Caputo Damiano, Coppola Alessandro, La Vaccara Vincenzo, Passa Roberto, Carbone Ludovico, Ciccozzi Massimo, Angeletti Silvia, Coppola Roberto
Department of Surgery, University Campus Bio-Medico of Rome, Rome 00128, Italy.
Unit of Medical Statistic and Molecular Epidemiology, University Campus Bio-Medico of Rome, Rome 00128, Italy.
World J Clin Cases. 2022 May 26;10(15):4836-4842. doi: 10.12998/wjcc.v10.i15.4836.
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.
术后胰瘘（POPF）是胰腺手术后最可怕的并发症，可导致严重的术后并发症，如手术部位感染、脓毒症和出血。一项先前的研究确定了术后第1天（POD1）和第3天（POD3）引流液淀粉酶水平（DALs）的临界值，当与POD3常规进行的腹部计算机断层扫描（CT）检查发现的特定结果相关时，该研究能够显著预测POPF、腹腔积液和胆瘘。
验证先前研究中确定的POD1和POD3时DALs的临界值，以评估临床相关POPF的风险，并确认POD3时腹部CT扫描对腹腔积液风险增加患者的有用性。
DALCUT试验是一项前瞻性干预研究。所有因壶腹周围肿瘤接受胰十二指肠切除术（PD）的患者均被视为符合条件。所有患者将接受临床分期，若符合手术条件，将进行常规术前评估。PD术后，从POD1开始每日评估DALs。POD3时引流管的拔除及腹部CT扫描的可能需求将根据术后前三天DALs的结果进行处理。
这项前瞻性研究可以验证DALs在手术引流管理以及评估PD术后风险或相关并发症方面的作用。如果POD1时DALs<666 U/L且POD3时DALs<207 U/L，则可在POD3时拔除引流管。如果POD3时DALs≥252，则将在POD3时进行腹部CT扫描以识别≥5 cm的腹腔积液。在这后一类患者中，引流管可保留至POD3之后。
该试验结果将有助于更好地了解POPF及手术引流的管理。
