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Incidence of POPF in the Resection of the Left Pancreas With RFAT (RFATPancreas)

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ClinicalTrials.gov Identifier: NCT03570502
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Rita Quesada, Hospital del Mar

Brief Summary:
This study evaluates the impact of the Radiofrequency assisted transection on the rate of postoperative pancreatic fistula (POPF) after performing distal pancreatectomies, central pancreatectomies and pancreatic enucleation

Condition or disease
Pancreas Neoplasm Pancreas Cancer Pancreatic Adenocarcinoma Benign Pancreas Tumor

Detailed Description:

Among the different methods for sealing the remaining pancreas, resection and sealing devices assisted by radiofrequency energy (RF) have been used, both in experimental studies and in clinical trials, in order to try to reduce the POPF rate. One of these devices is the Coolinside®, which is approved for this indication and is currently used in selected cases, at the Hospital del Mar, among other centers.

Although there are several published studies based on similar technology, the existing publications on the use of Coolinside® in the pancreas have been made in rat and pig animal models. In particular, the most recent study published by Dorcaratto et al. compares the Coolinside device vs. the mechanical stapler in porcine model when performing distal pancreatectomies. The results suggest that the Coolinside device was more efficient in the control of the POPF than the stapler with a POPF index of 12% vs. 36%.

Therefore, this study aims to obtain more clinical evidence about the use of Coolinside in pancreatic resections within a clinical context.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)
Study Start Date : November 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas




Primary Outcome Measures :
  1. Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS) [ Time Frame: 1 month ]
    "Grade A postoperative pancreatic fistula" is now redefined and called a "biochemical leak," because it has no clinical importance and is no longer referred to a true pancreatic fistula. Postoperative pancreatic fistula grades B and C are confirmed but defined more strictly. In particular, grade B requires a change in the postoperative management; drains are either left in place >3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.


Secondary Outcome Measures :
  1. Sex [ Time Frame: Inclusion of the patient in the study ]
    Gender or the patient (Male/Female)

  2. Age [ Time Frame: Inclusion of the patient in the study ]
    Age of the patient (expressed in years) at the moment of the intervention

  3. Consistency of the pancreas [ Time Frame: Inclusion of the patient in the study ]
    It can be defined as "normal", "soft" or "fibrotic"

  4. Level of jaundice [ Time Frame: At the moment of the intervention and during the first week of postoperative period ]
    Bilirubin level at the moment of the intervention and during the first week of postoperative period

  5. Type of surgical procedure [ Time Frame: Inclusion of the patient in the study ]
    Enucleation, central pancreatectomy or distal pancreatectomy

  6. Laparoscopic or open surgery [ Time Frame: Inclusion of the patient in the study ]
    Laparoscopic or open surgery

  7. Total bleeding [ Time Frame: During the intervention ]
    Measured during the procedure

  8. Size of the pancreatic duct [ Time Frame: CT scan prior to surgery ]
    Size of the main pancreatic duct expressed in mm, measured on the last CT before the procedure

  9. Type of tumour [ Time Frame: Diagnosis ]
    Serous cystadenoma Acinar cystadenoma Ductal adenocarcinoma Acinar cell carcinoma Cystadenocarcinoma of acinar cells Intraductal papillary mucinous neoplasia associated with invasive carcinoma Mixed carcinoma (ductal-neuroendocrine or acinar-neuroendocrine) Cystic mucinous neoplasia associated with invasive carcinoma Pancreatoblastoma Serous cystadenocarcinoma Pseudopapillary-solid neoplasia

  10. Postoperative follow-up [ Time Frame: 1 year ]
    Months of follow-up since the pancreatic procedure

  11. Type of the postoperative complication [ Time Frame: 1 month ]
    Description of the type of complication

  12. Body Mass Index (BMI) [ Time Frame: Prior the surgery and during the PO follow-up (1 and 6 months) ]
    Measured such as: BMI in kg/m^2

  13. Diabetes [ Time Frame: Before the precedure and during the PO follow-up (1 and 6 months) ]
    Does the patient has diabetes before or after the precedure?



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with benign and malignant pancreatic tumours.
Criteria

Inclusion Criteria:

  • Patients with benign or malignant lesions of the pancreas
  • Subjected to distal, central pancreatectomy or enucleations of the left pancreas
  • Patients ASA (American Society of Anesthesiologists I-III
  • Open or laparoscopic approach.

Exclusion Criteria:

  • ASA ≥IV patients
  • Patients with limitrophic or neuroendocrine lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570502


Contacts
Contact: Ignasi Poves, Phd, MD 93 248 32 07 ipoves@parcdesalutmar.ca

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Ignasi Poves    93 248 32 07    ipoves@parcdesalutmar.cat   
Principal Investigator: Ignasi Poves, PhD, MD         
Sub-Investigator: Fernando Burdío, PhD, MD         
Sub-Investigator: Dimitri Dorcaratto, PhD, MD         
Sponsors and Collaborators
Hospital del Mar

Publications:

Responsible Party: Rita Quesada, Clinical Trial Monitor, Hospital del Mar
ClinicalTrials.gov Identifier: NCT03570502     History of Changes
Other Study ID Numbers: 2017/7697/I
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Adenocarcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents