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Pancreas NeoplasmRFATPancreasNCT03570502

Incidence of POPF in the Resection of the Left Pancreas With RFAT

An observational study of Pancreas Neoplasm and Pancreas Cancer, run by Hospital del Mar at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Any age
How many people
38 participants
Where
1 siteSpain
Study dates
Nov 2016to Apr 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with benign and malignant pancreatic tumours.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ignasi Poves, Phd, MD contact

93 248 32 07

ipoves@parcdesalutmar.ca

Spain1 site, 1 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Ignasi Poves, 93 248 32 07, ipoves@parcdesalutmar.cat

    Ignasi Poves, PhD, MD

    Recruiting

Other trials in Spain

About this study

Official title: Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)

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

Read the 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.

Medical subject headings
Pancreatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)

    "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.

    Measured: 1 month

Secondary outcomes (13)

  1. Sex

    Gender or the patient (Male/Female)

    Measured: Inclusion of the patient in the study

  2. Age

    Age of the patient (expressed in years) at the moment of the intervention

    Measured: Inclusion of the patient in the study

  3. Consistency of the pancreas

    It can be defined as "normal", "soft" or "fibrotic"

    Measured: Inclusion of the patient in the study

  4. Level of jaundice

    Bilirubin level at the moment of the intervention and during the first week of postoperative period

    Measured: At the moment of the intervention and during the first week of postoperative period

  5. Type of surgical procedure

    Enucleation, central pancreatectomy or distal pancreatectomy

    Measured: Inclusion of the patient in the study

  6. Laparoscopic or open surgery

    Laparoscopic or open surgery

    Measured: Inclusion of the patient in the study

  7. Total bleeding

    Measured during the procedure

    Measured: During the intervention

  8. Size of the pancreatic duct

    Size of the main pancreatic duct expressed in mm, measured on the last CT before the procedure

    Measured: CT scan prior to surgery

  9. Type of tumour

    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

    Measured: Diagnosis

  10. Postoperative follow-up

    Months of follow-up since the pancreatic procedure

    Measured: 1 year

  11. Type of the postoperative complication

    Description of the type of complication

    Measured: 1 month

  12. Body Mass Index (BMI)

    Measured such as: BMI in kg/m^2

    Measured: Prior the surgery and during the PO follow-up (1 and 6 months)

  13. Diabetes

    Does the patient has diabetes before or after the precedure?

    Measured: Before the precedure and during the PO follow-up (1 and 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2018
  2. Study startNov 2016
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
38 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03570502
Sponsor's protocol ID
2017/7697/I
Acronym
RFATPancreas
Status last verified
Jun 2018
First submitted
17 May 2018
Last updated
27 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26821683

  • 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.

    PubMed 27865280

  • 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.

    PubMed 28857813

  • 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.

    PubMed 15585382

  • 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.

    PubMed 15832417

  • 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.

    PubMed 24977335

  • 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.

    PubMed 23584822

  • 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.

    PubMed 26639388

  • 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.

    PubMed 21529927

  • 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.

    PubMed 16003309

  • 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 CM, 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.

    PubMed 28040257

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreas Neoplasm and Pancreas Cancer, run by Hospital del Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ignasi Poves, Phd, MD (93 248 32 07, ipoves@parcdesalutmar.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03570502, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.

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