Pancreas Cancer Clinical Trial
Official title:
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
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.
Pancreatic Fistula (PF) remains the main complication following pancreatic surgery with an
incidence described in up to 45% of cases, even in high volume centers. It can determine the
onset of other complications such as abdominal abscesses, surgical wound infections, sepsis
and bleeding, sometimes fatal. In addition, the economic impact due to the extension of
hospital stay and the management costs of the PF are not of secondary importance.
The International Study Group on Pancreatic Fistula (ISGFP) has standardized the definition
of PF identifying it as "the leak from a surgical or percutaneous drainage of any measurable
quantity of fluid, starting from the third postoperative day (POD3), with an amylase content
three times higher than the upper normal limit of serum amylases. " However, according to
this definition, all patients who satisfy this condition, even in the absence of any clinical
signs or symptoms, are defined as suffering from pancreatic fistula.
To overcome this, a three grades classification system of PF was introduced, based on the
clinical impact:
- Grade A: It is biochemical fistula; No intervention needed, not significant change of
the post-operative hospital stay.
- Grade B: it requires an extension of the post-operative hospital stay, the permanence of
surgical drains, the possible positioning of further drainages under radiological guide,
antibiotic therapy and the use of artificial, enteral or parenteral nutrition;
- grade C: re-surgery is needed. Grade B and C represent clinically relevant fistulas. It
is therefore evident that a correct definition of PF and its grade (A, B, C) can only be
formulated "a posteriori".
However, considering the high prognostic impact of PF, it is needful to identify risk factors
and diagnostic tools capable of stratifying patients at risk of pancreatic fistula and reach
an early diagnosis in order to plan better plan both the treatment of it and the
complications that may arise.
Many authors assume that the main predictive factor of PF is represented by the level of
amylases in the abdominal drainage fluid, at different cut-offs and on different
postoperative days. Others assume that abdominal drainage itself determines the development
of PF and other complications.
Molinari has shown that a level of amylase in the abdominal drainage fluid <5000 IU / L in
POD1 identifies a subgroup of patients at low risk of PF in which abdominal drainage is
unfavorable to maintain. In Molinari's work, however, patients with PF grade A were also
considered.
In his experience, Fong has identified a high-risk of PF subgroup in patients underwent DCP
with an amylase level in abdominal drainage fluid > 600 IU / L in POD1. The author therefore
proposed the immediate removal of abdominal drainage in patients considered low risk.
One of the most consistent bias of the Fong study is that in some patients there was an
intrapancreatic drainage connected to the outside. Recently, Seykora has shown how in
patients underwent DCP it is possible to use different amylase level cutoffs on drainage
fluid in POD1, POD3 and POD5 in order to predict the clinically relevant PF risk and modulate
the management of surgical drainages.
One of the limitations of the cut-offs identified by Seykora is represented by the fact that
they have been identified considering their negative predictive value rather than their
positive predictive value.
In a study recently conducted at Campus Bio-Medico University of Rome, Caputo confirmed that
the dosage of amylase on the abdominal drainage fluid represents the most important
clinically relevant predictor of PF and has confirmed, as underlined by Seykora, that the
management of abdominal drainage is necessarily a dynamic process conditioned mainly by the
serial dosage of amylases on drainage liquid (POD1-3).
Furthermore, in the Caputo's work, cut-offs of amylases on the abdominal drainage liquid (>
666 IU / L in POD1 and> 252 IU / L in POD3) have been identified as able to predict more than
80% of the clinically relevant PF. It has also been shown that the value of the amylases on
the abdominal drainage fluid in POD3> 207 IU / L and the presence of an abdominal collection
of dimensions equal to or greater than 5 cm in the abdomen CT without contrast performed on
the same day significantly correlates with the risk of developing a biliary fistula.
If confirmed by this study, the practice of maintaining drainage in place up to POD3 could be
validated. Drainages could be removed in POD3 in case of amylase levels in POD1 <666 U / L
and amylase levels in POD3 <252 U / L except in cases where the amylase levels in POD3 are ≥
207 and for which the routine use of abdominal CT on the same day seems to be justified in
order to detect abdominal collections ≥ 5 cm which confirm the risk of this complication. In
this latter category of patients, considering the risk of biliary fistula, drainages could be
maintained beyond POD3.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05435053 -
Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Recruiting |
NCT06065891 -
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
|
N/A | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05048524 -
Peri-operative SLOG for Localized Pancreatic Cancer
|
Phase 2 | |
Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Recruiting |
NCT05679674 -
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
|
N/A | |
Recruiting |
NCT05501379 -
Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
|
||
Recruiting |
NCT04851106 -
Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
|
||
Enrolling by invitation |
NCT04466189 -
Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
|
||
Terminated |
NCT01313416 -
Gemcitabine and CT-011 for Resected Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT01411072 -
Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
|
N/A | |
Active, not recruiting |
NCT01448668 -
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
|
N/A | |
Completed |
NCT01155882 -
Registry Study - Whipple at the Splenic Artery
|
||
Recruiting |
NCT04970056 -
Pancreatic Cancer Early Detection Consortium
|
||
Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03682744 -
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
|
Phase 1 | |
Recruiting |
NCT06036563 -
Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
|