1 DALs < 666 U/L and POD3 DALs < 207 U/L. 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.
The results of this trial will contribute to a better knowledge of POPF and management of surgical drains.
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.