China Treatment Trial for Tumor in Sellar Region With Unruptured Intracranial Aneurysm

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorCheng sen

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preoperative enhanced head MRI showing a suspected diagnosis of a sella region lesion, and preoperative head CTA/DSA confirming an unruptured intracranial aneurysm.

Patients with primary sella region tumor and unruptured intracranial aneurysms that have not previously accepted surgical treatment.

Patients with tumor in sellar region requiring craniotomy or endoscopic transnasal surgery and/or an aneurysm requiring craniotomy, endovascular treatment, or observation only.

The patients are in good general health, without severe underlying medical conditions, and capable of tolerating surgical treatment.

Disqualifiers

Patients with recurrent sella region tumors.

Patients with previously treated intracranial aneurysm.

Pregnant or breastfeeding women.

Any other condition that, in the investigator's judgment, makes the patient unsuitable for trial participation.

Trial population

Patients diagnosed of tumor in sellar region with unruptured intracranial aneurysms in the Chinese population

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Tumor resection followed by aneurysm treatment

    Procedure/Surgery

    Tumor resection followed by aneurysm treatment

  • Aneurysm treatment followed by tumor resection

    Procedure/Surgery

    Aneurysm treatment followed by tumor resection

  • Observation

    Other intervention

    Tumor resection without aneurysm treatment but observation

Treatment groups

608 Participants
are divided into 3 treatment groups
Group A: Priority to Tumor1 intervention
Group B: Priority to Aneurysm1 intervention
Group C: Only Tumor1 intervention

Trial outcomes

Primary outcomes

1

Aneurysm progression

The diameter of aneurysm neck, the diameter of aneurysm dome, the volume of aneurysm, aneurysm rupture status

Time frame
From enrollment to the end of treatment at 24 months
2

Tumor related complication and progression

The related complication and progression of tumor in sellar region: pituitary hormone level, visual acuity and visual field, hydrocephalus and tumor recurrence.

Time frame
From enrollment to the end of treatment at 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cheng sen

Lead sponsor

Capital Medical University

Sponsor institution

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

West China Hospital

Collaborator

Xijing Hospital

Collaborator

Shandong Provincial Hospital

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Shengjing Hospital

Collaborator

Lanzhou University Second Hospital

Collaborator

The First Hospital of Jilin University

Collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

Huashan Hospital

Collaborator

Jinling Hospital, China

Collaborator

This trial is not recruiting at the moment. You can still explore other options: