Correlation Between Preoperative Images of PPGL and Intraoperative Hemodynamics

October 30, 2024 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K5426
  • National High Level Hospital C (Other Grant/Funding Number: 2022-PUMCH-B-071)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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