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      Adverse events of NOTES mediastinoscopy compared to conventional video-assisted mediastinoscopy: a randomized survival study in a porcine model

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          Abstract

          Background: Safety is a concern in natural orifice transluminal endoscopic surgery (NOTES) mediastinoscopy. The objective of this study was to compare the safety of NOTES mediastinoscopy with video-assisted mediastinoscopy (VAM).

          Methods: Twenty-four pigs were randomly assigned to NOTES or VAM. Thirty-minute mediastinoscopies were performed with the identification of seven predetermined structures. The animals were euthanized after 7 days and necropsy was performed.

          Results: Mediastinoscopy was not possible in one animal in each group. There were more intraoperative adverse events with NOTES than VAM (7 vs. 2, P = 0.04); hemorrhage was the most frequent adverse event (4 and 1, respectively). At necropsy, pathological findings were observed in 13 animals (9 NOTES and 4 VAM; P = 0.03). Inflammatory parameters were not different between groups and were not related to adverse events.

          Conclusion: Systematic NOTES mediastinoscopy is possible and comparable to VAM in terms of number of organs identified and inflammatory impact. However, the safety profile of NOTES mediastinoscopy has to be improved before it can be adopted in a clinical setting.

          Most cited references17

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          Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia.

          P Pasricha, R Hawari, I. Ahmed … (2007)
          The most permanent method of treating achalasia is a surgical myotomy. Because of the requirement for a mucosal incision and the risk of perforation, this procedure has not generally been approached endoscopically. We hypothesized that we could perform a safe and robust myotomy by working in the submucosal space, accessed from the esophageal lumen. Four pigs were used for this experiment. Baseline lower esophageal sphincter (LES) pressures were recorded and the pigs underwent upper endoscopy using a standard endoscope. A submucosal saline lift was created approximately 5 cm above the LES and a small nick was made in the mucosa in order to facilitate the introduction of a dilating balloon. After dilation, the scope was introduced over the balloon into the submucosal space and advanced toward the now visible fibers of the LES. The circular layer of muscle was then cleanly incised using an electrocautery knife in a distal-to-proximal fashion, without complications. The scope was then withdrawn back into the lumen and the mucosal defect was closed with endoscopically applied clips. The entire procedure took less than 15 minutes. Manometry was repeated on day 5 after the procedure and the animals were euthanized on day 7. LES pressures fell significantly from an average of 16.4 mm Hg to an average of 6.7 mm Hg after the myotomy. The necropsy examinations revealed no evidence of mediastinitis or peritonitis. Endoscopic submucosal esophageal myotomy is feasible, safe, and effective in the short term. It has the potential for being useful in patients with achalasia. The submucosal space is a novel and potentially important field of operation for endoscopic procedures.
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            Endoscopic ultrasound with fine-needle aspiration in the diagnosis and staging of lung cancer.

            Gerard Silvestri, Brenda J Hoffman, Manoop S. Bhutani … (1996)
            Esophageal endoscopic ultrasonographic (EUS) guidance for fine-needle aspiration (FNA) of mediastinal lymph nodes has been introduced only recently. The utility of EUS/FNA in diagnosing and staging bronchogenic carcinoma is unknown. After a thoracic computed tomographic scan, 27 patients with known or suspected lung cancer underwent EUS. Accessible abnormal mediastinal lymph nodes were aspirated under EUS guidance. Patients with positive cytologic studies did not undergo further testing, whereas the remaining patients underwent mediastinal exploration. The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were calculated for both chest computed tomography and EUS/FNA: Twenty-two of 27 patients had mediastinal adenopathy by computed tomography scan. Sixteen patients had positive findings on EUS, 15 with positive FNA (10 non-small cell lung cancer; 5 small cell lung cancer) and 1 with T4 status. Fourteen patients with positive FNA had lymph nodes sampled at level 5, level 7, or both. Of 11 patients with negative EUS/FNA, 2 had positive findings at operation (sensitivity 89%). The diagnosis of lung cancer was established in 7 patients. The results showed that EUS/FNA improves the accuracy of computed tomographic scan in the staging of lung cancer. By accessing lymph nodes at levels 5 and 7, EUS/FNA complements mediastinoscopy and is considered the staging modality of choice in these regions. Positive EUS/FNA can obviate the need for further invasive staging.
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              Transesophageal mediastinoscopy by submucosal endoscopy with mucosal flap safety valve technique.

              Elizabeth Rajan, Kazuki Sumiyama, Mary Knipschield … (2007)
              Indications for NOTES (natural orifice transluminal endoscopic surgery) studied so far are limited to intra-abdominal surgery. To determine the technical feasibility and the safety of transesophageal mediastinocosopy by using the submucosal endoscopy with mucosal flap safety valve (SEMF) technique. Two-week survival study with 4 porcine models. High-pressure carbon dioxide injection and balloon dissection created a large submucosal working space for insertion of a cap-fitted endoscope. The muscularis propria was resected inside the submucosal space, and the mediastinoscopy was performed by using the endoscope inserted via the myotomy site. The muscular defect was sealed with the overlying mucosal flap, and the mucosal entry site was closed with clips. Repeated endoscopy and necropsy were performed 2 weeks after the procedure. With the SEMF technique, the posterior mediastinum was successfully accessed in all animals. Three pigs survived 2 weeks without clinical complications, and the defects were completely sealed by the mucosal flap. One pig with proximal esophageal mediastinal entry managed under voluntary respiration was euthanized because of pleural injury. The SEMF technique provided safe entry into the mediastinum, with a protective submucosal tunnel that prevented mediastinal soiling. Mid to distal esophageal access is safer than the higher level access. Mechanical ventilation might allow safer respiratory support.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Endosc Int Open
                Journal ID (iso-abbrev): Endosc Int Open
                Journal ID (publisher-id): 10.1055/s-0034-1377934
                Title: Endoscopy International Open
                Publisher: © Georg Thieme Verlag KG (Stuttgart · New York )
                ISSN (Print): 2364-3722
                ISSN (Electronic): 2196-9736
                Publication date (Print): December 2015
                Publication date (Electronic): 11 August 2015
                Volume: 3
                Issue: 6
                Pages: E571-E576
                Affiliations
                [1 ]Department of Gastroenterology, Hospital Clínic, University of Barcelona, Barcelona, Spain
                [2 ]Anesthesiology Department, Hospital Clínic, University of Barcelona, Barcelona, Spain
                [3 ]Department of Thoracic Surgery, Hospital Clínic, University of Barcelona, Barcelona, Spain
                Author notes
                Corresponding author G. Fernández-Esparrach, MD PhD Department of Gastroenterology ICMDiM Hospital Clínic Villarroel 17008036 BarcelonaSpain+34-93-2279387 mgfernan@ 123456clinic.ub.es
                Article
                DOI: 10.1055/s-0034-1392599
                PMC ID: 4683132
                SO-VID: 3dee83d5-ed72-4402-aa19-846cb54fe623
                Copyright © © Thieme Medical Publishers
                History
                Date received : 23 March 2015
                Date accepted : 16 June 2015
                Categories
                Subject: Article

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