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Completed

NCT Number: NCT04225494

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

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

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Key information

Conditions

Adrenal; Functional Disturbance Intraoperative Hypotension Retroperitoneal Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study

Acronym: RAF

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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