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

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04863456
• Collaborator: (none)
• Enrollment: 90
• Arms: 2
• Anticipated Duration (Months): 44

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pituitary Adenoma	Procedure: Total resection; Procedure: Staged resection; Procedure: Subtotal resection followed by stereotactic radiation therapy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
• Anticipated Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIPA group of Puget grade 1 the tumor abuting or displacing the hypothalamus in the preoperative MR images	Procedure: Total resection; Total resection of HIPA in a single surgery; Procedure: Staged resection; HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date; Procedure: 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
Experimental: HIPA group of Puget grade 2 hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images	Procedure: Total resection; Total resection of HIPA in a single surgery; Procedure: Staged resection; HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date; Procedure: 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

Outcome Measures

Primary Outcome Measures

1. Change of QoL (Quality of Life, EQ-5D) for the first surgery [baseline (before the first surgery), 2 years after the first surgery]

   EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years

2. Change of QoL (Quality of Life, EQ-5D) for the second intervention [baseline (before the second intervention), 3 months after the second intervention]

   EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months

Secondary Outcome Measures

1. Change of Visual Acuity statue [baseline (before the first surgery), 2 years after the first surgery]

   Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years

2. Change of Visual Field statue [baseline (before the first surgery), 2 years after the first surgery]

   Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years

3. Change of Hormone Replacement Therapy [baseline (before the first surgery), 2 years after the first surgery]

   Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years

4. Extent of resection [baseline (before the first surgery), 2 years after the first surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

• Study Director: Tao Huang, PhD, MD, Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT04863456
• Other Study ID Numbers: [2021]IEC-J(227)
• First Posted: Apr 28, 2021
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wuhan Union Hospital, China: pituitary adenoma; treatment strategy; Hypothalamus
• Additional relevant MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases

Study Results

No Results Posted as of Apr 28, 2021