Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor

NCT05173467 | Unknown

• 1 other identifier: 2021SL046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

With significant advances in diagnostic imaging and systemic therapies for oncologic disease, spinal metastasis with neurological dysfunction and mechanical instability has become an indication for surgery. Even if traditional-open surgery was palliative, the treatment of spinal metastasis also carried significant surgical morbidity. Those high morbidity and complication rates may influence the quality of patients with a limited life expectancy. Invasion-controlled surgery was utilized with Robot-assisted surgery approach against symptomatic spinal metastasis. Increasing interest in the potential for improved consistency, complication reduction, and decreased length of hospitalization through robot utilization is evident from the rapid growth of publications seen in recent years. So, the investigators wish to evaluate the advantages of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery spinal surgery in patients with metastatic spinal cord compression.

Conditions

Minimally Invasive Surgery; Spinal Metastases

Keywords

Minimal surgery; Spinal Metastases; invsasion-controlled surgery; traditional-open surgery; Robot-assisted

Outcome Measures

Primary Outcomes (1)

• operative bleeding

  It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.

  Intraoperative

Secondary Outcomes (12)

• operation time

  Intraoperative

• Intraoperative transfusion volume

  Intraoperative

• Intraoperative fluoroscopy dose

  Intraoperative

• VAS Scores

  less than 2 years

• Frankel Scores

  less than 2 years

Study Arms (2)

Robot-assisted Invasion-controlled Surgery

EXPERIMENTAL

Procedure: Robot-assisted Invasion-controlled Surgery

Traditional-open Surgery

PLACEBO COMPARATOR

Procedure: Traditional-open Surgery

Interventions

Robot-assisted Invasion-controlled Surgery PROCEDURE

The concept of invasion-controlled surgery (ICS) for spinal metastasis has been put forward against the spinal instability and neurological dysfunction of frail patients that might not allowed for radical traditional open surgery including improvements of multidisciplinary dynamic assessments, endovascular detachable balloon embolization, minimal-invasion by using expandable working tubes, percutaneous pedicle screws, and some accurate therapy. ICS could provide immediate stability, deformity correction, and recovery of neurological function.

Robot-assisted Invasion-controlled Surgery

Traditional-open Surgery PROCEDURE

This traditionally requires a midline incision, bilateral muscle strip, and multilevel laminectomy to provide adequate access and safe removal of the tumor.

Traditional-open Surgery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of spinal metastasis (previously confirmed diagnosis of lung cancer, liver cancer, prostate cancer, breast cancer, kidney cancer, digestive tract cancer, imaging indicated the presence of metastatic lesions in the spine)
• Patients with symptoms of spinal instability or nerve compression (SINS score of spinal instability ≥7, spinal nerve compression according to spinal cord injury Classification, grade A-D)
• Metastases are located in the thoracic and/or lumbar vertebrae
• The patient's expected survival was longer than 6 months
• The subjects or their legal representatives were able to understand the study purpose, demonstrate adequate compliance with the study protocol, and sign informed consent

You may not qualify if:

• He had previously operated on the same site
• Spontaneous multiple compression fractures of the spine;
• There is malformed osteitis (Paget's bone disease), osteomalacia, or other metabolic bone disease;
• here were developmental vertebral malformations or vertebral body and pedicle dysplasia in the spinal segment to be treated by surgery
• Presence of heart, lung, liver or kidney failure or other serious diseases (such as osteomyelitis, systemic infection, severe hemorrhagic disease, active disseminated intravascular coagulation, serious cardiovascular disease or myocardial infarction within 6 months prior to enrollment, cerebral infarction within 6 months prior to enrollment, severe psychiatric history)
• Pregnant or lactating women
• Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment

Sponsors & Collaborators

• Wei Xu: lead

Study Sites (1)

ChangZheng Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

Study Officials

• Jianru Xiao, Profession

  Shanghai Changzheng Hospital

  STUDY CHAIR

• Wei Xu, Profession

  Shanghai Changzheng Hospital

  STUDY DIRECTOR

• Bo Li, Profession

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

• Pengru Wang, Profession

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei Xu, profession

CONTACT

13761278657; xuweichangzheng@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: December 25, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2023
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

CN (1)