Clinical trial · Interventional
Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management
Drain Amylase Levels After Pancreatoduodenectomy. Validations of New cut-of for the Stratification of Postoperative Complications, Surgical Drains Management and Use of Postoperative Abdominal CT: (The DALCUT) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pancreatic fistula (PF) represents the Achille's heel of pancreatic surgery and is the main cause of postoperative morbidity since it can determine the onset of others complications such as abdominal abscesses, surgical wound infections, sepsis and bleeding, that can sometimes be fatal. During a previous study conducted at the University Campus Bio-Medico of Rome, Department of General Surgery there were identified cut-offs of amylase levels on the abdominal drainage fluid dosed in I postoperative day (POD1) and III postoperative day (POD3) which can significantly predict PF and in particular clinically relevant fistulas as well as abdominal collections and biliary fistulas, if related to some specific findings of the abdominal CT routine performed in POD3. The aim of this research project is to validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant PF and to validate the use of abdomen CT without contrast in POD3 in patients with increased risk of biliary fistula.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Fistula | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical Drains Management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drain removal
- description
- Patients that fulfill criteria for surgical drains removal
- interventionNames
- Procedure: Surgical Drains Management
Primary outcomes (2)
- measure
- Validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant FP
- timeFrame
- From postoperative day 1 to postoperative day 90
- description
- The management of drainages and the execution of the abdomen CT scan in Postoperative day 3 will be managed on the basis of the outcome of the assay of amylase levels performed on fluid collected by surgical drains. This evaluation will be performed each day in the first three postoperative days or until drains removal.
- measure
- Validate the ability of the diameter (in cm) of abdominal collection detected during the contrast-free abdomen CT in POD3 to predict risk of biliary fistula
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 years old * acquisition of informed consent for surgery and for inclusion in the study; * elective open or laparoscopic PD Exclusion Criteria: * age \<to 18 years; * absence of informed consent for inclusion in the study; * Emergency surgery; * other pancreatic resections (not PD).
References
Publications (0)
Data not yet available