RAF: Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas
Study Details
Study Description
Brief Summary
Early recognition of adrenal function deficit in patients undergoing multivisceral surgery including adrenalectomy for primitive retroperitoneal sarcomas
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Serum Cortisol peak after low dose Synachten stimulation test. [1st postoperative day]
Assessment of early postoperative acute adrenal dysfunction.
- Serum Cortisol peak after low dose Synachten stimulation test. [10th postoperative day]
Assessment of postoperative acute adrenal dysfunction.
- Serum Cortisol peak after low dose Synachten stimulation test. [4 months after surgery (only if test positive on 10th postoperative day)]
Assessment of postoperative chronic adrenal dysfunction.
Secondary Outcome Measures
- Postoperative morbidity [30th postoperative day]
Correlation between morbidity according to Clavien-Dindo and postoperative adrenal dysfunction
- Vasoactive inotropic score [Intraoperatively and up to 3rd postoperative day]
Correlation between intra- and postoperative usage of vasoactive drugs and postoperative adrenal dysfunction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (age> 18 years)
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Diagnosis of retroperitoneal sarcoma
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Adrenalectomy enbloc included in multivisceral resection
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Voluntary informed written consent
Exclusion Criteria:
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Recurrent and / or metastatic disease
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Patient chronically treated with corticosteroids
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Primary disorders of adrenal gland
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Basal serum cortisol values ≤ 7 µg / dL
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Clinically significant heart disease
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Altered TSH
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardia | Italy | 20133 |
Sponsors and Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers SC, Russell JA, Van den Berghe G. Guidelines for the Diagnosis and Management of Critical Illness-Related Corticosteroid Insufficiency (CIRCI) in Critically Ill Patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Crit Care Med. 2017 Dec;45(12):2078-2088. doi: 10.1097/CCM.0000000000002737.
- Burry L, Little A, Hallett D, Mehta S. Detection of critical illness-related corticosteroid insufficiency using 1 μg adrenocorticotropic hormone test. Shock. 2013 Feb;39(2):144-8. doi: 10.1097/SHK.0b013e31827daf0b.
- 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.
- Trans-Atlantic RPS Working Group. Management of primary retroperitoneal sarcoma (RPS) in the adult: a consensus approach from the Trans-Atlantic RPS Working Group. Ann Surg Oncol. 2015 Jan;22(1):256-63. doi: 10.1245/s10434-014-3965-2. Epub 2014 Oct 15.
- Visioni A, Shah R, Gabriel E, Attwood K, Kukar M, Nurkin S. Enhanced Recovery After Surgery for Noncolorectal Surgery?: A Systematic Review and Meta-analysis of Major Abdominal Surgery. Ann Surg. 2018 Jan;267(1):57-65. doi: 10.1097/SLA.0000000000002267. Review.
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