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NCT Number: NCT06669481

Correlation Between Preoperative Images of PPGL and Intraoperative Hemodynamics

This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.

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Key information

Conditions

Pheochromocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

About this study

This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery

Exclusion criteria

  • 1) surgery was performed more than 6 months after 131I-MIBG scintigraphy; 2) tumor located in bladder where radioactive urine would influence assessment of tumor; 3) tumor was not resected as a whole; 4) resected tumor was not PPGLs confirmed by pathology; 5) 131I-MIBG scintigraphy images or intraoperative BP was not available for assessment.

Treatment and study plan

Semiquantitative 131I-MIBG Scintigraphy Assessment

Other

Patients received thyroid blockade using solution of potassium iodide before the examination. After intravenous administration of 111 MBq of 131I-MIBG, whole body planar images were acquired at 24 hours (Day 1) and 48 hours (Day 2), respectively.

Primary outcomes

  1. Difference of SBP ARV and MAP ARV in Different Groups

    Time frame: Intraoperative systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded automatically in a 5 min interval from the beginning to the end of surgery.

    Mean arterial pressure (MAP) was calculated with the formula: MAP=1/3*SBP+2/3*DBP. ARV, which was defined as the average of absolute difference between successive BP values

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Semiquantitative 131I-MIBG Scintigraphy Predicts Intraoperative Blood Pressure Fluctuation in Patients Undergoing Surgery for Pheochromocytoma and Paraganglioma

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

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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