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Surgical navigation for targeted retroperitoneal lymph-node removal: a randomised, controlled, phase 3 trial
Harald C Groen1, Esther M K Wit2, Wouter J Heerink1
1Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Background:
Metastatic retroperitoneal lymph node dissection (LND) for nodal recurrence is applied for a variety of cancers, such as urological, gynaecological and rectal cancer. Precise localisation and resection of these lymph nodes (LNs) during surgery can be challenging, especially after previous radiotherapy or surgery. The objective of this study was to assess the added value of surgical navigation for targeted LND in the retroperitoneum.
Methods:
We performed an open-label randomised, controlled, phase 3 trial at the Netherlands Cancer Institute, Amsterdam. Eligible participants were over 18 years of age, scheduled for targeted retroperitoneal LND by laparotomy, with removal of one or more suspected (targeted) LN(s) as assessed by diagnostic imaging. Patients were randomised (1:1) between conventional LND and LND using surgical navigation, by means of a minimisation method stratified for tumour origin (urological, colorectal and other). For the surgical navigation, a digital 3D model of the patients' anatomy was created from diagnostic CT scans, including delineation of the targeted LN(s). The 3D model was linked to the patients' position in the operation room. Using an electromagnetic tracking system, with a sterile tracked pointer, the actual position of the pointer was shown in the 3D model, enabling the surgeon to localize the targeted LN(s). The primary outcome of the study was the percentage of successful procedures. Success was defined as no residual target LN(s) visible on postoperative CT imaging. This study was registered with ClinicalTrials.gov, NCT05867095.
Findings:
From January 2017 to December 2020, 69 participants were included in the study, 35 (51%) in the conventional arm and 34 (49%) in the navigation arm. Four patients were not evaluable and excluded from further analysis; three in the conventional arm (patients withdraw from study participation), one in the navigation arm (discontinued surgery, misclassified diagnosis). According to intention-to-treat analysis, 50% (16/32) of the surgical procedures was successful in the conventional arm, versus 85% (28/33) in the surgical navigation arm (one-tailed p = 0.0028, 90% CI: 14%-56%). Using the Clavien-Dindo classification, the overall complication rate was comparable between the conventional arm and the navigation arm. Surgeons judged the surgical navigation setup as valuable, the median preference score to use surgical navigation was 3.7 (3.3-4.0) (scale 1-5), and the median system usability score was 75 (70-85) (scale 0-100).
Interpretation:
Surgical navigation allows for significantly better localisation and removal of target LN(s) in the retroperitoneum.
Funding:
This research was supported by the KWF-Alpe d'HuZes (NKI 2014-6596) and by an institutional grant of The Dutch Cancer Society and of the Dutch Ministry of Health, Welfare and Sport.
Insights
Surgical navigation significantly improves the success rate of retroperitoneal lymph node dissection (LND) for cancer recurrence. This advanced technique enhances the precise removal of targeted lymph nodes (LNs), leading to better patient outcomes.
Area of Science:
- Oncology
- Surgical Technology
- Medical Imaging
Background:
- Metastatic retroperitoneal lymph node dissection (LND) is crucial for managing nodal recurrence in various cancers, including urological, gynaecological, and rectal types.
- Precise localization and resection of retroperitoneal lymph nodes (LNs) can be challenging, particularly after prior radiotherapy or surgery.
- Assessing the added value of surgical navigation for targeted LND in the retroperitoneum is essential for improving surgical efficacy.
Purpose of the Study:
- To evaluate the effectiveness of surgical navigation in improving the success rate of targeted retroperitoneal lymph node dissection (LND).
- To compare the outcomes of LND performed with surgical navigation versus conventional methods in patients with suspected nodal recurrence.
Main Methods:
- A phase 3, open-label, randomised controlled trial was conducted involving patients scheduled for targeted retroperitoneal LND.
- Patients were randomised to receive either conventional LND or LND using surgical navigation, which involved creating a 3D anatomical model from CT scans.
- Success was defined as the absence of residual target lymph nodes on postoperative CT imaging.
Main Results:
- The success rate for surgical procedures was significantly higher in the navigation arm (85%) compared to the conventional arm (50%) (p=0.0028).
- The overall complication rates were comparable between the two groups, as assessed by the Clavien-Dindo classification.
- Surgeons reported a positive perception of surgical navigation, with a median preference score of 3.7 and a median system usability score of 75.
Conclusions:
- Surgical navigation offers a significant advantage in the precise localization and removal of target lymph nodes in the retroperitoneum.
- The integration of surgical navigation technology enhances the efficacy of LND procedures for cancer recurrence.
- This technology holds promise for improving surgical outcomes in managing metastatic retroperitoneal lymph nodes.
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