Clinical trial NCT04225494: Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas
Official title: Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal; Functional Disturbance
Retroperitoneal Sarcoma
Intraoperative Hypotension
Keywords: Retroperitoneal Sarcoma
Surgery
Haemodynamic assessment
Adrenalectomy
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary retroperitoneal sarcoma candidated to extended multivisceral resection

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

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.

Eligibility 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

Primary outcomes:
measure: Serum Cortisol peak after low dose Synachten stimulation test.
timeFrame: 1st postoperative day
measure: Serum Cortisol peak after low dose Synachten stimulation test.
timeFrame: 10th postoperative day
measure: Serum Cortisol peak after low dose Synachten stimulation test.
timeFrame: 4 months after surgery (only if test positive on 10th postoperative day)
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: 30th postoperative day
measure: Vasoactive inotropic score
timeFrame: Intraoperatively and up to 3rd postoperative day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
Study officials:
References:
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