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Background: Remote control of capsule endoscopes might allow reliable inspection of the human stomach., Objective: To assess the safety and efficacy of manipulation of a modified capsule endoscope with magnetic material (magnetic maneuverable capsule [MMC]) in the human stomach by using a handheld external magnet., Design: Open clinical trial., Setting: Academic hospital., Patients: Ten healthy volunteers., Interventions: Subjects swallowed the MMC and sherbet powder for gastric distention. An external magnetic paddle (EMP-2) was used to manipulate the MMC within the stomach. MMC responsiveness was evaluated on a screen showing the MMC film in real time., Main Outcome Measurements: Safety and tolerability (questionnaire), gastric residence time of the MMC, its responsiveness to the EMP-2, area of gastric mucosa visualized., Results: There were no adverse events. The MMC was always clearly attracted by the EMP-2 and responded to its movements. It remained in the stomach for 39 ± 24 minutes. In 7 subjects, both the cardia and the pylorus were inspected and 75% or more of the gastric mucosa was visualized (≥50% in all of the remaining subjects). A learning curve was clearly recognizable (identification of MMC localization, intended movements)., Limitations: Small amounts of fluid blocked the view of apical parts of the fundus; gastric distention was not sufficient to flatten all gastric folds., Conclusions: Remote control of the MMC in the stomach of healthy volunteers using a handheld magnet is safe and feasible. Responsiveness of the MMC was excellent, and visualization of the gastric mucosa was good, although not yet complete, in the majority of subjects. The system appeared to be clinically valuable and should be developed further. (, Clinical Trial Registration Number: DE/CA05/2009031008.)., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Remote control of esophageal capsule endoscopes could enhance diagnostic accuracy., Objective: To assess the safety and efficacy of remote magnetic manipulation of a modified capsule endoscope (magnetic maneuverable capsule [MMC]; Given Imaging Ltd, Yoqneam, Israel) in the esophagus of healthy humans., Design: Randomized, controlled trial., Setting: Academic hospital., Patients: This study involved 10 healthy volunteers., Intervention: All participants swallowed a conventional capsule (ESO2; Given Imaging) and a capsule endoscope with magnetic material, the MMC, which is activated by a thermal switch, in random order (1 week apart). An external magnetic paddle (EMP; Given Imaging) was used to manipulate the MMC within the esophageal lumen. MMC responsiveness was evaluated on a screen showing the MMC film in real time., Main Outcome Measurements: Safety and tolerability of the procedure (questionnaire), responsiveness of the MMC to the EMP, esophageal transit time, and visualization of the Z-line., Results: No adverse events occurred apart from mild retrosternal pressure (n = 5). The ability to rotate the MMC around its longitudinal axis and to tilt it by defined movements of the EMP was clearly demonstrated in 9 volunteers. Esophageal transit time was highly variable for both capsules (MMC, 111-1514 seconds; ESO2, 47-1474 seconds), but the MMC stayed longer in the esophagus in 8 participants (P < .01). Visualization of the Z-line was more efficient with the ESO2 (inspection of 73% ± 18% of the circumference vs 33% ± 27%, P = .01)., Limitations: Magnetic forces were not strong enough to hold the MMC against peristalsis when the capsule approached the gastroesophageal junction., Conclusion: Remote control of the MMC in the esophagus of healthy volunteers is safe and feasible, but higher magnetic forces may be needed., (Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Remote manipulation of wireless capsule endoscopes might improve diagnostic accuracy and facilitate therapy., Objective: To test a new capsule-manipulation system., Setting: University hospital., Design and Interventions: A first-in-human study tested a new magnetic maneuverable wireless capsule in a volunteer. A wireless capsule endoscope was modified to include neodymium-iron-boron magnets. The capsule's magnetic switch was replaced with a thermal one and turned on by placing it in hot water. One imager was removed from the PillCam colon-based capsule, and the available space was used to house the magnets. A handheld external magnet was used to manipulate this capsule in the esophagus and stomach. The capsule was initiated by placing it in a microg of hot water. The capsule was swallowed and observed in the esophagus and stomach by using a gastroscope. Capsule images were viewed on a real-time viewer., Main Outcome Measurements: The capsule was manipulated in the esophagus for 10 minutes. It was easy to make the capsule turn somersaults and to angulate at the cardioesophageal junction. In the stomach, it was easy to move the capsule back from the pylorus to the cardioesophageal junction and hold/spin the capsule at any position in the stomach. The capsule in the esophagus and stomach did not cause discomfort., Limitations: Magnetic force varies with the fourth power of distance., Conclusions: This study suggests that remote manipulation of a capsule in the esophagus and stomach of a human is feasible and might enhance diagnostic endoscopy as well as enable therapeutic wireless capsule endoscopy., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoscopic closure of inadvertent or intentional colon perforations might be valuable if comparable to surgical closure., Objective: The aim of this study was to compare endoscopic closure of a 4-cm colon perforation in a porcine model with surgical closure in a multicenter study., Setting: University hospitals in the United States and Europe., Design and Interventions: After creating a 4-cm linear colon perforation, the animals were randomized to either endoscopic or surgical closure. The total procedure time from the beginning of perforation to the completion of procedure was measured. The animals were euthanized after 2 weeks to evaluate healing, unless there was a complication., Results: Fifty-four animals were randomized to either surgical or endoscopic closure of colon perforation. Eight animals developed complications, and 7 of these were euthanized before 2 weeks. Twenty-three animals in each group survived for 2 weeks. Surgical closure of the perforation was successful in all animals in that group, and endoscopic closure was successful in 25 of the 27 animals. The median procedure time was shorter in the surgery group compared to the endoscopy group (35 vs 44 minutes, P = .016). Peritonitis, local adhesions, and leak test results were comparable in both groups. Distant adhesions were less frequent in the endoscopic closure group (26.1% vs 56.5%, P = .03). Five of the 186 T-tags (2.7%) were noted in the adjacent viscera., Limitation: This porcine study does not mimic clean colon perforation in humans; it mimics dirty colon perforation in humans., Conclusions: Endoscopic closure of a 4-cm colon perforation was comparable to surgery, and this technique can be potentially used for closure of intentional or inadvertent colon perforations.

Background: To perform advanced endoscopic treatments, one has to be able to close defects and perforations. Many devices have been constructed to perform endoscopic suturing, but all are rather complicated, expensive, and difficult to use., Objective: To develop and use a new simple stitching technique at intraluminal flexible endoscopy., Design: A flexible 19-gauge needle, loaded with a metal tag attached to a 3-0 polypropylene thread is passed down the working channel of a conventional endoscope. Two tags are placed into the stomach or the intestinal wall, 1 on each side of the defect. The threads are then locked together and cut. Precise stitch positioning is possible. Multiple stitches can be placed quickly, without removal of the endoscope., Setting: Surgical department at Sahlgrenska University Hospital in Göteborg, Sweden., Patients: Three patients in whom other conventional treatments had failed., Interventions: Initially, survival studies in pigs were performed, and full-thickness resections, pyloroplasty, and gastrojejunostomies could be completed. The technique was subsequently used in patients when surgery was not feasible and when other endoscopic interventions had failed., Main Outcome Measurements: Clinical evaluation; successful sealing of defects, leaks, or a bleeding vessel., Results: We present 3 human cases and describe endoluminal closure of a perforated duodenal ulcer, a leaking gastroenteroanastomosis after gastroplasty, and successful treatment of upper-GI bleeding by oversewing a bleeding vessel., Conclusions: This stitching technique is easy to use and makes endoscopic suturing possible for closure of perforations and tissue approximation almost anywhere in the GI tract that can be reached by a flexible endoscope.

Background: Pyloroplasty with myotomy and sutured closure is a surgical treatment for gastric outlet obstruction. It has not been previously performed at flexible endoscopy., Objective: To develop and test a method for performing a sutured pyloroplasty at flexible endoscopy., Design: A Heinicke-Miculicz pyloroplasty was performed, forming a linear myotomy through the pylorus from the gastric side into the duodenal bulb. This was subsequently sutured transversely to increase the opening. The operation was performed in 3 nonsurvival studies in pigs. The safety and the efficacy was then studied in 7 animals followed for up to 4 weeks after the procedure., Setting: The studies were performed in experimental surgical units in Gothenburg, Sweden, and London, UK., Interventions: A linear needle-knife incision was made through the pylorus; full-thickness sutures, by using a new T-tag and polypropylene thread suturing system through a flexible gastroscope, were placed to close the incision transversely. In 2 pigs, the prepyloric bulge was excised before the pyloroplasty., Results: Pyloroplasty was readily accomplished at flexible endoscopy in the 3 nonsurvival studies. Six of 7 pigs that survived in this study for periods of 7 to 28 days, recovered well, without complications. One pig (with bulge removal) developed gastric retention. The pyloric opening was increased; it was then easy to enter the duodenum at follow-up endoscopy., Limitations: This method has yet to be studied clinically., Conclusions: Pyloroplasty with full-thickness pyloromyotomy and transverse closure of a linear myotomy was accomplished by using a simple flexible endosurgical technique to test a new flexible suturing system.

Background: High intraabdominal pressures during laparoscopy (greater than 15 mm Hg) are dangerous. Pressures developed during translumenal endosurgery when using flexible endoscopes without feed-back regulation are unknown., Objective: To measure and control intraabdominal pressures during transgastric endosurgery., Design: In a blinded study, intraabdominal pressures during unregulated transgastric cholecystectomy and tubal ligation were measured by using Veress needles in 5 pigs (group 1). The accessory channel valve of a double-channel gastroscope was modified to allow measurement and control of intraabdominal pressures with a laparoscopic insufflator. This was tested prospectively in another blinded study in 5 pigs (group 2) that underwent identical procedures to those in group 1, with independent Veress needle pressure measurements., Setting: This ethically approved study was performed in an experimental surgical operating theater., Interventions: Transgastric cholecystectomy (n=4) and tubal resection (n=6)., Main Outcome Measures: Intraabdominal pressure measurements during transgastric endosurgery, with and without feed-back control., Results: The mean (standard deviation) number of pressure measurements per procedure greater than 20 mm Hg was 11+/-1.41 in group 1 and 0+/-0 in group 2 (P<.05). Most episodes of high pressure were undetected by the endoscopist, who was blinded to the pressure measurements., Conclusions: Unacceptably high intraabdominal pressures were common during translumenal endosurgical procedures. Feedback pressure regulation through a modified valve prevented overinflation.

Background: Guidewires and catheters exert less force on the gut wall than an endoscope., Objective: To develop a guidewire-assisted device for colonoscopy., Methods: A light-weight flexible catheter illuminated with light-emitting diodes was designed to carry an ultraslim high-resolution videoendoscope of 3 mm. Tip bend stiffness was 5 times less than a colonoscope. Hinged guidewires were passed, folded, through the accessory channel. A loop could be rapidly formed to explore the lumen., Results: The catheter followed curves of excised pig colon and exerted significantly less force on the colon wall than a colonoscope (mean 1.6 +/- 0.23 N vs 3.0 +/- 0.37 N, P < .05; bend-radius, 80 mm). Survival studies in pigs showed that the guidewire loop could be advanced under visual control and the Cath-Cam could be advanced by using much less force than the colonoscope., Conclusions: A catheter-based colonoscope with a miniature video imager reduced the force required for successful colonoscopy in pigs.

Background: Transgastric flexible endoscopic anastomosis might offer advantages over open and laparoscopic surgery, especially for bariatrics or patients with obstructive malignancy., Objective: To develop methods for performing transgastric anastomosis., Design/results: Twelve gastrojejunal anastomoses were formed in pigs weighing 27 kg to 38 kg (6 each in survival and nonsurvival groups) by using a per-oral double-channel gastroscope. The stomach was penetrated with a needle-knife guidewire combination and bow-sphincterotome incision. The small intestine (SI) was grasped with a snare-over-forceps method and pulled into the stomach for suturing. Sutures were placed in pairs through the deep muscle of the stomach and small intestine to join the tissues securely. The SI was incised with a needle-knife to open the anastomosis. Anastomoses were placed close to the cardioesophageal junction for bariatric purposes or in the antrum for pancreatic bypass. Survival studies in 6 pigs showed anastomosis patency at 7 to 10 days., Conclusion: Gastrojejunal anastomosis was accomplished via the transgastric route by using a new double-channel endoscopic method.

Background: EUS-guided fine needle aspiration (EUS-FNA) is a reliable tool for tissue diagnosis of unexplained mediastinal or perigastric lymphadenopathy but may be ineffective in sampling a small malignant focus in it or removing an entire node., Objective: To develop a new EUS-guided endoscopic-transgastric method to approach (sentinel) lymph nodes, including node marking and lymphadenectomy., Design: Experimental study., Setting: Animal experiments at an approved university college., Subjects: Six pigs had a linear-array EUS examination 1 week after a transgastric procedure. All had reactive perigastric lymph nodes., Interventions: Selected nodes were punctured with a 19-gauge EUS needle. A metal anchor with thread, loaded onto the needle, was placed across the lymph nodes to pull the node toward the stomach. After gastric-wall dissection with a needle knife at the point of emergence of the thread, the nodes were removed by pulling on the thread and the anchor. The gastric incision was closed with an endoscopic suturing system., Main Outcome and Measurements: Proof of the feasibility to endoscopically remove paragastric lymph nodes by an EUS-guided transgastric approach., Results: In all pigs, lymph-node marking with an anchor and thread was possible. Traction exerted on these nodes showed that they could be pulled against the gastric wall for subsequent removal. In 2 of 6 examinations, the entire sequence of the procedure, node tagging, gastric-wall incision, lymphadenectomy, and wall closure was performed. No serious complication occurred., Limitations: Animal study throughout, small numbers, no humans to date., Conclusions: Transgastric lymphadenectomy with EUS for node selection and capturing seems feasible.

Background: Poor colon cleaning frequently impairs colonoscopy. The aim of the study was to develop a method of cleaning the colon during colonoscopy., Methods: A soft-tipped catheter with a water jet spray at its tip was designed to break up and propel stool contents in the direction of the anus. Stool contents were collected in a container attached to an endoscopy trolley., Observations: In bench tests, colon models filled with porridge were rapidly cleaned. Unprepared colons (n = 15) of anesthetized pigs were cleared in a few minutes by using this device at colonoscopy, by advancing the catheter under direct vision into concretions, which were rapidly broken down. There was minimal trauma to mucosa in these survival studies., Conclusions: A colon cleaning method for use at colonoscopy was highly effective in cleaning colon models and in unprepared pig colon. This device may have a role in cleaning the colon in unprepared or poorly prepared patients.

Background: Transgastric flexible endoscopic surgery might offer advantages over open and laparoscopic surgery. The aim of this study was to develop methods for performing transgastric biliary endosurgery., Methods: Cholecystectomies and biliary anastomoses were performed in 8 anesthetized pigs (27-30 kg) in nonsurvival studies. Two endoscopes passed perorally were inserted through the stomach wall after needle-knife incision. Endoscope-induced pneumoperitoneum allowed viewing and manipulation of the gallbladder with both endoscopes independently. The cystic duct was dissected, clipped, and transected. Cholecystectomy was performed with one of two methods: either by using two endoscopes, or a single endoscope and a 5-mm-diameter grasping instrument inserted transabdominally. Clips and sutures were used to attach the gallbladder to the stomach wall, and an incision was made to form a cholecystogastrostomy. In survival experiments in 8 pigs, transgastric incisions were closed with endoscopic sutures., Results: The gallbladder was successfully removed in 8 pigs (nonsurvival experiments). The time for the procedure ranged from 2.5 hours to 40 minutes and decreased with experience. At postmortem examination, clips placed on the cystic duct and the artery were secure. An anastomosis was successfully formed between gallbladder and stomach in 3 pigs. In 8 pigs, full-thickness incisions in the stomach wall were closed with two to 4 stitches. All 8 pigs survived (median follow-up, 22 days; range 14-28 days)., Conclusions: Transgastric gallbladder surgery, including cholecystectomy and biliary anastomosis, is feasible. Full-thickness gastric incisions were safely closed in survival studies. The efficacy and the safety of transgastric surgery merits further study.

Background: Endoluminal operations for gastroesophageal reflux currently are limited by the inability to visualize and manipulate structures outside the wall of the gut. This may be possible by using EUS. The aims of this study were the following: to define the EUS anatomy of structures outside the gut that influence reflux, to place stitches in the median arcuate ligament, to perform posterior gastropexy, and to test the feasibility of crural repair under EUS control in pigs., Methods: In survival experiments in 22 pigs, by using a linear-array echoendoscope, the median arcuate ligament and part of the right crus were identified and punctured with a needle, which served as a carrier for a tag and thread. These were anchored into the muscle. An endoscopic sewing device was used, allowing stitches to be placed through a 2.8-mm accessory channel to any predetermined depth. New methods allowed knot tying and thread cutting through the 2.8-mm channel of the echoendoscope., Results: Stitches were placed through the gastric wall into the median arcuate ligament, and one stitch was placed just beyond the wall of the lower esophageal sphincter. The stitches were tied together and locked against the gastric wall. Median lower esophageal sphincter pressure, determined manometrically, was 11 mm Hg before surgery and 21 mm Hg after stitch placement (p=0.0002). The length of the lower esophageal sphincter increased from a median of 2.8 cm before the procedure to 3.5 cm after the procedure. At the postmortem, the median force required to pull the tags out of the median arcuate ligament was 2.8 kg., Conclusions: This study demonstrates that transgastric gastroesophageal reflux surgery, by using stitching under EUS control, can significantly increase lower esophageal sphincter pressure in pigs.

Background: The ability to place sutures under EUS control might allow development of a new type of transluminal endosurgery. The aim of this study was to develop endoscopic methods for suturing to variable predetermined depths in the wall of the GI tract and to allow fixation of adjacent hollow organs under EUS control., Methods: A suturing device was constructed for suturing under EUS control to any desired depth. Sutures can also be placed into hollow or solid organs within 5 cm of the endoscope tip. The device allows multiple sutures to be placed without withdrawing the endoscope. Stitching, knot-tying, and thread-cutting are achieved through a 2.8-mm accessory channel., Results: Multiple (>100) sutures were placed in predetermined gut wall layers in pigs. Sutures were placed in the gallbladder (n = 7) and small intestine (n = 8) to fix the gallbladder/small intestine to the stomach and allow traction for the insertion of stents and other devices through the 2 lumens., Conclusion: A new method for stitching under flexible EUS control is described. This technology was used to place sutures at precise depths in the GI tract. It allowed fixation of other organs to the accessible GI tract for various purposes including delivery of stents and devices for creating anastomoses.

Background: A video capsule has been developed to acquire photographic images of the small intestine during normal peristaltic motion., Methods: Patients between 21 and 80 years of age referred for enteroscopy because of obscure GI bleeding were offered entry into a trial in which they would undergo both capsule endoscopy and subsequent push enteroscopy. Results of capsule examinations were compared with push enteroscopy findings. Capsule endoscopy was performed with the Given M2A video capsule system., Results: Twenty-one patients (12 women, 9 men, average age 61 years) were enrolled, all of whom completed the study. A bleeding site was found in 11 of 20 patients during capsule endoscopy. No additional intestinal diagnoses were made by enteroscopy. The yield of push enteroscopy in the evaluation of obscure bleeding was 30% (6/20), the yield of capsule endoscopy 55% (11/20). This difference did not reach statistical significance (p = 0.0625). Capsule endoscopy found a distal source of bleeding in 5 of 14 patients who had normal push enteroscopic examinations. Patients preferred capsule endoscopy to enteroscopy., Conclusions: This pilot study demonstrates that capsule endoscopy provides excellent visualization of the small intestine, is well tolerated by patients, and is safe. Capsule endoscopy identified small intestinal bleeding sites beyond the range of push enteroscopy.