Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	6 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05448690
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Huashan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Surgery, Pituitary Adenoma

Arms & Interventions

Arms

: Non-combined approach (Single or Staged)

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

: Combined approach

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

Interventions

Procedure: - Two different approaches

Please refer to Groups

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