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

NCT04225494 | Completed

• 1 other identifier: 64/19
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adrenal; Functional Disturbance; Retroperitoneal Sarcoma; Intraoperative Hypotension

Keywords

Retroperitoneal Sarcoma; Surgery; Haemodynamic assessment; Adrenalectomy

Outcome Measures

Primary Outcomes (3)

• Serum Cortisol peak after low dose Synachten stimulation test.

  Assessment of early postoperative acute adrenal dysfunction.

  1st postoperative day

• Serum Cortisol peak after low dose Synachten stimulation test.

  Assessment of postoperative acute adrenal dysfunction.

  10th postoperative day

• Serum Cortisol peak after low dose Synachten stimulation test.

  Assessment of postoperative chronic adrenal dysfunction.

  4 months after surgery (only if test positive on 10th postoperative day)

Secondary Outcomes (2)

• Postoperative morbidity

  30th postoperative day

• Vasoactive inotropic score

  Intraoperatively and up to 3rd postoperative day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary retroperitoneal sarcoma candidated to extended multivisceral resection

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Related Publications (6)

• 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 Alava 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, Krakorova 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, Schoffski 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. No abstract available.

  PMID: 30285214 BACKGROUND

• 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 Alava 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, Krakorova 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, Schoffski 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. No abstract available.

  PMID: 29846498 BACKGROUND

• 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.

  PMID: 28437313 BACKGROUND

• 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.

  PMID: 25316486 BACKGROUND

• Burry L, Little A, Hallett D, Mehta S. Detection of critical illness-related corticosteroid insufficiency using 1 mug adrenocorticotropic hormone test. Shock. 2013 Feb;39(2):144-8. doi: 10.1097/SHK.0b013e31827daf0b.

  PMID: 23324883 BACKGROUND

• 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.

  PMID: 28938253 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: January 13, 2020
• Study Start: June 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: May 21, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Five years after study complexion
• Access Criteria: Upon motivated request to PI

Locations

IT (1)