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Endoscopic Radiofrequency Ablation in Colorectal Cancer: Initial Clinical Results of a New Bipolar Radiofrequency Ablation Device
Vavra, Petr M.D.1,2; Dostalik, Jan M.D.2; Zacharoulis, Dimitris M.D.1,3; Khorsandi, Shirin E. M.D.1; Khan, Shahid A. M.D.1; Habib, Nagy A. M.D.1,4 Volume 52(2),February 2009,pp 355-358 [TECHNICAL NOTES] The ASCRS 2009
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Author(s):

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Department of Biosurgery and Surgical Technology, Imperial College London, London, United Kingdom Department of Surgery, University Hospital Ostrava, Ostrava, Czech Republic Department of Surgery, University Hospital of Larissa, Larissa, Greece EMcision Ltd, London, United Kingdom Endoblate was provided free of charge by EMcision Ltd., London, United Kingdom. Presented at the meeting of the Association of Surgeons of Great Britain and Ireland, Bournemouth, United Kingdom, May 14 to 16, 2008. Address of correspondence: Nagy A. Habib, M.D., Head of Biosurgery and Biotechnology, Imperial College, Hammersmith Hospital, Du Cane Road, London W12 0NN, United Kingdom. E-mail: nagy.habib@imperial.ac.uk
DOI: 10.1007/DCR.0b013e31819a3e09 ISSN: 0012-3706 Accession: 00003453-200902000-00029 Full Text (PDF) 1369K

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Institution(s):

Keywords: Radiofrequency ablation, Rectosigmoid, Cancer, Endoluminal

Abstract
PURPOSE: There are a number of alternative approaches to palliate cancers of the rectosigmoid, which may not be well tolerated or produce effective symptom relief. Therefore, there is a continuing need to develop alternative techniques for palliation. This paper reports our initial assessment of a new bipolar radiofrequency probe (Endoblate). METHODS: Twelve patients with rectosigmoid tumors were treated with Endoblate during transanal endoscopic microsurgery. In ten patients, this was followed by surgical resection and two patients were treated with Endoblate alone. This study was designed to assess the technical utility of the device, immediate complications, and histologic effect.

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RESULTS: There were no technical problems. In the patients who had resection of the tumor immediately after ablation (n = 10), there were no local complications evident at surgery. Histology of the resected specimens showed that, on average, 82 (range, 60-99) percent of the tumor mass was destroyed in the ablation zone. In the remaining two patients, Endoblate alone was used successfully to stop bleeding from the tumor. CONCLUSIONS: These preliminary results illustrate the evolution and endoscopic application of bipolar radiofrequency technology. Endoblate showed potential as a useful and safe tool for the palliation of lower gastrointestinal malignancy.

The ideal management of patients with rectal or low sigmoid colon cancers is surgical resection; however, in 20 to 30 percent of patients, local tumor advancement, metastatic disease, or patient's comorbidity, prevent curative resection from being undertaken.1 As the local disease progresses, these patients often need palliation of symptoms, such as bleeding, obstruction, rectal urgency, or tenesmus, to improve their quality of life. A number of different endoscopic techniques have been used to palliate tumors of the rectosigmoid, such as neodymium:yttrium-argon-garnet (Nd:YAG) laser vaporization, argon plasma coagulation, electrocoagulation, and cryotherapy.2,3 Alternatively, in selected patients, endoscopic metal stents can be used for long-term palliation. These alternative therapies, as well as palliating symptoms, may then be combined with systemic chemotherapy or radiotherapy to further aid in local tumor control, as well as to provide additional symptom palliation.4 During the last decade, there has been a major interest in using radiofrequency (RF) energy to destroy solid tumors in situ,5 with RF ablation becoming a standard therapeutic option for primary and secondary cancers of the liver, when surgery cannot been undertaken.6-8 This approach to cancer management is a rapidly expanding field, with the total number of thermal ablation procedures performed in the United States predicted to grow from an estimated 47,600 in 2005 to 135,000 procedures in 2010.9 Endoscopic RF ablation has not been used previously for the palliation of colorectal cancers. This study reports our initial experience of the endoscopic application of a novel bipolar RF probe in the ablation of low rectosigmoid tumors, focusing on the device's technical utility, immediate complications, and histologic effect.

PATIENTS AND METHODS

Description of Device and Operative Procedure
Endoluminal ablation of rectosigmoid tumors was performed with a newly designed bipolar RF probe (Endoblate, EMcision Ltd., London, United Kingdom). The only financial support from the manufacturer was that the devices were provided free of charge. The device consists of three contact electrodes and one ring electrode, which is activated by bipolar RF energy, so that no grounding pads need to be applied to the patient (Fig. 1). The probe can be used with two alternative RF generators: Radionics Cosman Coagulator CC-1 or RITA 1500. The probe is designed to be introduced through the working channel of an endoscope or via an operating proctoscope during transanal endoscopic microsurgery (TEM). In the present study, all Endoblate sessions were performed during TEM under general anesthesia.

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FIGURE 1. Close-up of the Endoblate probe. The Endoblate catheter was introduced through the instrument channel of the operating proctoscope during TEM (Fig. 2), ensuring that the three contact electrodes were in the retracted position. Under endoscopic visualization, the distal tip of Endoblate was advanced so that the end of the device lay in contact with the area of tumor to be treated. Using the handle mechanism of Endoblate, the electrodes were advanced into the tumor to a depth of 2 to 3 mm. The RF generator was then activated and power output was kept as low as possible to achieve therapeutic effect, initially 1 watt (W), increasing to 4 W, if required. The RF energy was delivered to the target area of the tumor, until an impedance increase of 10 percent was observed, indicating that in the target tumor area, sufficient coagulation had been produced. The RF generator was then placed in standby mode and the three electrodes of Endoblate retracted. Endoscopic ultrasound (EUS) was then performed to assess depth of ablation in relation to tumor thickness, to minimize the risk of perforation during the procedure. After each application of Endoblate, a well-demarcated ablation zone was visible endoscopically and the probe was reapplied step by step to produce a confluent area of RF ablation (Fig. 3).

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FIGURE 2. Endoblate catheter being introduced through the instrument channel of the operating proctoscope during transanal endoscopic microsurgery (TEM).

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FIGURE 3. Transanal endoscopic microsurgery (TEM) showing the Endoblate probe being applied to a rectal tumor to produce ablation. When technically feasible, the ablated tumor was then resected at open or laparoscopic operation. This allowed both immediate (intraoperative) assessment of the local complications and subsequent histologic assessment of Endoblate to be performed.

Patients
The application of Endoblate was assessed in 12 patients with lower rectosigmoid malignancies. All patients underwent preoperative assessment of their disease (history, clinical examination, and relevant investigations). Patients selected for inclusion in this study had a tumor of the rectosigmoid and had given informed consent. The decision not to perform curative or palliative resection after tumor ablation was based on the patient's fitness to tolerate a surgical resection. In each case, suitability for the use of Endoblate for ablation alone or ablation followed by surgical resection was discussed at a multidisciplinary team meeting. Local ethics approval was obtained and the Declaration of Helsinki was adhered to throughout. Data collected for each patient included tumor details (TNM staging) and level of fitness using the American Society of Anesthesiology classification (ASA). Before ablation, EUS of the tumor was performed to document its thickness and length. Procedural data collected included power requirements (W), procedure time (defined as the time from insertion of the endoscope to completion of ablation), and ablation time (time from insertion of the ablation catheter to its removal). Any Endoblate related complications were recorded and all patients were followed up three weeks after the procedure with a full clinical assessment.

RESULTS
Patient Demographics, Tumor Characteristics, and Procedural Data
Twelve patients (median age 70.4 (range, 54-82) years) were treated with Endoblate. One patient underwent tumor ablation on two occasions for palliation of bleeding. Table 1 summarizes the clinicopathologic characteristics

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of the treated patients.

TABLE 1. Clinicopathologic data for patients treated with Endoblate On endoscopic ultrasound assessment of the tumor before ablation, the median distance of tumors from the anal verge was 7.2 (range, 0.7-15) cm, the median tumor thickness was 3.1 (range, 2.3-4.1) cm, and the median tumor length was 4 (range, 3-6) cm. The mean total procedure and ablation time were 40 (range, 11-65) minutes and 17 (range, 1-45) minutes, respectively. The average power setting used for ablation was 2.7 (range, 1-4) W.

Endoblate Procedural Morbidity and Mortality

Under the same general anesthestic, surgical resection was performed after endoluminal ablation in ten patients. Only two patients were managed by endoluminal ablation alone to manage the symptom of bleeding. In one of these latter patients, a planned repeat Endoblate treatment was performed 20 days after the initial session. Surgical procedures undertaken were TEM (n = 3), abdominoperineal excision (n = 3: 2 laparoscopic and 2 open), and anterior resection (n = 4: 2 laparoscopic and 2 open). At operation, there was no evidence of transmural thermal injury, pericolic fluid, or any other adverse findings, such as bowel perforation, after endoluminal ablative therapy. On macroscopic inspection of the resected specimen, the ablation zone was sharply demarcated from tissue where no ablation had been performed. No patient required a blood transfusion, and there was no endoluminal ablation treatment-related mortality or morbidity during inpatient stay or during the three weeks of follow-up after discharge. In relation to the operative

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procedures undertaken, there were two complications: one wound infection and one pneumonia. Overall, the median length of stay was 8.4 (range, 3-12) days. In the two patients who underwent ablation only, the average length of stay was 3.5 days.

Follow-Up Data
Histologic assessment of the resected specimen after Endoblate therapy showed that, on average, 82 (range, 60-99) percent of the tumor mass was destroyed in the ablation zone (Fig. 4). In the two patients who had only been treated with Endoblate (for the symptom of bleeding) and not undergone surgical resection, there were no delayed complications relating to endoluminal RF ablation, nor were there any recurrent symptoms of bleeding at clinical assessment three weeks following discharge.

FIGURE 4. Hematoxylin and eosin stain (magnification 20) of resected rectal tumor after ablation showing the histologic effect of Endoblate on the rectal tumor. An area of demarcation necrosis has been produced by Endoblate, which lies to the right of the marked line, highlighted by an asterisk.

DISCUSSION
Various strategies, such as diverting colostomy, radiotherapy, chemotherapy, self-expanding metal stents, and endoscopic ablative therapy, have been used to palliate tumors of the rectosigmoid.1-4 These approaches are not always well tolerated by the patient and neither do they consistently produce effective symptom relief. Therefore, there is a need to develop and explore alternative approaches for palliation in patients for whom surgical resection of the primary rectosigmoid tumor is not feasible or appropriate. RF energy is emerging as a safe and effective technique to ablate solid tumors.4,6,7 However, the utility of RF energy to palliate tumors of the lower gastrointestinal tract has not been previously explored. Based on our experience of RF in the management of liver cancer, we have developed Endoblate, a bipolar RF probe designed to ablate endoluminal lesions via the endoscope or operating proctoscope.

CONCLUSIONS

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This preliminary study demonstrated that endoscopic application of bipolar RF ablative technology with Endoblate may hold promise for palliation of patients with widely metastatic or unresectable symptomatic rectal cancer. Based on our findings, we recommend that further and larger studies, including controlled trials, are performed to compare this technology with other palliative techniques.

REFERENCES
1. Baigrie RJ, Berry AR. Management of advanced rectal cancer. Br J Surg 1994;81:343-52. ExternalResolverBasic Full Text Bibliographic Links [Context Link] 2. Kiran RP, Pokala N, Burgess P. Use of laser for rectal lesions in poor-risk patients. Am J Surg 2004;188:708-13. ExternalResolverBasic Full Text Bibliographic Links [Context Link] 3. Kimmey MB. Endoscopic methods (other than stents) for palliation of rectal carcinoma. J Gastrointest Surg 2004;8:270-3. ExternalResolverBasic Full Text Bibliographic Links [Context Link] 4. Karoui M, Charachon A, Delbaldo C, et al. Stents for palliation of obstructive metastatic colon cancer: impact on management and chemotherapy administration. Arch Surg 2007;142:619-23. ExternalResolverBasic Full Text Bibliographic Links [Context Link] 5. Ohhigashi S, Watanabe F. Radiofrequency ablation is useful for selected cases of pelvic recurrence of rectal carcinoma. Tech Coloproctol 2003;7:186-91. ExternalResolverBasic Full Text Bibliographic Links [Context Link] 6. Jiao LR, Hansen PD, Havlic R, et al. Clinical short-term results of radiofrequency ablation in primary and secondary liver tumors. Am J Surg 1999;177:303-6. ExternalResolverBasic Full Text Bibliographic Links [Context Link] 7. Navarra G, Ayav A, Weber JC, et al. Short- and-long term results of intraoperative radiofrequency ablation of liver metastases. Int J Colorectal Dis 2005;20:521-8. [Context Link] 8. Mulier S, Mulier P, Ni Y, et al. Complications of radiofrequency coagulation of liver tumors. Br J Surg 2002;89:1206-22. [Context Link] 9. U.S. Markets for Electrosurgical and Thermal Ablation Products Report. MedTech Insight #A556 July 2006 Chapter 4. Available at: http://www.medtechinsight.com/reports.html . Accessed July 16, 2008. [Context Link] KEY WORDS: Radiofrequency ablation; Rectosigmoid; Cancer; Endoluminal

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