- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570502
Incidence of POPF in the Resection of the Left Pancreas With RFAT (RFATPancreas)
Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ignasi Poves, Phd, MD
- Phone Number: 93 248 32 07
- Email: ipoves@parcdesalutmar.ca
Study Locations
-
-
-
Barcelona, Spain, 08003
- Recruiting
- Hospital Del Mar
-
Contact:
- Ignasi Poves
- Phone Number: 93 248 32 07
- Email: ipoves@parcdesalutmar.cat
-
Principal Investigator:
- Ignasi Poves, PhD, MD
-
Sub-Investigator:
- Fernando Burdío, PhD, MD
-
Sub-Investigator:
- Dimitri Dorcaratto, PhD, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sex
Time Frame: Inclusion of the patient in the study
|
Gender or the patient (Male/Female)
|
Inclusion of the patient in the study
|
Age
Time Frame: Inclusion of the patient in the study
|
Age of the patient (expressed in years) at the moment of the intervention
|
Inclusion of the patient in the study
|
Consistency of the pancreas
Time Frame: Inclusion of the patient in the study
|
It can be defined as "normal", "soft" or "fibrotic"
|
Inclusion of the patient in the study
|
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
|
At the moment of the intervention and during the first week of postoperative period
|
Type of surgical procedure
Time Frame: Inclusion of the patient in the study
|
Enucleation, central pancreatectomy or distal pancreatectomy
|
Inclusion of the patient in the study
|
Laparoscopic or open surgery
Time Frame: Inclusion of the patient in the study
|
Laparoscopic or open surgery
|
Inclusion of the patient in the study
|
Total bleeding
Time Frame: During the intervention
|
Measured during the procedure
|
During the intervention
|
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
|
CT scan prior to surgery
|
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
|
Diagnosis
|
Postoperative follow-up
Time Frame: 1 year
|
Months of follow-up since the pancreatic procedure
|
1 year
|
Type of the postoperative complication
Time Frame: 1 month
|
Description of the type of complication
|
1 month
|
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
|
Prior the surgery and during the PO follow-up (1 and 6 months)
|
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?
|
Before the precedure and during the PO follow-up (1 and 6 months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
- Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.
- Lin JW, Cameron JL, Yeo CJ, Riall TS, Lillemoe KD. Risk factors and outcomes in postpancreaticoduodenectomy pancreaticocutaneous fistula. J Gastrointest Surg. 2004 Dec;8(8):951-9. doi: 10.1016/j.gassur.2004.09.044.
- Ecker BL, McMillan MT, Allegrini V, Bassi C, Beane JD, Beckman RM, Behrman SW, Dickson EJ, Callery MP, Christein JD, Drebin JA, Hollis RH, House MG, Jamieson NB, Javed AA, Kent TS, Kluger MD, Kowalsky SJ, Maggino L, Malleo G, Valero V 3rd, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019 Jan;269(1):143-149. doi: 10.1097/SLA.0000000000002491.
- Burdio F, Dorcaratto D, Hernandez L, Andaluz A, Moll X, Quesada R, Poves I, Grande L, Caceres M, Berjano E. Radiofrequency-induced heating versus mechanical stapler for pancreatic stump closure: in vivo comparative study. Int J Hyperthermia. 2016 May;32(3):272-80. doi: 10.3109/02656736.2015.1136845. Epub 2016 Jan 29.
- Malleo G, Vollmer CM Jr. Postpancreatectomy Complications and Management. Surg Clin North Am. 2016 Dec;96(6):1313-1336. doi: 10.1016/j.suc.2016.07.013.
- Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456.
- Quesada R, Burdio F, Iglesias M, Dorcaratto D, Caceres M, Andaluz A, Poves I, Castiella T, Sanchez P, Berjano E, Grande L. Radiofrequency pancreatic ablation and section of the main pancreatic duct does not lead to necrotizing pancreatitis. Pancreas. 2014 Aug;43(6):931-7. doi: 10.1097/MPA.0000000000000156.
- Dorcaratto D, Burdio F, Fondevila D, Andaluz A, Quesada R, Poves I, Caceres M, Mayol X, Berjano E, Grande L. Radiofrequency is a secure and effective method for pancreatic transection in laparoscopic distal pancreatectomy: results of a randomized, controlled trial in an experimental model. Surg Endosc. 2013 Oct;27(10):3710-9. doi: 10.1007/s00464-013-2952-1. Epub 2013 Apr 13.
- Quesada R, Andaluz A, Caceres M, Moll X, Iglesias M, Dorcaratto D, Poves I, Berjano E, Grande L, Burdio F. Long-term evolution of acinar-to-ductal metaplasia and beta-cell mass after radiofrequency-assisted transection of the pancreas in a controlled large animal model. Pancreatology. 2016 Jan-Feb;16(1):38-43. doi: 10.1016/j.pan.2015.10.014. Epub 2015 Nov 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/7697/I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Adenocarcinoma
-
Fudan UniversityUnknownStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
Roswell Park Cancer InstituteNot yet recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal Adenocarcinoma | Advanced Pancreatic Ductal Adenocarcinoma | Unresectable Pancreatic Ductal Adenocarcinoma and other conditionsUnited States
-
Xian-Jun YuCompletedStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
Xian-Jun YuCompletedStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
Scandion Oncology A/SAlcedis GmbHRecruitingMetastatic Pancreatic Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Inoperable Disease | Localized Pancreatic AdenocarcinomaDenmark, Germany
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingPancreas Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic AdenocarcinomaUnited States
-
Lawson Health Research InstituteLondon Health Sciences FoundationNot yet recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Adenocarcinoma
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
HonorHealth Research InstituteActive, not recruitingLocally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic Adenocarcinoma | Untreated Resectable Pancreatic AdenocarcinomaUnited States