Silvana Perretta

Natural Orifice Transluminal Endoscopic Surgery: Transgastric Cholecystectomy in a survival porcine model

Beyond doubt, laparoscopic cholecystectomy has changed the focus of surgery and the mind-set of nearly all surgeons. For this reason, the initial natural orifices translumenal endoscopic surgery (NOTES) project focused on cholecystectomy, which seemed to be the most logical and appealing clinical application. The first reports on cholecystectomy confirmed the feasibility of NOTES but identified substantial technical limits because of exposure, endoscope stability issues, and limitations in the control of dissection tools [1, 2]. These limitations led to experimentation with other natural orifice accesses: the colon, the urinary bladder, and combined routes [3, 4]. Although transcolonic cholecystectomy has been reported in survival studies, to date, the feasibility of transgastric cholecystectomy has been described only in nonsurvival animal models [1, 2, 5]. We report the successful performance of transgastric cholecystectomy with survival in a porcine model.

Challenges and lessons learned from NOTES cholecystectomy initial experience: a stepwise approach from the laboratory to clinical application

BACKGROUND/PURPOSEnThe initial idea behind natural orifice transluminal endoscopic surgery (NOTES) was that of an incisionless surgery. NOTES cholecystectomy is a good model of human ingenuity and technological advance. NOTES cholecystectomy in a human being was performed at our institution after extensive laboratory work in live pig models. In this process we gained helpful information related to NOTES cholecystectomy.nnnMETHODSnMore than 250 cholecystectomies in pigs have been performed. From May 2007 to November 2008 a total of 10 and 6 transvaginal and transgastric human cholecystectomies, respectively, have been performed.nnnRESULTSnThe procedure was successful in all patients, with a mean operative time of 120 min. There were no intraoperative or postoperative complications. Patients recovered promptly after surgery and had minor postoperative pain. They were discharged on the second postoperative day.nnnCONCLUSIONSnThe advantages of laparoscopy appeared to be enhanced by this approach: patients had minor postoperative pain and minimal scarring. This stepwise experience in the cholecystectomy procedure is an important first step in the development of methods and devices to enable the evaluation of potential incisionless NOTES surgery. Additional research and comparison studies are needed for further improvement in order to provide NOTES procedures to a wider range of patients.

Transanal rectosigmoid resection via natural orifice translumenal endoscopic surgery (NOTES) with total mesorectal excision in a large human cadaver series

BackgroundThe authors’ group has previously described successful transanal rectosigmoid resection via natural orifice translumenal endoscopic surgery (NOTES) in both porcine and cadaveric models using the transanal endoscopic microsurgery platform. This report describes the largest cadaveric series to date as optimization of this approach for clinical application continues.MethodsBetween December 2008 and September 2011, NOTES transanal rectosigmoid resection with total mesorectal excision (TME) was successfully performed in 32 fresh human cadavers using transanal dissection alone (nxa0=xa019), with transgastric endoscopic assistance (nxa0=xa05), or with laparoscopic assistance (nxa0=xa08). The variables recorded were gender, body mass index (BMI), operative time, length of the mobilized specimen, integrity of the mesorectum and the resected specimen, and complications. Univariate statistical analysis was performed.ResultsOf the 32 cadavers, 22 were male with a mean BMI of 24xa0kg/m2 (range 16.3–37xa0kg/m2). The mean operative time was 5.1xa0h (range 3–8xa0h), and the mean specimen length was 53xa0cm (range 15–91.5xa0cm). After the first five cadavers, specimen length significantly improved, and a trend toward decreased operative time was demonstrated. The mesorectum was intact in 100xa0% of the specimens. In nine cadavers, endoscopic dissection was complicated by organ injury. Evaluation by the operative approach demonstrated a significantly longer specimen with laparoscopic assistance (67.7xa0cm) than with transgastric assistance (45.4xa0cm) or transanal dissection alone (49.2xa0cm) (pxa0=xa00.013). Comparison of the technique used for inferior mesenteric pedicle division demonstrated both significantly decreased operative time (4.8 vs 6xa0h; pxa0=xa00.024) and increased specimen length (57.7 vs 39.6xa0cm; pxa0=xa00.025) when a stapler was used in lieu of a bipolar cautery device.ConclusionTransanal NOTES rectosigmoid resection with TME is feasible and demonstrates improvement in specimen length and operative time with experience. Transitioning to clinical application requires laparoscopic assistance to overcome limitations related to NOTES instrumentation, as well as procedural training with fresh human cadavers.

The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report

BackgroundThe EURO-NOTES Clinical Registry (ECR) was established as a European database to allow the monitoring and safe introduction of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The aim of this study was to analyze different techniques applied and relative results during the first 2xa0years of the ECR.MethodsThe ECR was designed as a voluntary database with online access. All members of the European Society for Gastrointestinal Endoscopy and the European Association for Endoscopic Surgery were requested to participate in the registry. Demographic and therapy data as well as data on the postoperative course are recorded in the ECR in an anonymous way.ResultsA total of 533 patients who underwent NOTES procedures were included in the study. Four different hybrid techniques for 435 cholecystectomies were described, registering postoperative complications in 2.8xa0% of patients, addition of a single trocar in 5.3xa0%, and conversions to laparoscopy in 0.5xa0%. Both flexible endoscopic and rigid laparoscopic cholecystectomy techniques proved to be safe and effective with minor differences. There was a shorter operative time in the rigid laparoscopic group. Thirty-three appendectomies were reported by transgastric and transvaginal techniques, with transvaginal techniques scoring shorter operative time and hospital stay, but with a frequent need to add more trocars. Overall complications occurred in 14.7xa0% of patients but they did not differ significantly among the different techniques. One transvaginal and 31 transanal sigmoidectomies were included for prolapse and diverticulitis, with four postoperative complications (12.5xa0%), but none needing further treatment. Twenty peroral esophageal myotomies were included with three postoperative complications (15.0xa0%), but none needing further treatment.ConclusionsFive years since the introduction of NOTES into clinical practice, hybrid techniques have gained considerable clinical application. Several NOTES hybrid cholecystectomy and appendectomy techniques are practicable and safe alternatives to laparoscopic procedures. Also, sigmoidectomies and peroral esophageal myotomies were described, proving feasibility and safety. Nevertheless, the real benefit of NOTES for patients still needs to be assessed.

Gastric lymphatic mapping for sentinel node biopsy by natural orifice transluminal endoscopic surgery (NOTES)

BackgroundSentinel node biopsy is proposed as sufficiently reliable in determining the lymph node status of early gastric cancer to justify curtailed resection margins if negative. Its performance by natural orifice transluminal endoscopic surgery (NOTES) could therefore expand the patient cohort able to undergo solely endoscopic resection of their primary.MethodsA transvaginal NOTES technique was utilized in six pigs (mean weight 30xa0kg). The posterior colpotomy and pneumoperitoneum was created by a standard double-channel flexible videoendoscope which was then used to perform peritoneoscopy. Concomitant gastroscopy allowed selection of a site along the greater curvature for lymphatic mapping by submucosal injection of methylene blue (3xa0ml). Furthermore, torque upon this endoscope allowed the posterior surface of the stomach and retrogastric space to become accessible to the transvaginal endoscope. In surveying the mapping in vivo, the intraperitoneal scope could follow blue-stained efferent lymphatic channels to their first-order draining nodes (i.e., sentinel nodes). Conventional instruments worked down the scope’s channels were then used to perform the excisional biopsy. At procedure end, the animals underwent immediate laparotomy to ensure the safety and adequacy of the procedure.ResultsEach procedure was technically successful. Colpotomy, pneumoperitoneum, and peritoneoscopy were promptly achieved (mean 8xa0min). Post injection, blue efferent lymphatic channels were immediately appreciable in every animal. Five animals had sentinel nodes in their retropyloric region while the last mapped cephalad towards the esophagogastric junction. Two animals had alternative drainage channels identifying additional sentinel nodes. All blue nodes were dissected cleanly by the intraperitoneal scope and retrieved intact per vaginam. Mean lymphadenectomy time was 19xa0min. At laparotomy, there was no hematoma, ongoing hemorrhage, or visceral injury in any pig. There were no residual, missed stained nodes or channels.ConclusionNOTES sentinel node biopsy for the stomach is technically accomplishable in this experimental model. This proof of concept should encourage serious consideration of its applicability to clinical practice.

Transoral endoscopic esophageal myotomy based on esophageal function testing in a survival porcine model

BACKGROUNDnThe most effective treatment of achalasia is Heller myotomy.nnnOBJECTIVEnTo explore a submucosal endoscopic myotomy technique tailored on esophageal physiology testing and to compare it with the open technique.nnnDESIGNnProspective acute and survival comparative study in pigs (n = 12; 35 kg).nnnSETTINGnUniversity animal research center.nnnINTERVENTIONnEight acute-4 open and 4 endoscopic-myotomies followed by 4 survival endoscopic procedures.nnnMAIN OUTCOME MEASUREMENTSnPreoperative and postoperative manometry; esophagogastric junction (EGJ) distensibility before and after selective division of muscular fibers at the EGJ and after the myotomy was prolonged to a standard length by using the EndoFLIP Functional Lumen Imaging Probe (Crospon, Galway, Ireland).nnnRESULTSnAll procedures were successful, with no intraoperative and postoperative complications. In the survival group, the animals recovered promptly from surgery. Postoperative manometry demonstrated a 50% drop in mean lower esophageal sphincter pressure (LESp) in the endoscopic group (mean preoperative LESp, 22.2 ± 3.3 mm Hg; mean postoperative LESp, 11.34 ± 2.7 mm Hg; P < .005) and a 69% loss in the open procedure group (mean preoperative LESp, 24.2 ± 3.2 mm Hg; mean postoperative LESp, 7.4 ± 4 mm Hg; P < .005). The EndoFLIP monitoring did not show any distensibility difference between the 2 techniques, with the main improvement occurring when the clasp circular fibers were taken.nnnLIMITATIONSnHealthy animal model; small sample.nnnCONCLUSIONnEndoscopic submucosal esophageal myotomy is feasible and safe. The lack of a significant difference in EGJ distensibility between the open and endoscopic procedure is very appealing. Were it to be perfected in a human population, this endoscopic approach could suggest a new strategy in the treatment of selected achalasia patients.

Improving functional esophageal surgery with a “smart” bougie: endoflip

BackgroundAn emerging imaging tool, the functional lumen imaging probe (Endoflip; Crospon Ltd, Galway, Ireland), provides a real-time measurement of esophagogastric junction (EGJ) capacity and diameter, which would be of particular interest in functional esophageal surgery such as Heller myotomy and antireflux procedures. This study aimed to demonstrate the intraoperative use of endoflip in the treatment of achalasia and gastroesophageal reflux disease (GERD).MethodsIn the first case, Heller myotomy was performed under endopflip guidance, for persistent dysphagia after failed endoscopic dilatation. In the second case, the endoflip was used to calibrate a Nissen fundoplication. With the patient under general anesthesia, the endoflip catheter was inserted orally and positioned to straddle the EGJ. At each stage of the procedure, the balloon was inflated by liquid filling at 40–30xa0ml/min. Live diameter data, cross-sectional area (CSA), and balloon pressure were displayed on the system at all times.ResultsBefore the myotomy, the pressure in the balloon rose to 15xa0mmxa0Hg at a CSA of 25xa0mm2, indicating that the EGJ is rigid and tight. After the myotomy, the pressure rose to 8xa0mmxa0Hg, and the CSA opened to 34xa0mm2, indicating that the EGJ was now very compliant and flaccid. After the Dor fundoplication, the junction became less compliant, but it could open at its narrowest point to 35xa0mm2 at a pressure of 20xa0mmxa0Hg, suggesting that the EGJ was tighter but not as rigid as before. The second part of the video demonstrates that the Endoflip acted as a “smart bougie,” evaluating the orientation and position of a properly constructed floppy Nissen.ConclusionsThe endoflip provides a system in which physiology and anatomy are represented dynamically in the same image. This “smart bougie” could be integrated into the surgical routine to improve outcome and to facilitate surgical training and the learning curve in esophageal functional surgery.

Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: An international multicenter study

BACKGROUND AND AIMSnPer-oral endoscopic myotomy (POEM) has shown promising safety and efficacy in short-term studies. However, long-term follow-up data are very limited. The aims of this study were to assess (1) clinical outcome of patients with a minimum post-POEM follow-up of 2 years and (2) factors associated with long-term clinical failure after POEM.nnnMETHODSnA retrospective chart review was performed that included all consecutive patients with achalasia who underwent POEM with a minimum follow-up of 2 years at 10 tertiary-care centers. Clinical response was defined by a decrease in Eckardt score to 3 or lower.nnnRESULTSnA total of 205 patients (45.8% men; mean age, 49 years) were followed for a median of 31 months (interquartile range, 26-38 months). Of these, 81 patients (39.5%) had received previous treatment for achalasia before POEM. Clinical success was achieved in 98% (185/189), 98% (142/144), and 91% (187/205) of patients with follow-up within 6 months, at 12 months, andxa0≥24 months, respectively. Of 185 patients with clinical response at 6 months, 11 (6%) experienced recurrent symptoms at 2 years. History of previous pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23). Procedure-related adverse events occurred in 8.2% of patients and only 1 patient required surgical intervention. Abnormal esophageal acid exposure and reflux esophagitis were documented in 37.5% and 18% of patients, respectively. However, these rates are simply a reference number among a very selective group of patients.nnnCONCLUSIONSnPOEM is safe and provides high initial clinical success and excellent long-term outcomes. Among patients with confirmed clinical response within 6 months, 6% had recurrent symptoms by 2 years.

Surgical access to the adrenal gland: the quest for a "no visible scar" approach.

Surgery of the adrenal glands has various approaches and remains technically challenging. Many different techniques have been used to decrease morbidity. The most important one is probably laparoscopy which has already quite dramatically improved clinical outcome. The second one is the introduction of posterior endoscopic approach (retroperitoneoscopy), which entirely preserves peritoneal integrity. This concept seems to us to be a fundamental in surgery of the retroperitoneum. Recently, new developments have emerged in the field of abdominal surgery. The most radical concept, known as Natural Orifice Transluminal Endoscopic Surgery (NOTES), consists of the introduction of both endoscope and working instruments through natural orifices in order to eliminate skin incisions and their associated morbidities. Although transperitoneal adrenalectomy has previously been reported in a porcine model, here we report our initial experiences of extra-peritoneal transvaginal NOTES approach of the retroperitoneum, focused on the field of adrenal surgery in both porcine and cadaver models. Whether clinical applications will ultimately be derived of this concept is still not clear certainly it raises new possibilities for interesting developments.

Efficacy and Safety of Peroral Endoscopic Myotomy for Treatment of Achalasia After Failed Heller Myotomy

BACKGROUND & AIMS: In patients with persistent symptoms after Heller myotomy (HM), treatment options include repeat HM, pneumatic dilation, or peroral endoscopic myotomy (POEM). We evaluated the efficacy and safety of POEM in patients with achalasia with prior HM vs without prior HM. METHODS: We conducted a retrospective cohort study of 180 patients with achalasia who underwent POEM at 13 tertiary centers worldwide, from December 2009 through September 2015. Patients were divided into 2 groups: those with prior HM (HM group, exposure; n = 90) and those without prior HM (non‐HM group; n = 90). Clinical response was defined by a decrease in Eckardt scores to 3 or less. Adverse events were graded according to criteria set by the American Society for Gastrointestinal Endoscopy. Technical success, clinical success, and rates of adverse events were compared between groups. Patients were followed up for a median of 8.5 months. RESULTS: POEM was technically successful in 98% of patients in the HM group and in 100% of patients in the non‐HM group (P = .49). A significantly lower proportion of patients in the HM group had a clinical response to POEM (81%) than in the non‐HM group (94%; P = .01). There were no significant differences in rates of adverse events between the groups (8% in the HM group vs 13% in the non‐HM group; P = .23). Symptomatic reflux and reflux esophagitis after POEM were comparable between groups. CONCLUSIONS: POEM is safe and effective for patients with achalasia who were not treated successfully by prior HM. Although the rate of clinical success in patients with prior HM is lower than in those without prior HM, the safety profile of POEM is comparable between groups.