Mandibular Reconstruction Preplanning (ViPMR)

Oral Cancer Clinical Trial

— ViPMR  

Official title:

Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429099
• Other study ID #: H20-03314
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 15, 2022
• Est. completion date: October 15, 2026

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: Eitan Prisman, MD, FRCSC
• Phone: 6048754126
• Email: eitan.prisman[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: October 15, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery

• are over the age of 18

• cognitive ability and language skills that allow participation in the trial

• provide informed consent

Exclusion Criteria:

• severe comorbidities including metastatic disease

• do not have a recent (within 30 days) CT scan and are unable/unwilling to receive a head CT scan at the latest 6 days prior to surgery

• prior history of head or neck cancer within last 5 years

• prior history of head or neck radiation treatment at any time

• pregnant of lactating women

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer
• Oral Cavity Cancer

Intervention

Procedure:
• Virtual Surgical Planning (VSP)
The 3D reconstruction model, not requiring sterilization, will be sent directly to the SS. Prior to surgery, the SS will prebend a titanium fixation plate to the reconstruction model. Both the surgical cutting guides and titanium plate will be sterilized prior to use in surgery. If the planned resection cannot proceed (possibly due to tumour growth), the surgical team will note the reason for abandonment and conduct a standard FHS. Intraoperatively, the SS will apply the mandibular cutting guide to make the resection, remove the resected component and apply the pre-bent plate. Next, either the fibular or scapular cutting guide is applied to harvest the transplant which is then secured to the plate. The flap is re-vascularized by joining it to blood vessels in the neck.
• Free-Hand Surgery
The SS will adopt their standard procedure for the mandibular resection and reconstruction. This typically involves bending a titanium fixation plate, harvesting of the bony flap, and shaping of the segments all intraoperatively based on the SS's judgement.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bony Union	The primary outcome is nonunion as assessed by two independent radiologists at Vancouver General Hospital, blinded to the intervention, based on the 12-month postoperative CT scan. Each apposition (between native bone-flap or between flap segments) will be assessed as nonunion, partial union, and complete union. Cases where there is disagreement between reviewers will undergo consensus review, any persisting disagreements will be reviewed by a third radiologist and classification will be based on the majority vote.	Assessed on CT scans 12 months postoperatively
Secondary	Difference in Intracondylar Distance	Comparison to assess structural reconstruction accuracy of postoperative versus preoperative cephalometrics. This will be calculated as the absolute value of postoperative intracondylar distance minus preoperative intercondylar distance (millimeters).	Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans
Secondary	Difference in Mandibular Angles	Comparison to assess structural reconstruction accuracy of postoperative versus preoperative cephalometrics. This will calculated as the absolute value of postoperative mandibular angle minus preoperative mandibular angle (degrees).	Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans
Secondary	University of Washington Quality of Life (UWQoL)	A questionnaire that measures quality of life which records responses on the 5-point Likert scale; minimum of 1 (strongly disagree) and maximum of 5 (strongly agree).	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	EQ-5D-5L Survey	Another questionnaire which measures quality of life. Responses recorded as checkboxes that are ticked if applicable to the participant. Participant health is measured on a scale of 0 (worst health imaginable) to 100 (best health imaginable).	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Dysphagia	Measured through responses to the M.D. Anderson Dysphagia Inventory (MDADI) for assessment of dysphagia. MDADI records responses on the 5-point Likert scale; minimum of 1 (strongly disagree) and maximum of 5 (strongly agree).	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Oral Health	Measured through responses to the General Oral Health Assessment Index (GOHAI). Responses recorded one of 5 choices with a point value assigned to each (1 = always, 2 = often, 3 = sometimes, 4 = seldom, and 5 = never).	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Fibula harvest site complications	Measured through responses to the Lower-Limb Tasks Questionnaire (LLTQ) if patient had fibula harvested for reconstruction. or the Disabilities of the Arm, Shoulder, Hand (DASH) questionnaire if patients had scapula harvested for reconstruction. Intends to measure donor site morbidity by assessing ease of task completion (4 = no difficulty, 3 = mild difficulty, 2 = moderate difficulty, 1 = severe difficulty, 0 = unable), as well as importance of task (4 = very important, 3 = moderately important, 2 = mildly important, 1 = not important).	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Scapula harvest site complications	Measured through responses to the Disabilities of the Arm, Shoulder, Hand (DASH) questionnaire if patients had scapula harvested for reconstruction. Intends to measure donor site morbidity by assessing difficulty during tasks (1 = no difficulty, 2 = mild difficulty, 3 = moderate difficulty, 4 = severe difficulty, 5 = unable).	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Economic analysis	Measured through responses to Health Utilization Questionnaire (HUQ) survey to measure impact to patients economic state as a result of their surgery. Records whether participant has experienced certain situations as no or yes (and asks frequency of these situations). Also asks for associated costs that may	Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Occlusal force (bite force)	Measured through Dental PreScale System (DPS-Fujifilm Global) as an assessment of patient bite force.	Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)
Secondary	Dental Implantability	Oral surgeon on the trial will assess the feasibility of the creation of dental implants for the patient postoperatively; responses will recorded as either feasible (1) or infeasible (0).	Up to 100 days after the post-operative CT scan.
Secondary	Operative Time	Time from first incision to the end of surgical closure as documented on the nursing record.	Initial Surgery
Secondary	Ischaemic Time	Time from cutting off blood supply to operative region to restoring blood supply and flow as documented on the nursing record.	Initial Surgery
Secondary	Length of Stay	Time from admission into hospital preoperatively to discharge from hospital postoperatively as documented on patient's medical chart or date of death, whichever came first.	From date of patient's preoperative hospital admission until the date of hospital discharge postoperatively or date of death from any cause, whichever came first, assessed up to 100 days
Secondary	Rate of Plate Extrusion	Complication with plate where may partially or fully be exposed to external environment.	Patients will be monitored for 1 year post-operatively
Secondary	Rate of Flap Failure	Complication with flap where donor bone no longer viable as reconstruction piece and replacement required. May be due to ischemic necrosis, infection, osteoradionecrosis, fracturing, etc.	Patients will be monitored for 1 year post-operatively
Secondary	Rate of Cancer Reoccurrence	Complication where cancer that was confirmed to be removed (negative resection margins, subsequent chemoradiotherapy results, etc.) reoccurs in the mandibular region. It does not have to be the same type or continuation of previous cancer; any cancer found within mandibular region postoperatively qualifies.	Patients will be monitored for 1 year post-operatively
Secondary	Adverse Events	Any additional complication or adverse event not covered by other secondary outcomes will be recorded from patient chart review and through a structured interview with the patients.	Charts and interviews reviewed at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)
Secondary	Occlusion	Extent of oral occlusion measured during in-person clinic assessments; can be recorded as normal occlusion, malocclusion Class I, malocclusion Class II, or malocclusion Class III.	Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)
Secondary	Jaw Mobility	Assessment of jaw freedom of movement will be taken during in-person clinic assessments; recorded as measurement of maximal mouth opening (millimeters) from top lip to bottom lip.	Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)