Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expanding metal stents in benign upper gastrointestinal conditions: a comparative multicenter international study (With Video).

BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper gastrointestinal (GI) conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Stentfix {SF], Ovesco Endoscopy) for stent anchoring has recently been developed. The aim of this study was to evaluate the effect of OTSC fixation on FCSEMS migration rate. METHODS: In this retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions from January 2011 to October 2022 at 16 centers, the primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events. RESULTS: A total of 311 (no fixation [NF] 122, SF 94, endoscopic suturing [ES] 95) patients underwent 316 stenting procedures. Compared with the NF group (n = 49, 39%), the rates of stent migration were significantly lower in the SF (n = 16, 17%, P = .001) and ES (n = 23, 24%, P = .01) groups. The rates of stent migration were not different between the SF and ES groups (P = .2). On multivariate analysis, SF (odds ratio [OR], 0.34, 95% CI, 0.17-0.70, P < .01) and ES (OR, 0.46, 95% CI, 0.23-0.91; P = .02) were independently associated with decreased risk of stent migration. Compared with the NF group (n = 64; 52%), there were higher rates of clinical success in the SF (n = 64; 68%; P = .03) and ES (n = 66; 69%; P = .02) groups. There was no significant difference in the rates of adverse events among the 3 groups. CONCLUSION: Stent fixation using OTSCs is safe and effective at preventing stent migration and may also result in improved clinical response.

Clinical feasibility of a new full-thickness endoscopic plication device (GERDx™) for patients with GERD: results of a prospective trial.

BACKGROUND: Previous studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL). METHODS: Prospective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II-III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.) RESULTS: There were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication. CONCLUSIONS: Endoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.

Endoscopic Transmural Therapy of Pancreatic Fistulas in an Interdisciplinary Setting-A Retrospective Data Analysis.

Pancreatic fistulas belong to the most feared complications after surgery on or near the pancreas, abdominal trauma, or severe pancreatitis. The majority occur in the setting of operative interventions and are called postoperative pancreatic fistulas (POPF). They can lead to various complications, including abscesses, delayed gastric emptying or hemorrhages with a significant impact on morbidity and mortality. Several risk factors have been identified, including smoking, high BMI, male gender, and age. Prophylactic measures and treatment options have been explored but with limited success. This study aimed to analyze the incidence and management of pancreatic fistulas treated in a tertiary referral center, particularly focusing on an endoscopic approach. The data of 60 patients with clinically relevant pancreatic fistulas were analyzed between 2018 and 2021. Different treatment approaches, including conservative management, percutaneous drainage, transpapillary stenting, and endoscopic transmural drainage, were evaluated. An endoscopic transmural approach using lumen-apposing metal stents (LAMS) was used in almost half of this cohort showing promising results, with a high rate of fistula closure in refractory cases and a mean time until closure of 2.7 months. The findings suggest that an endoscopic approach, particularly using LAMS, can be effective in the management of pancreatic fistulas.

Endoscopic Submucosal Dissection in the Upper Gastrointestinal Tract and the Need for Rescue Surgery-A Multicenter Analysis.

Endoscopic submucosal dissection (ESD) has become the standard treatment for early malignant lesions in the upper gastrointestinal (GI) tract. Its clinical results have been reported to be as good as surgery. The outcomes of rescue surgery after non-curative ESD have been reported to be as good as first-line surgery. The aim of this study was to evaluate the outcomes of ESD in the upper GI tract and the outcomes of rescue surgery after non-curative ESD performed in Linz, Austria, between 2009 and January 2023. A total of 193 ESDs were included and divided into 104 esophageal ESD and 89 gastric ESD procedures. The criteria for curative ESD were in line with established guidelines' recommendations. For esophageal lesions, the mean lesion size was 40.3 mm and the rate of curative ESD was 56.7%. In the non-curative ESD, the rate of technical failure as the reason for non-curative ESD was 13.3% and the oncological failure rate was 86.7%. Only 48.7% of indicated rescue surgeries were performed. The main reason for not performing surgery was interdisciplinary consensus due to comorbidity. Perioperative complications Dindo-Clavien ≥ 3 occurred in 22.2% of cases with an in-hospital mortality rate of 0. In gastric lesions, the mean size was 39 mm and the rate of curative ESD was 69.7%. The rate of technical failure as a reason for non-curative ESD was 25.9% and the oncological failure rate was 74.1% for non-curative ESD. Rescue surgery was performed in 48.2% of indicated cases. The perioperative rate for major complications was 0. The outcome of ESD in the upper GI tract is in line with the published literature, and non-curative ESD does not worsen surgical outcomes. The available follow-up data are in line with the international published literature, showing a low rate of residual malignancy in surgical resection specimens. Therefore, the indication of rescue surgery for oncological failure remains challenging. Furthermore, the learning curve of ESD has shown a trend towards improving outcomes over time.

Optimizing surgical approach for natural orifice translumenal endoscopic procedures.

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) often requires some degree of retroflexion of the endoscopic operating system. This study investigates the impact of retroflexion on task performance in NOTES. METHODS: In a bench-top simulation, surgeons were required to manipulate a single-channel endoscope to touch 4 dots in a predetermined order. The task was performed under the forward-view and retroflexed-view conditions. RESULTS: Tasks performed under the forward-view condition were significantly faster than those performed under the retroflexed-view condition (P = .005). Also, 5 experienced surgeons completed tasks in less time than the novices (P = .043). Experienced surgeons were mildly affected by the inverted image, whereas the novices were vulnerable to image malalignment. CONCLUSION: Careful selection of the surgical approach to avoid image malalignment is suggested for safe performance of NOTES. Extensive training is required for novices to overcome the vision-motion difficulty before they can perform NOTES safely and effectively.

Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy.

OBJECTIVE: To compare short-term surgical outcomes and quality of life (QOL) between single-port laparoscopic cholecystectomy (SPLC) and classic 4-port laparoscopic cholecystectomy (CLC). BACKGROUND: There is significant interest in further reducing the trauma associated with surgical procedures. Although a number of observational studies have suggested that SPLC is a feasible alternative to CLC, there is a lack of data from randomized studies validating any benefit over CLC. METHODS: Eligible patients were randomized to receive SPLC or CLC. Operative and perioperative outcomes, including cosmesis and QOL were analyzed. RESULTS: Forty-three patients were randomized to SPLC (n = 21) or CLC (n = 22). There were no significant differences between groups for most preoperative demographics, American Society of Anesthesiology score, gallstone characteristics, local inflammation, blood loss, or length of stay. Patients undergoing SPLC were older than those receiving CLC (57.3 years vs. 45.8 years, P < 0.05). Operative times for SPLC were greater than CLC (88.5 minutes vs. 44.8 minutes, P < 0.05). Overall and cosmetic satisfaction, QOL as determined by the SF-36 survey, postoperative complications, and post-operative pain scores between discharge and 2-week postoperative visit were not significantly different between groups. Wound infection rates were similar in both groups. The SPLC group contained 1 retained bile duct stone, 1-port site hernia, and 1 postoperative port site hemorrhage. CONCLUSIONS: SPLC procedure time was longer and incurred more complications than CLC without significant benefits in patient satisfaction, postoperative pain and QOL. SPLC may be offered in carefully selected patients. Larger randomized trials performed later in the learning curve with SPLC may identify more subtle advantages of one method over another.

A natural orifice transrectal approach for oncologic resection of the rectosigmoid: an experimental study and comparison with conventional laparoscopy.

BACKGROUND: A transrectal (TR) approach for natural orifice translumenal endoscopic surgery (NOTES) makes sense for colorectal surgery because the colotomy can be incorporated into subsequent anastomosis. Because cancer is a primary indication for left-sided colon resection, oncologic standards will have to be met by a NOTES procedure. This study aimed to assess whether pure TR rectosigmoidectomy can be performed with strict adherence to oncologic principles compared with a conventional laparoscopically assisted approach (LAP). METHODS: Human male cadavers were allocated to either TR (n = 4) or LAP (n = 2). A simulated sigmoid lesion was created at 25 cm. Transrectal retrograde mobilization of the rectosigmoid was performed using conventional transanal endoscopic microsurgery (TEM) instrumentation. After ligation of the superior hemorrhoidal artery and further mobilization, the specimen was delivered transanally and divided extracorporeally. Using a circular stapler, NOTES colorectal anastomosis was performed. Lymph node yield, adequate resection margins, and operative time were compared with LAP. RESULTS: Transrectal retrograde rectosigmoid dissection was achieved in all attempts (4/4) and showed numbers of lymph nodes (median, 5; range, 3-6) similar to the LAP group (median, 4.5; range, 2-7). One pure TR approach failed to resect the lesion. Three TR procedures required additional mobilization via an abdominal approach to provide adequate margins. The mean length of TR specimens was 16 ± 4 cm compared with 31 ± 9 cm achieved by LAP (p < 0.01). The TR operative time was significantly longer (247 ± 15 vs 110 ± 14 min). CONCLUSION: Lymph node yield during TR rectosigmoidectomy was similar to that achieved by the LAP approach. However, conventional TEM instrumentation alone did not permit adequate colon mobilization. This indicates a need for flexible instrumentation or other technical solutions to perform true NOTES colectomies.

Efficacy of using a novel endoscopic lens cleaning device: a prospective randomized controlled trial.

INTRODUCTION: Clear visualization of the surgical field is critical in laparoscopic surgery. The authors evaluated a device that does not necessitate an external cleaning process for the laparoscope. It was hypothesized that it will minimize the interruption in operative workflow. METHODS: A total of 40 advanced laparoscopy patients were randomized to either the control or device group. Demographic data, procedural data, length of stay, frequency and duration of lens cleaning, and lens clarity scores (LCS) were recorded. Independent samples t test and Fisher's exact test were performed. RESULTS: No significant difference was found between the device and control groups in demographic data, procedure time (P = .922) or LCS (P = .124). Laparoscope cleaning in the device group was significantly shorter than in the control group (P < .001). No complications were observed. CONCLUSION: An intra-abdominal laparoscopic cleaning device can effectively clean the laparoscopic lens and lead to less workflow interruption. Although not documented in this study, it may also lead to shorter operative times.

Endoscopic closure of gastrogastric fistulas by using a tissue apposition system (with videos).

BACKGROUND: Gastrogastric fistulas (GGFs) are seen in 1.5% to 12.5% of patients after Roux-en-Y gastric bypass (RYGB) bariatric surgery, often leading to failure to lose adequate weight. OBJECTIVE: The aim of this study was to assess the feasibility, safety, and percentage of successful primary endoluminal closures of GGFs by using a recently developed tissue apposition system in combination with local mucosectomy. DESIGN: A feasibility and outcome study following institutional review board protocol. SETTING: Tertiary referral teaching hospital, Legacy Health System, Portland, Oregon. INTERVENTIONS: A combination of mucosectomy and nonresorbable tissue apposition is used to achieve a permanent closure of the GGF. PATIENTS: Four patients with 5 GGFs after RYGB; the mean fistula diameter of was 18.6 mm (range 10-30 mm). RESULTS: Primary closure rate (1 endoscopic session) of 5 GGFs was 100%. The mean procedure time was 88.5 minutes. One to 4 pairs of tissue anchors were used to close the fistulas. The mean time for performing mucosectomy was 21.6 minutes (range 8-42 minutes) and 39.6 minutes (range 12-58 minutes) for fistula closure. Estimated blood loss was on average 2 mL (range 0-5 mL). No complications were recorded. Early success (3 months), as evidenced by early satiety and weight loss, was noted for 3 of 4 patients. After 3 months, only the smallest fistula (10 mm) was still completely closed, and after 6 months, it also showed a pinhole opening. CONCLUSION: It was feasible to close all fistulas endoscopically without complications. Permanent closure of GGFs could not be achieved.

A comparison of early learning curves for complex bimanual coordination with open, laparoscopic, and flexible endoscopic instrumentation.

BACKGROUND: This study takes an initial step towards understanding the learning process of flexible endoscopic surgery. Bimanual coordination learning curves were contrasted between three different surgical paradigms. We hypothesized that use of an open or laparoscopic paradigm would result in better performance and a shorter learning process (reaching a learning plateau earlier) than an endoscopic paradigm. METHODS: Our model required seven subjects to perform identical bimanual coordination tasks with three different tools (a dual-channel endoscope with graspers, laparoscopic Maryland graspers, and straight hemostats for open surgery). The task required subjects to coordinate two instruments in order to perform a series of standardized maneuvers. Performance was measured by movement speed and accuracy. The learning process was broken down into three distinct phases: the practice phase, the short-term retention phase, and the long-term retention phase. The learning curves of four surgical novices for 33 tasks with each device were compared with the performance of three surgeons. RESULTS: Overall performance speed was significantly faster using open or laparoscopic tools than endoscopy for all groups (open 13 ± 1 s; lap 28 ± 3 s; endo 202 ± 82 s; P < 0.001). The difference between open and laparoscopy was not significant (P = 0.149). There was no significant difference (P = 0.434) in accuracy (number of ring drops) between any of the devices. Novices performed significantly slower than the expert in the endoscopy task (P = 0.010). Their performance improved with practice (P = 0.005) but they failed to reach the level of the expert after the practice phase (novices: 202.3 ± 23.4 s versus expert: 89.0 ± 34 s, P = 0.009). CONCLUSIONS: Bimanual coordination tasks have shortest performance time and are easiest to learn using an open surgery paradigm. Performance times and the learning process take longer for the laparoscopic paradigm and significantly longer for the endoscopic paradigm.

Measuring mental workload during the performance of advanced laparoscopic tasks.

INTRODUCTION: Mental workload is a finite resource and is increased while learning new tasks and performing complex tasks. Measurement of a surgeon's mental workload may therefore be an indication of expertise. We hypothesized that surgeons who were expert at laparoscopic suturing would have more spare mental resources to perform a secondary task, compared with surgeons who had just started to learn suturing. METHODS: Standardized suturing tasks were performed on a bench-top model. Twelve junior residents (novices) and nine fellows and attending surgeons (experts) were instructed to perform as many sutures as possible in 6 min. An adjacent monitor was placed 15 degrees off axis to the first and randomly displayed 30 true visual signals among 90 false ones. Participants were required to identify the true signals while continuing to suture. Laparoscopic sutures were evaluated using the Fundamentals of Laparoscopic Surgery (FLS) scoring system. The secondary (visual detection) task was evaluated by calculating the rate of missed true signals or detection of false signals. RESULTS: Experts completed significantly more secure sutures (6 +/- 2) than novices (3 +/- 1; p = 0.001). The suture performance score was 50 +/- 20 for experts, significantly higher than for novices (29 +/- 10; p = 0.005). The rate for detecting visual signals was higher for experts (98%) compared with for novices (93%; p = 0.041). CONCLUSION: Practice develops automaticity, which reduces the mental workload and allows surgeons to have sufficient spare mental resources to attend to a secondary task. Visual detection provides a simple and reliable way to assess mental workload and situation awareness abilities of surgeons during skills training, and may be an indirect measure of expertise.

Use of flexible endoscopes for NOTES: sterilization or high-level disinfection?

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) involves the use of flexible endoscopes to perform intra-abdominal or intra-thoracic surgeries. Surgery in the operating room usually involves sterile instrumentation, whereas in the endoscopy suite high-level disinfection seems to be sufficient. Our objective was to assess the necessity for endoscope sterilization for clinical NOTES and to develop an endoscope processing protocol based on a score for the available processing options. METHODS: Score and processing protocol development for clinical NOTES endoscopes was based on a comprehensive review of the available relevant literature. Options for sterilization for flexible endoscopes in the Good Samaritan Hospital, Legacy Health in Portland, Oregon, were analyzed for patient safety, potential for recontamination, cost, and validation. RESULTS: Literature survey indicated that there is controversy surrounding the necessity for sterilization of surgical endoscopes. However, standard of practice seems to call for sterile instrumentation for surgery and it is possible to terminally sterilize flexible endoscopes. Within our institution, a score was created to rank the available sterilization options. We successfully introduced a protocol for sterilization of endoscopes for use in clinical NOTES procedures. The protocol involved mechanical cleaning and high-level disinfection per Multi-Society Guidelines, with subsequent terminal sterilization using a validated peracetic acid protocol. CONCLUSIONS: It remains controversial whether sterile instrumentation is truly needed for surgery. It is difficult but possible to terminally sterilize flexible endoscopes. We recommend sterile instrumentation for clinical NOTES until well-designed, randomized, clinical trials are available and guidelines are published.

Bimanual coordination in natural orifice transluminal endoscopic surgery: comparing the conventional dual-channel endoscope, the R-Scope, and a novel direct-drive system.

BACKGROUND: The devices used for natural orifice transluminal endoscopic surgery procedures are endoscopes or inspired by endoscopic design, which makes it difficult to accomplish bimanual coordination. OBJECTIVE: We evaluated 3 operating systems in simulated natural orifice transluminal endoscopic surgery procedures requiring complex bimanual coordination. DESIGN: Operators were required to perform an identical bimanual task by using 3 operating systems: a dual-channel endoscope (DCE); the R-Scope, which has 2 elevators for independent movement of endoscopic instruments; and the Direct Drive Endoscopic System (DDES), which allows separation of instruments and vision, emulating more of a laparoscopic surgery paradigm. SETTING: A bench-top simulation was used. Twelve teams were recruited for DCE and R-Scope testing. Twelve individuals participated in the DDES setup. The task included 3 steps: picking up a ring, passing it between endoscopic instruments, and placing it on a designated location. MAIN OUTCOME MEASUREMENTS: Task performance was evaluated by movement speed and accuracy. RESULTS: Task performance was significantly faster when using the DDES system (29 +/- 28 seconds) compared with the other operating systems (DCE: 140 +/- 55 seconds, R-Scope: 160 +/- 71 seconds; P < .001). The difference between the DCE and the R-Scope was not significant (P = .370). CONCLUSION: Designs that separate vision and motion have more degrees of freedom at the tip of the instruments, and an ergonomic user interface provides benefits for bimanual performance compared with more traditional endoscopic designs. With the DDES, a single operator can perform complex endoscopic tasks faster than 2 operators with a DCE or R-Scope.

A multitasking platform for natural orifice translumenal endoscopic surgery (NOTES): a benchtop comparison of a new device for flexible endoscopic surgery and a standard dual-channel endoscope.

BACKGROUND: A unique endoscopic platform with two independent end-effectors, each with five degrees of freedom, and an ergonomic user interface has been developed to address the needs of complex endolumenal and natural orifice translumenal endoscopic surgery (NOTES) procedures. This study aimed to measure the amount this new platform would improve performance for bimanual coordination compared with a standard dual-channel scope using a benchtop simulation. METHODS: Task 1 involved 12 individuals performing an identical bimanual coordination task with two different devices: a dual-channel endoscope (DCE) and the EndoSAMURAI prototype. The participants were separated into three groups with different levels of endoscopy and NOTES experience. A complex bimanual coordination task (pin transfer) was used. For this task, 12 pins had to be manipulated in a predetermined order. Performance was measured by movement speed, and accuracy. Comparisons were made between the two devices and the three groups of subjects. Task 2 required the same 12 participants to perform a standardized intracorporeal suture in a NOTES simulation. RESULTS: In the pin transfer task, overall performance speed was significantly faster using the EndoSAMURAI (304 ± 125 s) rather than the DCE (867 ± 312 s; P < 0.001). The difference between the two operating systems was more pronounced in the student group than in the surgeon group: experts (226 ± 41 vs. 620 ± 277 s), surgeons (333 ± 152 vs. 930 ± 283 s), students (318 ± 83 vs. 1021 ± 423 s). Accuracy, as indicated by the number of pin drops, also was significantly better using the EndoSAMURAI (0.4) rather than the DCE (1.8 drops; P = 0.006). In addition, all 12 participants were able to complete a suture using the EndoSAMURAI, but none could complete a suture using the DCE. CONCLUSIONS: The EndoSAMURAI enhances performance times and accuracy in complex surgical tasks compared with the conventional therapeutic endoscope.

Evolution of Transluminal Necrosectomy for Acute Pancreatitis to Stent in Stent Therapy: Step-Up Approach Leads to Low Mortality and Morbidity Rates in 302 Consecutive Cases of Acute Pancreatitis.

Background: The step-up approach, using either flexible endoscopy or a minimal invasive retroperitoneal access, has reduced mortality and morbidity in patients with acute pancreatitis. The use of fully covered self-expanding metal stents (FCSEMS) or lumen apposing metal stents (LAMS) facilitates endoscopic necrosectomy and drainage of walled-off necrosis (WON). The aim of our analysis was to investigate the 30/90/365-day mortality and morbidity rates of the subtypes of the revised Atlanta classification for acute pancreatitis. Materials and Methods: We conducted a retrospective analysis of all patients (n = 302) treated with acute pancreatitis in our institution from January 2014 to July 2017. Mortality, morbidity, management of fluid collections, interventions, complications, and new onset of diabetes were recorded. Results: In 30.8% (n = 93/302) of patients, pancreatic fluid collection developed. Out of these, 58.1% (54/93) required intervention, consisting of endoscopic treatment in 63% (34/54) or multidisciplinary approach in 37% (20/54). Overall, 90-day mortality rate according to Kaplan-Meier Estimator was 3.7%. Overall, 1-year mortality rate was 6.2%. One-year mortality for uncomplicated acute pancreatic fluid collection, pseudocyst, and WON were 5.4%, 2.6%, and 13.5%, respectively. Hemorrhage in case of metal stent treatment (FCSEMS/LAMS) occurred in 14.3%. If LAMS was combined with double pigtail stent-in-stent, bleeding was seen in 5.3%. No transperitoneal necrosectomy was needed. Conclusions: Treating acute pancreatitis with a step-up approach, including stent-in-stent procedures, leads to low mortality rates and few stent-associated bleeding complications and minimizes necessity for open transperitoneal surgical necrosectomy.

Interim Report of a Prospective Trial on the Clinical Efficiency of a New Full-thickness Endoscopic Plication Device for Patients With GERD: Impact of Changed Suture Material.

BACKGROUND: The aim of the present trial is to investigate the clinical efficiency of the GERDx device for patients with gastroesophageal reflux disease (GERD). MATERIALS AND METHODS: Prospective study evaluating Gastrointestinal Quality of Life Index, symptoms scores, as well as esophageal manometry and impedance-pH-monitoring data at baseline and 3 months after endoscopic full-thickness plication with the GERDx device. RESULTS: In total, 28 patients underwent the procedure so far. Mean Gastrointestinal Quality of Life Index scores, DeMeester scores, and general and reflux-specific scores improved (P<0.01). Three of 6 patients, who were treated with converted sutures, experienced postoperative complications. CONCLUSIONS: Endoscopic plication using the GERDx device may be effective in improving quality of life and GERD symptoms. Suture length between pledgets and suture material may have an impact on procedure outcomes.

Future applications of flexible endoscopy in esophageal surgery.

INTRODUCTION: Flexible endoscopy has long played a role in esophageal surgery, and procedures like perforation closure, stenting of occluding malignancies, antireflux procedures, and removal of Barretts are increasingly replacing open and laparoscopic procedures. We present early results of a series of acute animal experiments studying the feasibility of using flexible endoscopes for complex esophageal surgery such as Heller myotomy and esophagectomy. METHODS: A total of six animals and one human cadaver have been operated on in a series of three protocols. The first study involves extraluminal flexible endoscopy through a cervical incision. The esophagus is dissected to the phrenoesophageal junction and a Heller myotomy performed. The second study involves labeling specific mediastinal node areas using EUS and transesophageal tattooing. Transcervical access is once again obtained, and wide esophageal dissection is performed; sequential identification of the marked nodes is performed. The final study involves full thoracic esophageal mobilization and laparoscopic gastric mobilization for an esophagogastrectomy. RESULTS: Heller myotomy in five animals was performed via flexible endoscopy. Total operative time was 49 min with mean time for myotomy being 22 min. One animal had hemodynamic compromise from over insufflating the mediastinum with air. The second study involved three animals and one human cadaver. An average of four nodes was marked by EUS, and there was 100% success in identifying all nodes with flexible medistinoscopy. Operative times had a mean of 187 min (147-227) for the animal model and 198 min for the cadaver model. CONCLUSION: There is a move to increase the role of flexible endoscopy in GI surgery. This is facilitated by the introduction of novel scopes and instrumentation designed for NOTES. We outline early favorable results from animal studies looking at the use of flexible endoscopy as a surgical tool for Heller myotomy and esophagectomy.

Transcervical heller myotomy using flexible endoscopy.

INTRODUCTION: Esophageal achalasia is most commonly treated by laparoscopic myotomy. Transesophageal approaches using flexible endoscopy have recently been described. We hypothesized that using techniques and flexible instruments from our NOTES experience through a small cervical incision would be a safer and less traumatic route for esophageal myotomy. The purpose of this study was to evaluate the feasibility, safety, and success rate of using flexible endoscopes to perform anterior or posterior Heller myotomy via a transcervical approach. METHODS: This animal (porcine) and human cadaver study was conducted at the Legacy Research and Technology Center. Mediastinal operations on ten live, anesthetized pigs and two human cadavers were performed using standard flexible endoscopes through a small incision at the supra-sternal notch. The esophagus was dissected to the phreno-esophageal junction using balloon dilatation in the peri-esophageal space followed by either anterior or posterior distal esophageal myotomy. Success rate was recorded of esophageal dissection to the diaphragm and proximal stomach, anterior and posterior myotomy, perforation, and complication rates. RESULTS: Dissection of the esophagus to the diaphragm and performing esophageal myotomy was achieved in 100% of attempts. Posterior Heller myotomy was always extendable onto the gastric wall, while anterior gastric extension of the myotomy was found to be more difficult (4/4 and 2/8, respectively; P = 0.061). CONCLUSION: Heller myotomy through a small cervical incision using flexible endoscopes is feasible. A complete Heller myotomy was performed with a higher success rate posteriorly possibly due to less anatomic interference.