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

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ClinicalTrials.gov Identifier: NCT04225494
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Marco Fiore, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date October 1, 2019
First Posted Date January 13, 2020
Last Update Posted Date January 13, 2020
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2020)
  • Serum Cortisol peak after low dose Synachten stimulation test. [ Time Frame: 1st postoperative day ]
    Assessment of early postoperative acute adrenal dysfunction.
  • Serum Cortisol peak after low dose Synachten stimulation test. [ Time Frame: 10th postoperative day ]
    Assessment of postoperative acute adrenal dysfunction.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 9, 2020)
  • Postoperative morbidity [ Time Frame: 30th postoperative day ]
    Correlation between morbidity according to Clavien-Dindo and postoperative adrenal dysfunction
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary retroperitoneal sarcoma candidated to extended multivisceral resection
Condition
  • Adrenal; Functional Disturbance
  • Retroperitoneal Sarcoma
  • Intraoperative Hypotension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 9, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04225494
Other Study ID Numbers 64/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual Participant Data will be shared upon request.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Five years after study complexion
Access Criteria: Upon motivated request to PI
Responsible Party Marco Fiore, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date January 2020