PFDD Versus PFDRT in Chiari Decompression Surgery

Tonsillectomy Clinical Trial

Official title:

Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079125
• Other study ID #: DDCS
• Status: Recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: Xuanwu Hospital, Beijing
• Contact: fengzeng jian, M.D.
• Phone: +861083198899
• Email: jianfengzeng[@]xwh.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

Description:

Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the decompression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age =14 years old
• Chiari malformation type I =5 mm tonsillar ectopia
• a syrinx with a width > 50% of the cross-sectional diameter of the spinal cord , and a length of at least 2 cervical and/or thoracic vertebral segments.
• MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center

Exclusion Criteria:

• included one or more of the following preexisting conditions: hydrocephalus; tumor; brain trauma; stroke; meningitis; abscess;
• other congenital anomalies of the brain or skull base; vertebral anomalies (i.e., Klippel-Feil, atlas assimilation, etc.);
• degenerative or demyelinating disease;
• CM-I without syringomyelia;
• syringomyelia with cerebellar tonsils in a normal position;
• fibromyalgia;
• chronic fatigue syndrome;
• prior posterior fossa surgery.
• Unable to share pre-decompression MRI of the brain and spine Patients who do not wish to participate

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation Type I
• Congenital Abnormalities
• Tonsillectomy

Intervention

Procedure:
• Posterior fossa decompression with duraplasty
The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft.
• PFDD with tonsillar resection/reduction
The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. Then herniated tonsil will be manipulated and adhesion was released. After microsurgical manipulated, the dura is sewn closed with a dural graft.

Locations

Country	Name	City	State
China	Fengzeng Jian	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (6)

Chenghua Y, Min W, Wei L, Xinyu W, Fengzeng J. Comparison of foramen magnum decompression with and without duraplasty in the treatment of adult Chiari malformation Type I: a meta-analysis and systematic review. Turk Neurosurg. 2022 Jan 10. doi: 10.5137/1019-5149.JTN.35727-21.5. Online ahead of print. — View Citation

Guan J, Yuan C, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Intradural Pathology Causing Cerebrospinal Fluid Obstruction in Syringomyelia and Effectiveness of Foramen Magnum and Foramen of Magendie Dredging Treatment. World Neurosurg. 2020 Dec;144:e178-e188. doi: 10.1016/j.wneu.2020.08.068. Epub 2020 Aug 15. — View Citation

Hale AT, Adelson PD, Albert GW, Aldana PR, Alden TD, Anderson RCE, Bauer DF, Bonfield CM, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Durham SR, Ellenbogen RG, Eskandari R, George TM, Grant GA, Graupman PC, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Heuer GG, Iantosca M, Iskandar BJ, Jackson EM, Johnston JM, Keating RF, Leonard JR, Maher CO, Mangano FT, McComb JG, Meehan T, Menezes AH, O'Neill B, Olavarria G, Park TS, Ragheb J, Selden NR, Shah MN, Smyth MD, Stone SSD, Strahle JM, Wait SD, Wellons JC, Whitehead WE, Shannon CN, Limbrick DD; Park-Reeves Syringomyelia Research Consortium Investigators. Factors associated with syrinx size in pediatric patients treated for Chiari malformation type I and syringomyelia: a study from the Park-Reeves Syringomyelia Research Consortium. J Neurosurg Pediatr. 2020 Mar 6:1-11. doi: 10.3171/2020.1.PEDS19493. Online ahead of print. — View Citation

Heiss JD, Jarvis K, Smith RK, Eskioglu E, Gierthmuehlen M, Patronas NJ, Butman JA, Argersinger DP, Lonser RR, Oldfield EH. Origin of Syrinx Fluid in Syringomyelia: A Physiological Study. Neurosurgery. 2019 Feb 1;84(2):457-468. doi: 10.1093/neuros/nyy072. — View Citation

Koueik J, Sandoval-Garcia C, Kestle JRW, Rocque BG, Frim DM, Grant GA, Keating RF, Muh CR, Oakes WJ, Pollack IF, Selden NR, Tubbs RS, Tuite GF, Warf B, Rajamanickam V, Broman AT, Haughton V, Rebsamen S, George TM, Iskandar BJ. Outcomes in children undergoing posterior fossa decompression and duraplasty with and without tonsillar reduction for Chiari malformation type I and syringomyelia: a pilot prospective multicenter cohort study. J Neurosurg Pediatr. 2019 Oct 18:1-9. doi: 10.3171/2019.8.PEDS19154. Online ahead of print. — View Citation

Yuan C, Guan J, Du Y, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Repeat Craniocervical Decompression in Patients with a Persistent or Worsening Syrinx: A Preliminary Report and Early Results. World Neurosurg. 2020 Jun;138:e95-e105. doi: 10.1016/j.wneu.2020.02.015. Epub 2020 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement or resolution of the syrinx,	defined as > 50% improvement in length, maximal cross-sectional diameter, or both.	3-6, 12 and 24 months
Secondary	complication rates	Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications	12 months
Secondary	Chicago Chiari Outcome Scale (CCOS) scale		12 months
Secondary	visual analog scale (VAS)	degree of the pain	12 months
Secondary	Japanese Orthopaedic Association (JOA) scale	Japanese Orthopaedic Association Scores	12 months
Secondary	blood loss	blood loss	12 months
Secondary	hospital stay	hospital stay	12 months
Secondary	cost for the hospitalisation.	cost for the hospitalisation.	12 months