Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms

Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness. However, there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping, especially the latter via keyhole approaches, which has been widely used in recent years. Based on the data of a single center, a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment, including endovascular coiling, microsurgical clipping via conventional craniotomy and keyhole approaches, in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm; Randomized Controlled Trial; Endovascular Procedures; Microsurgery
• Intervention / Treatment: Procedure: keyhole microneurosurgery; Procedure: conventional microneurosurgery; Procedure: endovascular coiling

Detailed Description

Consecutive patients of a single center will be screened. If spontaneous subarachnoid hemorrhage (SAH) is confirmed by head computed tomography (CT), a diagnostic CT angiography (CTA) or digital subtraction angiography (DSA) will be carried out emergently. A patients harbored a single intracranial aneurysm of anterior circulation that resulted in SAH will be concerned. Based on the assessment of condition, the patient will enrolled into this study without indication of decompressive craniectomy. The enrolled patients will be divided randomly into 3 groups, who experienced endovascular coiling, microsurgical clipping via conventional craniotomy and via keyhole approaches. All of these treatment will be conducted by a same senior neurosurgeon. CTA or DSA were followed up regularly. The occlusion rate, operative period, hospitalization duration and cost, surgical complications were compared and analyzed.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Single intracranial anterior circulation aneurysm diagnosed by CTA or DSA
• CT showed that subarachnoid hemorrhage originated from the rupture of the aneurysm and was confirmed during operation
• No indication of decompressive craniectomy (Hunt-Hess grade ≤ 4, Glasgow Coma Scale ≥ 7, no brain herniation; CT showed midline displacement < 5mm)
• The aneurysm is suitable for both endovascular treatment and microsurgical clipping

Exclusion Criteria:

• The patients and their families did not agree to join the study
• Patients with unruptured anterior circulation aneurysms
• Patients with posterior circulation aneurysms
• Patients with multiple intracranial aneurysms
• Those who cannot receive treatment due to serious concomitant diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: keyhole group; patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.	Procedure: keyhole microneurosurgery; microsurgical clipping via keyhole approach
Experimental: conventional group; patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.	Procedure: conventional microneurosurgery; microsurgical clipping via conventional craniotomy
Experimental: endovascular group; patient harbored aneurysm who was treated by endovascular coiling via femoral approach.	Procedure: endovascular coiling; endovascular coiling via femoral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occlusion rate of aneurysm	occlusion rate of aneurysm	an average of 1 month
operative time	total operative duration	an average of 1 month
hospitalization time	hospitalization duration	up to 3 months after discharge
hospitalization cost	cost during hospitalization	up to 3 months after discharge
postoperative complication rate	complication rate after intervention	up to 3 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrent rate of aneurysm	recurrent rate after treatment of aneurysm	6 months after treatment
long-term complication rate	complication rate during follow-up	6 months after treatment

Collaborators and Investigators

• Sponsor: ZhuQing
• Investigators: Study Director: Qing Lan, Doctor, Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: SJWKvascular001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No