One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity.

INTRODUCTION: Here, we report the first series of patients with 1-year implantation of a novel, endoluminal, endoscopically delivered and retrieved gastro-duodeno-jejunal bypass sleeve (GJBS) (ValenTx, Inc. Carpinteria, CA, USA). In this report, we present the safety, feasibility of the device, weight loss, and changes in comorbidities. METHODS AND PROCEDURES: A prospective, single-center, 12-month trial was designed. The patients are morbidly obese individuals who meet the NIH criteria for bariatric surgery. The GJBS is a 120-cm sleeve secured at the esophago-gastric junction with endoscopic and laparoscopic techniques that is designed to create an endoluminal gastro-duodeno-jejunal bypass. The device was implanted and, at the completion of the trial, retrieved with an endoscopic technique. The primary endpoints were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss (EWL) and changes in comorbidities, specifically glucose control, use of antihyperglycemics, and changes in hemoglobin A1C levels. RESULTS: From July 2009 until October 2009, 13 patients were prospectively enrolled for the 1-year trial. The study included five men and eight women with a mean preoperative BMI of 42 kg/m(2). One patient was excluded, at the time of endoscopic evaluation, due to inflammation at the GE junction. Two additional patients required early explantation of the device, within the first 4 weeks, due to patient intolerance. Upon explant of the device, both patients' symptoms improved. In the remaining ten patients, the device was implanted, left in situ for 12 months, and then retrieved endoscopically. Safe delivery of the cuff at the gastro-esophageal junction was seen in all ten patients whom had device implants, without complication. No esophageal leak was seen immediately post-procedure or during follow-up. The sleeve device was well tolerated within the bowel lumen during the 12-month study, specifically, no bowel erosions, ulceration, or pancreatitis was observed. All ten patients reached the 1-year mark. Of the ten, six had fully attached and functional devices throughout the follow-up, verified by endoscopy. The mean percentage EWL, at 1 year, in this group was 54 %. In the remaining four patients, partial cuff detachment was observed at follow-up endoscopy. The percentage EWL was lower in this group. Of the six patients that reached a year with a fully attached device, five were followed at an average of 14-months post-explant (26 months from the time of device implant). These five maintained an average percentage EWL of 30 % at the 14-month post-explant follow-up. Co-morbidites measured included diabetes mellitus, hypertension, hyperlipidemia, and use of antihyperglycemics. Each of the measured comorbidities showed improvement during the 12-month trial. DISCUSSION: The endoluminal, GJBS can be safely placed and retrieved. The short-term data show it is well tolerated with a good safety profile. It achieves excellent weight loss results with over 70 % of all comorbidities resolved or significantly improved.

A randomized comparison of laparoscopic, flexible endoscopic, and wired and wireless magnetic cameras on ex vivo and in vivo NOTES surgical performance.

BACKGROUND: The influence of endoscopic video camera (VC) image quality on surgical performance has not been studied. Flexible endoscopes are used as substitutes for laparoscopes in natural orifice translumenal endoscopic surgery (NOTES), but their optics are originally designed for intralumenal use. Manipulable wired or wireless independent VCs might offer advantages for NOTES but are still under development. OBJECTIVE: To measure the optical characteristics of 4 VC systems and to compare their impact on the performance of surgical suturing tasks. METHODS: VC systems included a laparoscope (Storz 10 mm), a flexible endoscope (Olympus GIF 160), and 2 prototype deployable cameras (magnetic anchoring and guidance system [MAGS] Camera and PillCam). In a randomized fashion, the 4 systems were evaluated regarding standardized optical characteristics and surgical manipulations of previously validated ex vivo (fundamentals of laparoscopic surgery model) and in vivo (live porcine Nissen model) tasks; objective metrics (time and errors/precision) and combined surgeon (n = 2) performance were recorded. RESULTS: Subtle differences were detected for color tests, and field of view was variable (65°-115°). Suitable resolution was detected up to 10 cm for the laparoscope and MAGS camera but only at closer distances for the endoscope and PillCam. Compared with the laparoscope, surgical suturing performances were modestly lower for the MAGS camera and significantly lower for the endoscope (ex vivo) and PillCam (ex vivo and in vivo). CONCLUSIONS: This study documented distinct differences in VC systems that may be used for NOTES in terms of both optical characteristics and surgical performance. Additional work is warranted to optimize cameras for NOTES. Deployable systems may be especially well suited for this purpose.

New methods for innovation: the development of a toolbox for natural orifice translumenal endoscopic surgery (NOTES) procedures.

BACKGROUND: Devices used for flexible intralumenal procedures are inadequate when used for intraperitoneal surgical procedures such as cholecystectomy. OBJECTIVE: To assess/address limitations of flexible endoscopic devices in intraperitoneal surgery. DESIGN: To describe processes used to invent new devices to facilitate this new surgical genre. SETTING: Engineering laboratory. PATIENTS: None. INTERVENTIONS AND INVENTIONS: Reviews of the limitations of flexible endoscopic instruments and instrumentation/invention needs for a "NOTES cholecystectomy" were completed. MAIN OUTCOME MEASURES: The appropriateness of existing methods of device innovation was evaluated against an inventory of new technologies necessary to perform NOTES. The deficiencies in traditional innovation methods led to the creation of a novel process for invention of new medical devices: the "Inventorama." METHODS: Cooperation between clinicians and industry to develop device concepts to enable NOTES. RESULTS: The devices included: (1) steerable flex trocar, (2) rotary access needle, (3) bipolar hemostasis forceps, (4) Maryland dissectors, (5) articulating hook knife, (6) rotating hook knife, (7) articulating graspers, (8) scissors, (9) ligating clip applier, and (10) tissue apposition system. Six of these ten were built and tested as initial crude prototypes in the Inventorama process; two underwent major modifications. Three were invented via alternate methods, including by independent clinicians. CONCLUSIONS: A new method for efficient medical device invention and development was created to address key technology needs for NOTES. The result was a "toolbox" of devices designed to address the key surgical activities necessary for advanced intralumenal and translumenal flexible endoscopic procedures.

Human experience with an endoluminal, endoscopic, gastrojejunal bypass sleeve.

BACKGROUND: This report describes the authors' experience with a unique endoluminal, endoscopically delivered and retrieved gastroduodenojejunal bypass sleeve, including short-term weight loss and changes in comorbidities. METHODS: A prospective, single-center trial was designed. The patients were morbidly obese individuals who met the National Institutes of Health criteria for bariatric surgery. The device used was a unique gastroduodenojejunal bypass sleeve secured at the esophagogastric junction with endoscopic and laparoscopic techniques and designed to create an endoluminal gastroduodenojejunal bypass. At completion of the trial, the device was explanted with endoscopic retrieval. The primary end points were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in comorbidities, specifically glucose control, use of antihyperglycemic medications, and changes in hemoglobin A1c levels. RESULTS: From July 2008 to February 2010, 24 patients were enrolled in the trial. The gastroduodenojejunal bypass sleeve was implanted, left in situ, and then retrieved. The 7 men and 17 women in the study had a mean preoperative body mass index of 42 kg/m(2). The device was successfully delivered in 22 of the 24 patients (92%) and retrieved endoscopically from all 22 patients in whom it was implanted (100%). Two patients were excluded from the study preprocedurally. The one patient was excluded preoperatively due to noncompliance with the preoperative liquid diet. For the other excluded patient, the device was not attempted endoscopically due to significant inflammation at the gastroesophageal junction at the time of laparoscopic evaluation. Of the 22 patients who had the device implanted, 17 maintained it (77%) and completed the full 12-week trial. These patients had 39.7% excess weight loss at completion of the study. The primary reason for early explantation of the device was early postoperative dysphagia. The seven patients with preoperative diabetes mellitus all had normal blood glucose levels throughout the trial, and none required antihyperglycemic medications. All four patients with elevated hemoglobin A1c levels preoperatively showed improvement by the end of the trial. CONCLUSIONS: This trial demonstrated that the endoluminal gastroduodenojejunal sleeve can achieve excellent weight loss at 12 weeks. No patient safety issues were encountered. Adverse effects were minimal and resolved at endoscopic device removal. Effective glycemic control was demonstrated through use of the device during the trial. Long-term results are needed.

A randomized comparison of a new flexible bipolar hemostasis forceps designed principally for NOTES versus a conventional surgical laparoscopic bipolar forceps for intra-abdominal vessel sealing in a porcine model.

BACKGROUND: Current devices for hemostasis in flexible endoscopy are inferior to methods used during open or laparoscopic surgery and might be ineffective for natural orifice transluminal endoscopic surgery. OBJECTIVE: To compare new flexible bipolar forceps (FBF), designed principally for natural orifice transluminal endoscopic surgery, with laparoscopic bipolar forceps (LBF) for hemostasis of intra-abdominal porcine arteries. SETTING: Surgical laboratories in Europe and the United States. DESIGN AND INTERVENTIONS: New FBF for hemostasis (3.7-mm diameter), featuring electrode isolation, were compared with rigid 5-mm LBF (ERBE BiClamp LAP forceps) at recommended settings. A porcine model of acute hemostasis was prepared by suturing the uterine horns and cecum to the abdominal wall, exposing uterine arteries, ovarian pedicles, cecal mesenteric bundles, and the inferior mesenteric artery. This allowed access to 10 vessels in each pig by transabdominal laparoscopic devices or a transgastric double-channel gastroscope. Vessels were measured, coagulated at 4 and more points, and transected. Blood pressure was increased to more than 200 mm Hg for 10 minutes by administering phenylephrine. Delayed bleeding was identified. MAIN OUTCOME MEASUREMENTS: In 7 pigs, a total of 65 vessels (1.5-6.0 mm) were randomly allocated to FBF (n = 32) or LBF (n = 33). Successful hemostasis both before and after blood pressure increase was equivalent between the 2 groups (before: 88% FBF vs 88% LBF, not significant [NS]; after: 97% FBF vs 94% LBF, NS). With FBF, the number of seals per vessel was 4.8 vs 4.4 with LBF (NS). The energy used to create FBF seals was 19.8 J vs 38.2 J for LBF (P < .05). LIMITATIONS: Results from porcine studies may not reflect patient outcomes. CONCLUSIONS: In a porcine model, transgastric FBF endoscopic hemostasis was as effective as conventional laparoscopic hemostasis using LBF across a wide range of vessels.

Medium-term outcome of endoluminal gastroplication with the EndoCinch device in children.

OBJECTIVE: Endoluminal gastroplication (EG) is emerging as a minimally invasive procedure for the treatment of gastroesophageal reflux disease (GERD). The aim of this study is to evaluate the medium-term outcomes after EG in a pediatric patient population. PATIENTS AND METHODS: Seventeen children with a median age of 12.4 years (range 6.1-15.9 years) with GERD underwent EG using a flexible endoscopic sewing device (EndoCinch) over a period of 3 years. Three plications were placed in the gastric tissue below the lower esophageal sphincter. Drug dose requirement, pH measurements, symptom severity and frequency, and validated Quality of Life in Reflux and Dyspepsia (QOLRAD) scores were compared before EG and 1 and 3 years after EG. Statistical analysis was performed using a Wilcoxon rank-sum test and P < 0.05 was the threshold for significance. RESULTS: All patients showed an immediate posttreatment improvement in symptom severity, symptom frequency, and quality of life scores. Completed 1- and 3-year data were obtained from 16 patients. Four cases (25%) required a repeat procedure as a result of recurrence of symptoms after 2 to 24 months. Fourteen patients (88%) at 1 year and 9 patients (56%) at 3 years remained without a need for any antireflux medication. A sustained improvement in heartburn (P = 0.004), regurgitation (P = 0.017), and vomiting (P = 0.018) was seen at 3 years. The total QOLRAD score (maximum of 175) improved from a median of 87 (range 69-142) to 156 (range 111-175) at 1 year (P < 0.0001) and 153.5 (range 55-174) at 3 years (P = 0.002). CONCLUSIONS: EG is an effective and safe procedure in children. It is a viable option for the treatment of GERD refractory to or dependent on antireflux medications.

Endoscopic full-thickness resection: circumferential cutting method.

BACKGROUND: Endoscopic full-thickness resection (EFTR) at flexible endoscopy might allow less-invasive removal of more deeply penetrating cancers that have not spread to the serosal surface and more complete histologic examination of the excised tissue. OBJECTIVE: A method for closure of full-thickness defects in the stomach wall would be valuable for other endosurgical applications. SETTING: A method that uses an end cap and band-ligation without prior injection of saline solution to perform EFTR gave good results and was safe in pig studies. There is a size limitation of cancers that can be resected en bloc when using this method. The depth of resection was also variable. DESIGN AND INTERVENTIONS: EFTR was achieved by circumferential cutting with a sphincterotome and a snare. A prototype bidirectional cutter was tested. Sutured closure was accomplished by using a sheathed needle, a metal tag, and a thread at the tip, passed through a 2.8-mm accessory channel. Knot-tying devices secured the sutured defect. MAIN OUTCOME MEASUREMENTS: EFTR was studied in non-survival (n = 4) and survival (n = 8) experiments in pigs. RESULTS: Full-thickness specimens were resected from the gastric wall (100%, 12/12), and the defects were closed by using sewing and knot-tying devices (100%, 12/12). LIMITATIONS: A healing ulcer at the suturing site was evident at follow-up endoscopy in the survival experiments. Bleeding, which was stopped by suturing, occurred in 1 pig (8.3%, 1/12). All pigs survived these experiments without complications (100%, 8/8). CONCLUSIONS: Circumferential EFTR was feasible and appeared safe in survival experiments. This method might allow larger and deeper resection of tumors in the gastric wall.

Endoscopic full-thickness resection with sutured closure in a porcine model.

BACKGROUND: Some early gastric cancers might be advantageously staged and treated by full-thickness resection if secure methods for closing the defect were available. The aim of this study was to test the feasibility of full-thickness gastric resection. METHODS: Full-thickness gastric resections were performed by using a ligating device without submucosal injection in survival studies in pigs (n = 8). The defects were closed by using new methods for suturing, locking, and cutting thread through a 2.8-mm accessory channel. Stitches (n = 2-4) were placed close to the target area before resection. OBSERVATIONS: Full-thickness resections (n = 8) were performed. The pigs survived without incident for 21 to 28 days. Healing of the suture site was evident at follow-up endoscopy. Suture sites were water tight. The pull-out force with stitches by using this new sewing method was significantly higher than with endoscopic clips (20.3 N +/- 0.94 vs. 2.2 N +/- 0.42, p < 0.05). CONCLUSIONS: Endoscopic full-thickness resection with sutured defect closure was feasible and appeared safe in these survival experiments.

Transluminal endosurgery: single lumen access anastomotic device for flexible endoscopy.

BACKGROUND: Forming anastomoses between two hollow organs at flexible endoscopy might reduce the need for surgery for obstructing malignancy. Current methods require access to both lumens. The aim of this work was to develop methods of forming an anastomosis at flexible endoscopy, such as a gastrojejunostomy or cholecystoduodenostomy, when access to only one lumen is feasible. METHODS: A modified needle was passed through a large-channel echoendoscope from the accessible lumen into the target hollow organ. An anastomotic device was formed by using two 7F catheter segments, which were pushed over a guidewire into the target, the less accessible lumen. When released, by withdrawing the guidewire, the catheters formed a cross shape and created an anastomosis when compressed against a plate from the accessible side. OBSERVATIONS: These devices were tested in live animal experiments. With an echoendoscope in the stomach, it was repeatedly possible to place needles, threaded tags, and guidewires into the small intestine and gallbladder. In 4 to 7 days, anastomoses were formed in 16 pigs between the small intestine and the stomach, and between the gallbladder and the stomach. The initial diameter of the anastomoses ranged from 3 to 9 mm. No complication occurred. CONCLUSIONS: It is feasible to form anastomoses at flexible endoscopy when access is limited to a single side.

The wireless capsule: new light in the darkness.

The development of wireless capsule endoscopy offers the potential to examine the whole small intestine, with its 5-meter length, and has the advantage of being painless. Using a miniature CMOS camera and a short focal length lens, images are obtained, as the optical window of the capsule sweeps past the gut wall, without requiring air inflation of the gut lumen. The capsule endoscope is propelled by peristalsis through the gastrointestinal tract. The video images are transmitted using radiotelemetry to an array of aerials attached to the body which allows image capture. The images are stored on a small portable recorder carried on a belt and subsequently downloaded for analysis. The system allows more than 7 h of continuous recording of images of the gastrointestinal tract. The patients are free to continue their daily routine during the examination. The capsule endoscope has performed well in trials in patients with difficult gastrointestinal bleeding and in comparative studies with push enteroscopy. It has received both a CE mark and FDA approval for use in patients. It has been used to date in about 4,000 patients. The current clinical data are reviewed.