Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology

NCT07466810 | Not Yet Recruiting

• 1 other identifier: SH9H-2024-T403-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site. Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality \[MR\] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.

Conditions

Tongue Squamous Cell Carcinoma; Mixed Reality; Virtual Surgical Planning; Free Flap; Oral Cancer

Keywords

Mixed Reality; tongue reconstruction; Unreal Engine 5; Glossectomy; Surgical guide; Free Flap; Virtual Surgical Planning; Oral Cancer

Outcome Measures

Primary Outcomes (1)

• Morphological and Volumetric Matching Degree of Free Flap Reconstruction

  Description: Computed Tomography (CT) scans will be performed at 1 month and 6 months postoperatively. CT data will be fused with the preoperative design scheme to calculate morphological similarity (expressed as a percentage), so as to evaluate the morphological and volumetric matching effect between the reconstructed flap and the defect site in the three groups. The core purpose is to compare the precision of MR technology with the other two methods.

  Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively

Secondary Outcomes (2)

• Surgery-related Indicators

  Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively

• Postoperative Recovery Indicators

  Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively

Study Arms (3)

Control Group (Conventional Surgery)

NO INTERVENTION

Adoption of traditional surgical methods for oral cancer resection and defect repair; no auxiliary technologies such as mixed reality or virtual guides are used, and tumor resection and flap repair are completed relying on the clinician's clinical experience.

Experimental Group 1 (Mixed Reality Technology)

EXPERIMENTAL

Application of Mixed Reality (MR) technology based on the UE5 engine to assist in oral cancer resection and defect repair; realize real-time three-dimensional visualization of surgical plans, precise resection of oral cancer, "tailor-made" flap harvesting, and match the shape and volume of the defect site.

Procedure: Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction

Experimental Group 2 (Virtual Surgical Guide)

EXPERIMENTAL

Application of virtual surgical guide technology to assist in oral cancer resection and defect repair; assist surgery relying on pre-designed and manufactured guides to improve surgical standardization; guide printing is required before surgery, and the plan cannot be adjusted in real time during surgery.

Procedure: Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction

Interventions

Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction PROCEDURE

Intervention Description: Assisted oral cancer resection and defect reconstruction using MR technology based on UE5 engine, to achieve real-time stereoscopic visualization of surgical planning, accurate tumor resection and personalized free flap harvest, ensuring the reconstructed flap matches the defect site in morphology and volume.

Experimental Group 1 (Mixed Reality Technology)

Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction PROCEDURE

Intervention Description: Assisted oral cancer resection and defect reconstruction using virtual surgical guide technology, with surgery performed under the guidance of preoperatively designed and fabricated guides to improve surgical standardization.

Experimental Group 2 (Virtual Surgical Guide)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite pathological diagnosis of oral cancer before surgery;
• Defects suitable for free flap reconstruction;
• Patients have signed the informed consent form and are willing to cooperate with postoperative follow-up.

You may not qualify if:

• \- Poor general condition, evaluated as unable to tolerate surgical treatment.
• Subjects who have been enrolled in this trial will be excluded if they meet any of the following conditions:
• Subjects did not receive surgical treatment;
• No observation data after randomization. Withdrawal Criteria Withdrawal of subjects from the trial refers to cases where enrolled subjects are determined by the investigator to withdraw from the trial due to conditions that make it inappropriate to continue the trial. In accordance with the informed consent form, subjects have the right to withdraw from the trial midway. Subjects who do not explicitly propose to withdraw but stop receiving treatment and tests and are lost to follow-up are also considered "withdrawn" (or "lost to follow-up"). The reason for withdrawal should be understood and recorded as much as possible, such as: poor subjective curative effect; inability to tolerate certain adverse reactions; inability to continue participating in the clinical study due to personal reasons; economic factors; or lost to follow-up without stating the reason.
• (1) Aggravation or deterioration of the condition during the trial that requires emergency measures; (2) Occurrence of certain comorbidities, complications or special physiological changes in subjects during the trial, making it inappropriate to continue participating in the trial; (3) Voluntary withdrawal by the subject.
• Data Handling of Withdrawn Subjects
• Regardless of the reason, the complete clinical data of subjects who withdraw from the trial shall be retained. For all withdrawn subjects, the trial conclusion form and the reason for withdrawal shall be filled in the case report form (CRF). Generally, there are 6 types of reasons: occurrence of adverse events (including adverse drug reactions and allergic reactions), lack of efficacy (deterioration of condition or occurrence of complications), violation of the trial protocol (including poor compliance), lost to follow-up (including voluntary withdrawal by the patient), termination by the sponsor, or others.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, China

Location

Related Publications (13)

• Joo YH, Hwang SH, Park JO, Cho KJ, Kim MS. Functional outcome after partial glossectomy with reconstruction using radial forearm free flap. Auris Nasus Larynx. 2013 Jun;40(3):303-7. doi: 10.1016/j.anl.2012.07.012. Epub 2012 Aug 10.

  PMID: 22884635 BACKGROUND

• Chien CY, Su CY, Hwang CF, Chuang HC, Jeng SF, Chen YC. Ablation of advanced tongue or base of tongue cancer and reconstruction with free flap: functional outcomes. Eur J Surg Oncol. 2006 Apr;32(3):353-7. doi: 10.1016/j.ejso.2005.12.010. Epub 2006 Feb 7.

  PMID: 16455224 BACKGROUND

• Sakuraba M, Asano T, Miyamoto S, Hayashi R, Yamazaki M, Miyazaki M, Ugumori T, Daiko H, Kimata Y. A new flap design for tongue reconstruction after total or subtotal glossectomy in thin patients. J Plast Reconstr Aesthet Surg. 2009 Jun;62(6):795-9. doi: 10.1016/j.bjps.2007.09.056. Epub 2008 Apr 29.

  PMID: 18448406 BACKGROUND

• Forner D, Phillips T, Rigby M, Hart R, Taylor M, Trites J. Submental island flap reconstruction reduces cost in oral cancer reconstruction compared to radial forearm free flap reconstruction: a case series and cost analysis. J Otolaryngol Head Neck Surg. 2016 Feb 5;45:11. doi: 10.1186/s40463-016-0124-8.

  PMID: 26846792 BACKGROUND

• Valentini V, Cassoni A, Marianetti TM, Battisti A, Terenzi V, Iannetti G. Anterolateral thigh flap for the reconstruction of head and neck defects: alternative or replacement of the radial forearm flap? J Craniofac Surg. 2008 Jul;19(4):1148-53. doi: 10.1097/SCS.0b013e3181764ad6.

  PMID: 18650750 BACKGROUND

• Wu JC, Huang JJ, Tsao CK, Abdelrahman M, Kolios G, Cheng MH. Comparison of Posteromedial Thigh Profunda Artery Perforator Flap and Anterolateral Thigh Perforator Flap for Head and Neck Reconstruction. Plast Reconstr Surg. 2016 Jan;137(1):257-266. doi: 10.1097/PRS.0000000000001880.

  PMID: 26371390 BACKGROUND

• Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.

  PMID: 22337427 BACKGROUND

• Bai S, Shang H, Liu Y, Zhao J, Zhao Y. Computer-aided design and computer-aided manufacturing locating guides accompanied with prebent titanium plates in orthognathic surgery. J Oral Maxillofac Surg. 2012 Oct;70(10):2419-26. doi: 10.1016/j.joms.2011.12.017. Epub 2012 Apr 18. No abstract available.

  PMID: 22516840 BACKGROUND

• Kumar BP, Venkatesh V, Kumar KA, Yadav BY, Mohan SR. Mandibular Reconstruction: Overview. J Maxillofac Oral Surg. 2016 Dec;15(4):425-441. doi: 10.1007/s12663-015-0766-5. Epub 2015 Apr 19.

  PMID: 27833334 BACKGROUND

• Chang EI, Boukovalas S, Liu J, Largo RD, Hanasono MM, Garvey PB. Reconstruction of Posterior Mandibulectomy Defects in the Modern Era of Virtual Planning and Three-Dimensional Modeling. Plast Reconstr Surg. 2019 Sep;144(3):453e-462e. doi: 10.1097/PRS.0000000000005954.

  PMID: 31461040 BACKGROUND

• Foley BD, Thayer WP, Honeybrook A, McKenna S, Press S. Mandibular reconstruction using computer-aided design and computer-aided manufacturing: an analysis of surgical results. J Oral Maxillofac Surg. 2013 Feb;71(2):e111-9. doi: 10.1016/j.joms.2012.08.022. Epub 2012 Nov 17.

  PMID: 23164998 BACKGROUND

• Deek NFAL, Wei FC. Computer-Assisted Surgery for Segmental Mandibular Reconstruction with the Osteoseptocutaneous Fibula Flap: Can We Instigate Ideological and Technological Reforms? Plast Reconstr Surg. 2016 Mar;137(3):963-970. doi: 10.1097/01.prs.0000479998.49928.71.

  PMID: 26910680 BACKGROUND

• Koumoullis H, Burley O, Kyzas P. Patient-specific soft tissue reconstruction: an IDEAL stage I report of hemiglossectomy reconstruction and introduction of the PANSOFOS flap. Br J Oral Maxillofac Surg. 2020 Jul;58(6):681-686. doi: 10.1016/j.bjoms.2020.04.017. Epub 2020 Apr 27.

  PMID: 32349901 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• mingming lv, Associate Professor

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mingming Lv

CONTACT

86+13818448654; lvmingming001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)