Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

NCT00997594 | Completed Phase 2 Results DMC

• 2 other identifiers: 274No secondary IDs
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.

Conditions

Adrenal Tumors

Keywords

adrenal gland

Outcome Measures

Primary Outcomes (3)

• Increase in Catecholamine

  One day

• Serum Cathecholamine Levels

  around one year

• Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation

  Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.

  1 week

Secondary Outcomes (1)

• Increase in Cortisol

  1 day

Study Arms (2)

Adrenal radiofrquency (RF) ablation

ACTIVE COMPARATOR

Patients who wll receive adrenal RF ablation.

Procedure: Radiofrequency ablation

Abdominal RF ablation other than adrenal gland

ACTIVE COMPARATOR

Patients who will receive abdominal radiofrequency ablation other than adrenal gland.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group.

Abdominal RF ablation other than adrenal gland; Adrenal radiofrquency (RF) ablation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable adrenal tumor which will be treated by radiofrequency (RF)ablation
• Blood pressure is 140mmHg or less before RF ablation
• Age of 20-years or more
• Performance status of 0 or 1
• Agreement from the patient

You may not qualify if:

• Platelet count of 50,000/mm\^3 or International normalized ratio (INR)\>1.5

Sponsors & Collaborators

• Mie University: lead

Study Sites (2)

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Mie University

Tsu, Mie-ken, 514-8507, Japan

Location

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Small patient series is one of limitations of this study

Results Point of Contact

• Title: Dr. Koichiro Yamakado
• Organization: Mie University

yama@clin.medic.mie-u.ac.jp

+81-59-231-5029

Study Officials

• Koichiro Yamakado, MD

  Mie University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 19, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 28, 2015
• Results First Posted: February 23, 2011

Record last verified: 2015-04

Locations

JP (2)