Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement

Pituitary Adenoma Clinical Trial

Official title:

Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04863456
• Other study ID #: [2021]IEC-J(227)
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2021
• Source: Wuhan Union Hospital, China
• Contact: Tao Huang, PhD, MD
• Phone: 027-85350819
• Email: neuroht[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)

Description:

There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement

• Informed consent

Exclusion Criteria:

• No follow-up possible

• Emergency surgery without informed consent

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• Total resection
Total resection of HIPA in a single surgery
• Staged resection
HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date
• Subtotal resection followed by stereotactic radiation therapy
HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of QoL (Quality of Life, EQ-5D) for the first surgery	EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years	baseline (before the first surgery), 2 years after the first surgery
Primary	Change of QoL (Quality of Life, EQ-5D) for the second intervention	EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months	baseline (before the second intervention), 3 months after the second intervention
Secondary	Change of Visual Acuity statue	Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years	baseline (before the first surgery), 2 years after the first surgery
Secondary	Change of Visual Field statue	Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years	baseline (before the first surgery), 2 years after the first surgery
Secondary	Change of Hormone Replacement Therapy	Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years	baseline (before the first surgery), 2 years after the first surgery
Secondary	Extent of resection	Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences.	baseline (before the first surgery), 2 years after the first surgery