Treatment Strategies for Tumor in Sellar Region With Unruptured Intracranial Aneurysms in the Chinese Population
| Registry | NCT07809178, acronym ChTTSRUIA |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 608 (Estimated) |
| Sponsor | Cheng sen (Other); collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, Xijing Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Chongqing Medical University, Shengjing Hospital, Lanzhou University Second Hospital, The First Hospital of Jilin University, People's Hospital of Xinjiang Uygur Autonomous Region, Guangdong Provincial Hospital of Traditional Chinese Medicine, Huashan Hospital, Jinling Hospital, China |
| Conditions | Unruptured Intracranial Aneurysms, Pituitary Neuroendocrine Tumor, Craniopharyngioma, Meningioma, Germinoma, Rathke Cleft Cysts, Chordoma, Optic Pathway Glioma, Hypothalamic Neoplasms |
| Interventions | Tumor resection followed by aneurysm treatment, Aneurysm treatment followed by tumor resection, Observation (Procedure, other) |
| Dates | start 2026-10-20, primary completion 2028-09-01 (estimated), completion 2031-09-01 (estimated), first posted 2026-09-09, last updated 2026-10-21 |
| Locations | 1 site in China |
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All trials for Unruptured Intracranial Aneurysms All trials for Pituitary Neuroendocrine Tumor All trials of Tumor resection followed by aneurysm treatment All trials of Aneurysm treatment followed by tumor resection
The goal of this observational study is to learn about the treatment strategies for tumor in sellar region with unruptured intracranial aneurysms in the Chinese population. The main question it aims to answer is: For patients with tumor in sellar region combined with unruptured intracranial aneurysms, which condition should be treated first?
The goal of this observational study is to clarify the treatment strategies for tumor in sellar region with unruptured intracranial aneurysms in the Chinese population aged from 18 to 75. The main question it aims to answer is:
* What is the appropriate treatment strategy for patients diagnosed with tumor in sellar region with unruptured intracranial aneurysms?
* Should the tumor be resected first followed by aneurysm treatment, or should the aneurysm be treated prior to tumor resection? Alternatively, is tumor resection alone with regular observation of the aneurysm a viable option?
* What are the patient's intraoperative risks, postoperative complications, and prognosis?
Participants are required to:
* Provide detailed medical records.
* Complete laboratory tests and imaging examinations at scheduled time points and cooperate with neurosurgeons for follow-up visits after the relevant treatments.
This is an observational study. It solely collects patients' pre-operative, intra-operative, and post-operative follow-up information and does not influence the patient's treatment process or clinical decision-making.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Priority to Tumor | Procedure: Tumor resection followed by aneurysm treatment | Tumor resection followed by aneurysm treatment | |
| Priority to Aneurysm | Procedure: Aneurysm treatment followed by tumor resection | Aneurysm treatment followed by tumor resection | |
| Only Tumor | Other: Observation | Tumor resection without aneurysm treatment but observation |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: 1. Preoperative enhanced head MRI showing a suspected diagnosis of a sella region lesion, and preoperative head CTA/DSA confirming an unruptured intracranial aneurysm. 2. Patients with primary sella region tumor and unruptured intracranial aneurysms that have not previously accepted surgical treatment. 3. Patients with tumor in sellar region requiring craniotomy or endoscopic transnasal surgery and/or an aneurysm requiring craniotomy, endovascular treatment, or observation only. 4. The patients are in good general health, without severe underlying medical conditions, and capable of tolerating surgical treatment. 5. Patients or their legal guardians have signed an informed consent form and voluntarily agreed to participate in the clinical trial. Exclusion Criteria: 1. Patients with recurrent sella region tumors. 2. Patients with previously treated intracranial aneurysm. 3. Pregnant or breastfeeding women. 4. Any other condition that, in the investigator's judgment, makes the patient unsuitable for trial participation.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Tiantan Hospital affiliated to Capital Medical University | Beijing, China | China |