Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Fudan University

Status: Completed

Conditions: Surgery; Pituitary Adenoma

Treatments: Procedure: Non-combined approach; Procedure: Two different approaches

Study type: Interventional

Funder types: Other

Identifiers

NCT05448690

KY2022-060

Details and patient eligibility

About

The surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options.

A single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor.

The advantage of the combined approach is that the tumor can be removed to the greatest extent possible. In addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. In this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced.

In some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. However, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors.

Given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.

Enrollment: 600 patients

Sex: All

Ages: 6 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Giant pituitary adenoma (> 4cm in diameter)

Exclusion criteria

• most of the tumor were in the sellae, sphenoidal sinus or clivus.
• patients with craniopharyngioma or meningioma.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Non-combined approach (Single or Staged)

Active Comparator group

Description:

Patients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery

Treatment:

Procedure: Non-combined approach

Combined approach

Experimental group

Description:

Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously

Treatment:

Procedure: Two different approaches