Application Research on Endoscopic Pseudocapsule-Based Resection for Pituitary Adenomas

NCT05466357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-06

No results posted yet for this study

Summary

Pituitary adenomas are one of the most common primary central nervous system tumors and have an estimated prevalence of 17%. Management of pituitary adenomas involves a multidisciplinary approach that can incorporate surgical, medical, and/or radiation therapies. Over the last two decades, the endoscopic endonasal approach (EEA) has been extensively developed and refined for the resection of pituitary adenomas (PAs). In recent years, extracapsular resection (ER), which emphasized the importance of the pseudocapsule between the adenoma and surrounding normal gland tissue as a surgical plane, was adopted for more radical resection of the tumor. Therefore, dedicated high-resolution magnetic resonance imaging (MRI) protocols have been proposed to detect pituitary adenoma and accurately guide surgical removal. The evaluation of preoperative imaging for pseudocapsule is very important to the surgical method. Depending on different tumor sizes and pseudocapsule development, investigators adopted different resection strategies. To accomplish complete PA removal and minimize the impact on pituitary functions, intraoperative navigation was used to identify the tumor pseudocapsule, also the suspicious tissue was sent to the pathology department for histopathology intraoperatively. Long-term postoperative follow-up imaging and endocrine data were used to evaluate tumor prognosis. Standardized management and established biobank is critical for pituitary adenomas.

Conditions

  • Pituitary Adenoma

Interventions

PROCEDURE

Excision of pituitary tumor outside pseudocapsule

Dedicated high-resolution magnetic resonance imaging (MRI) protocols have been proposed to detect pituitary adenoma and accurately guide surgical removal. To accomplish complete PA removal and minimize the impact on pituitary functions, intraoperative navigation was used to identify the tumor pseudocapsule. Depending on different tumor sizes and pseudocapsule development, investigators adopted different resection strategies. The suspicious tissue was sent to the pathology department for histopathology intraoperatively. Long-term postoperative follow-up imaging and endocrine data were used to evaluate tumor prognosis before and after operation. Standardized management and established biobank is critical for pituitary adenomas.

Sponsors & Collaborators

  • Subei People's Hospital of Jiangsu Province

    collaborator OTHER
  • The First People's Hospital of Changzhou

    collaborator OTHER
  • Affiliated Hospital of Nantong University

    lead OTHER

Principal Investigators

  • xiao mingbing, MD · Affiliadted hospital of nantong university

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-28
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466357 on ClinicalTrials.gov