Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas (RAF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04225494|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease|
|Adrenal; Functional Disturbance Retroperitoneal Sarcoma Intraoperative Hypotension|
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]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||4 Months|
|Official Title:||Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||July 1, 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225494
|Fondazione IRCCS Istituto Nazionale dei Tumori||Recruiting|
|Milan, Lombardia, Italy, 20133|
|Contact: Marco Fiore, MD 022390 2910 firstname.lastname@example.org|
|Contact: Lorella Rusi, PA 022390 2796 email@example.com|
|Principal Investigator: Marco Fiore, MD|