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Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas (RAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225494
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Marco Fiore, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
Early recognition of adrenal function deficit in patients undergoing multivisceral surgery including adrenalectomy for primitive retroperitoneal sarcomas

Condition or disease
Adrenal; Functional Disturbance Retroperitoneal Sarcoma Intraoperative Hypotension

Detailed Description:

The extended multivisceral resection of retroperitoneum is the standard treatment for primary retroperitoneal soft tissue sarcomas. This procedure also includes the removal of the healthy adrenal gland ipsilateral to the tumor site.

The investigators think that a such extended surgical approach together with the removal of the adrenal gland may lead to a state of acute adrenal insufficiency and related hemodynamic instability.

In order to recognize this condition the investigators use a low dose ACTH test (Synacthen test) during the 1° and 10° post-operative days.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Serum Cortisol peak after low dose Synachten stimulation test. [ Time Frame: 1st postoperative day ]
    Assessment of early postoperative acute adrenal dysfunction.

  2. Serum Cortisol peak after low dose Synachten stimulation test. [ Time Frame: 10th postoperative day ]
    Assessment of postoperative acute adrenal dysfunction.

  3. Serum Cortisol peak after low dose Synachten stimulation test. [ Time Frame: 4 months after surgery (only if test positive on 10th postoperative day) ]
    Assessment of postoperative chronic adrenal dysfunction.


Secondary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: 30th postoperative day ]
    Correlation between morbidity according to Clavien-Dindo and postoperative adrenal dysfunction

  2. Vasoactive inotropic score [ Time Frame: Intraoperatively and up to 3rd postoperative day ]
    Correlation between intra- and postoperative usage of vasoactive drugs and postoperative adrenal dysfunction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary retroperitoneal sarcoma candidated to extended multivisceral resection
Criteria

Inclusion Criteria:

  • Adult patients (age> 18 years)
  • Diagnosis of retroperitoneal sarcoma
  • Adrenalectomy enbloc included in multivisceral resection
  • Voluntary informed written consent

Exclusion Criteria:

  • Recurrent and / or metastatic disease
  • Patient chronically treated with corticosteroids
  • Primary disorders of adrenal gland
  • Basal serum cortisol values ≤ 7 µg / dL
  • Clinically significant heart disease
  • Altered TSH

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): NCT04225494


Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Lombardia, Italy, 20133
Contact: Marco Fiore, MD    022390 2910    marco.fiore@istitutotumori.mi.it   
Contact: Lorella Rusi, PA    022390 2796    lorella.rusi@istitutotumori.mi.it   
Principal Investigator: Marco Fiore, MD         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications:
Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Álava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krákorová DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schöffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv268-iv269. doi: 10.1093/annonc/mdy321.
Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Álava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krákorová DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schöffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv51-iv67. doi: 10.1093/annonc/mdy096. Erratum in: Ann Oncol. 2018 Oct 1;29(Suppl 4):iv268-iv269.

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Responsible Party: Marco Fiore, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT04225494    
Other Study ID Numbers: 64/19
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual Participant Data will be shared upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Five years after study complexion
Access Criteria: Upon motivated request to PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Fiore, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Retroperitoneal Sarcoma
Surgery
Haemodynamic assessment
Adrenalectomy
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Epinephrine
Racepinephrine
Epinephryl borate
Sarcoma
Hypotension
Vascular Diseases
Cardiovascular Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents