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

Completed

• Conditions: Adrenal; Functional Disturbance; Retroperitoneal Sarcoma; Intraoperative Hypotension

• Registration Number: NCT04225494
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Primary Completion: 2020-08-31
• Study Completion: 2021-05-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-02
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Lombardia, Italy