Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer (NAVI-LARRC)

• ClinicalTrials.gov Identifier: NCT04512937
• Recruitment Status: Recruiting
• First Posted: August 14, 2020
• Last Update Posted: June 22, 2021
• Sponsor: Oslo University Hospital
• Information provided by (Responsible Party): Kjersti Flatmark, Oslo University Hospital

Study Description

Brief Summary:

The aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. The investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer	Device: Computer-assisted navigation surgery	Not Applicable

Detailed Description:

Curative treatment of rectal cancer requires surgical removal of the tumour. The key challenge in this surgery is to remove the tumour with free margins - R0 resection. Failure to achieve R0 resection often leads to recurrence, which is associated with risk of long-term suffering, poor quality of life and death for the patients. Achieving R0 resection is most difficult in advanced rectal cancer cases, where the tumour is threatening - and sometimes even growing into - neighbouring organs.

Computer navigation-assisted surgery has typically been implemented where extreme surgical precision is necessary or in surgical fields with high anatomic complexity. In such settings, it contributes to preservation of vital anatomic structures close to the tumour, and ensures completeness of resection in cases of malignant disease.

With this in mind, feasibility of navigation in surgically challenging rectal cancer cases will be investigated in this study. If found feasible, navigation could improve surgical management for patients who otherwise would not have the possibility of cure.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: September 1, 2027
• Estimated Study Completion Date: September 1, 2027

Arms and Interventions

Arm

Intervention/treatment

Experimental: All patients; All patients will be subjects to the intervention of computer navigation-assisted surgery

Device: Computer-assisted navigation surgery; Computer navigation-assisted surgery has two main elements; the pre-procedural planning to create accurate 3D images of the pelvis allowing the surgical team to achieve an accurate perception of the operative field, and intraoperative navigation where these images are used for anatomical guidance to enhance surgical precision. Accordingly, computer software is used in this study to outline the tumour and other pelvic organs on pre-operative images which are subsequently used for intraoperative navigation.

Outcome Measures

Primary Outcome Measures :

1. Rate of patients with R0 resection [ Time Frame: 2 years ]
   Resection status will be determined by histopathological examination of specimen

Secondary Outcome Measures :

1. Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI). [ Time Frame: 2 years ]
   Postoperative MRI of the pelvis will be examined and compared to preoperative MRI to evaluate what structures were removed at surgery.
2. Assessment of whether pre-procedural plan was executed by comparing volume of intended resection with volume of resected specimen. [ Time Frame: 2 years ]
   Volume of intended resection (measured in millilitres) based on pre-procedural MRI will be comparted with volume of resected specimen (measured in millilitres).
3. Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews. [ Time Frame: 2 years ]
   Interviews with the surgeons will be semi-structured based on an interview guide. They will be recorded and transcribed, and analyzed using thematic analysis.
4. Occurrence of 30 day morbidity and mortality assessed with the Accordion severity grading system of surgical complications [ Time Frame: 30 days after surgery ]
   The Accordion severity grading system of surgical complications classifies surgical complications in 6 Levels ranging from mild complications (1) to Death (6)
5. Assessment of patients quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: 3 years ]
   The EORTC QLQ-C30 comprises 30 items (i.e. single questions) registering five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. EORTC QLQ C30 will be completed prior to surgery, and at one and three years after surgery. Changes over time will be analysed.
6. Overall survival (OS) [ Time Frame: 5 years ]
   OS is defined as time from surgery until death from any cause
7. Rate of local (re-)recurrence after surgery [ Time Frame: 5 years ]
   Local (re)-recurrence will be determined by routine follow-up
8. Progression-free survivial (PFS) [ Time Frame: 5 years ]
   PFS is defined as time from surgery until disease progression or death from any cause

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with LARC or LRRC (either biopsy verified, or demonstrated on MRI and confirmed by the MDT decision)
• The MDT must deem standard surgical strategy at high risk of resulting in R1/R2 resection and computer-assisted navigation likely to improve the chances of obtaining R0 resection.
• Written informed consent

Exclusion Criteria:

• Non-adenocarcinoma malignancies.
• Unresectable distant metastatic disease or unresectable synchronous other malignancy
• Patients deemed unfit to participation according to the MDT.

Contacts and Locations

Contacts

Contact: Arne M. Solbakken, MD; +47 48281082; armsol@ous-hf.no

Contact: Kjersti Flatmark, Professor; +47 91168466; kfm@ous-hf.no

Locations

Norway

Oslo University Hospital- The Norwegian Radium Hospital; Recruiting

Oslo, Norway, 0424

Contact: Kjersti Flatmark, MD PhD +4791168466 kfm@ous-hf.no

Principal Investigator: Kjersti Flatmark, Md PhD

Principal Investigator: Svein Dueland, MD PhD

Sub-Investigator: Stein G Larsen, MD PhD

Sub-Investigator: Ida S Froysnes, MD

Sponsors and Collaborators

Oslo University Hospital

Investigators

• Principal Investigator: Kjersti Flatmark, Professor; Oslo University Hospital

More Information

• Responsible Party: Kjersti Flatmark, Professor, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT04512937
• Other Study ID Numbers: 2020/123753
• First Posted: August 14, 2020
• Last Update Posted: June 22, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kjersti Flatmark, Oslo University Hospital:

Surgery, Computer-Assisted; Feasibility study

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases