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Intramural Endoscopic Dissection Using Pressurized Gas: A Novel Approach to Large Area Mucosal Resection and Polypectomy?
**184 Novel Procedure of Grasper-associated Endoscopic Mucosal Resection Against Early Gastric Cancer Hiroyuki Imaeda, Yasushi Iwao, Haruhiko Ogata, Hidekazu Suzuki, Naoki Hosoe, Tatsuhiro Masaoka, Manabu Nakashita, Tomoko Tsuda, Koichi Aiura, Hiroshi Nagata, Koichiro Kumai, Toshifumi Hibi, Hiromasa Ishii BACKGROUND and AIM: Endoscopic mucosal resection (EMR) by submucosal dissection against early gastric cancer has improved the rate of en blocresection, however more skillful technique should be necessary in comparison with strip biopsy technique, and it has been claimed that there are more complications. Recently many kinds of devices of instruments in EMR have been reported, however it is still difficult to dissect the submucosa of lesions especially located in gastric body. The aim of this study is to assess the usefulness of grasper-associated endoscopic mucosal resection which we have designed against early gastric cancer. SUBJECTS and METHODS: Subjects were 11 lesions of early gastric cancer which has been thought to be remained within the mucosa of gastric body. The average size of those lesions was 16.5mm (range 10-25mm). A short hood (4-mm in length) was attached to the distal tip of an endoscope, and a flexible overtube was inserted with the endoscope. After marking around lesions, 10% glycerin with indigocarmine and epinephrine was injected into the submucosa. After the circumferential mucosa around the lesion was cut by a needle knife, then the endoscope was pulled out once. Next, a grasper (inside grasper) was inserted through a working channel, and a distal portion of another grasper outside the endoscope (outside grasper) was grasped by inside grasper, thereafter the endoscope was inserted again with the outside grasper. After the lesion was grasped by the outside grasper under control of the inside grasper and the endoscope, the inside grasper was pulled out. Finally, while pulling up the lesion from anal towards oral side by the outside grasper, the submucosal dissection was performed from the anal side lesion. RESULTS: (1) Traction of those lesions towards the oral side by the outside grasper achieved more open and wide range of the vision of the submucosa. (2) All 11 lesions were able to be resected en block by this procedure. (3) Operating time was approximately 60 minutes and shorter than conventional procedure. (4) During procedure, small amount of hemorrhage was the only complication, and there happened no perforation. Furthermore, combined this procedure with squirting water, detection of bleeding spot and instant hemostasis was able to be performed. CONCLUSION: This novel procedure of grasper-associated EMR could make submucosal dissection certainly, more easier and safer against early gastric cancer located in gastric body.
**185 Intramural Endoscopic Dissection Using Pressurized Gas: A Novel Approach to Large Area Mucosal Resection and Polypectomy? Jose G. de la Mora, Elizabeth Rajan, Christopher J. Gostout, Lori Herman, Mary Knipschield, Jodie Deters BACKGROUND: Submucosal emphysema is a recognized complication of Argon Plasma Therapy. However this rapidly occurring submucosal bleb is rarely of clinical significance & is readily absorbed. AIM: We hypothesized that a controlled submucosal burst of a gas could separate the mucosa effectively as a first stage to intramural resection and thus to approach difficult flat polyps or large areas from the inside-out (submucosal space to mucosa). METHODS: Four 40 - 50 kg pigs were studied. CO2 under pressure was used. The device consists of a commercially available handle and disposable CO2 canisters (AR Technologies) slightly modified to fit a regular sclerotherapy needle (Olympus NM-200L-0423). Duration and flow can be regulated by the operator. Endoscopic procedures were done under general anesthesia. Multiple bursts of CO2 were applied starting in the small bowel, then in the stomach (antrum, body and fundus) & finally in the esophagus. 2 pigs were followed for a week, re-endoscoped & sacrificed. 2 were sacrificed acutely; in one of these, multiple methods were tried to lift the detached mucosa. Variables: lifting or not of the mucosa at each site, time of application, size (area) and duration of the formed bleb were studied. RESULTS: Bleb formation was immediate in all sites. Although we aimed to deliver different times at each site, in practice an area/time relation could not be established, due to progressive decrease in flow when the canisters were used. Duration of blebs was < 1min in the esophagus and duodenum. Gastric blebs lasted for (mean, range): 6:15 min (4:208:23). In the fundus, blebs formed rapidly and it was easy to obtain large blebs. Duration was always >20 min. Treated areas in the stomach ranged from 89mm2 to 330mm2. Macroscopic findings in the acutely sacrificed pigs were: intramural hematoma (1/10 sites in esophagus), subserosal bleb (2 sites in the same pig) and very small mucosal nodularity in all treated gastric sites. Clinical course of animals survived for 1 week was uneventful. Endoscopic and macroscopic examination of these animals at 1 week was normal. CONCLUSIONS: Based on our initial experience, a burst of CO2 appears to be effective for separating large areas of mucosa in the upper GI tract. Further studies are needed to define the possible role of this novel method.
VOLUME 59, NO. 5, 2004
**186 Testing of a New Device for Endoscopic Mucosal Resection for the Esophagus and Colon Paul Swain, Per-Ola Park, Maria Bergson, Annette Fritscher-Ravens, Keiichi Ikeda Background: Endoscopic mucosal resection of Barrett segments or other dysplastic abnormalites in the esophagus or colon is difficult to control precisely with injection and snare closure. A cylindrical end-cap on the tip of an endoscope limits the area of tissue that can be resected and takes circular disks of tissue from tubular structures. Large volume resections in esophagus and colon risk perforation. Aim: To test a device designed to resect large volumes of esophageal or colonic tissue in strips controlling the depth of resected tissue. Materials and methods: The resection device was formed using a flexible over-tube with an operating tip. The proximal end of the over-tube featured an airtight seal allowing passage of conventional endoscopes of 6-11mm, thumb control allowed the linear resection wire to be moved to cut a rectangular section of tissue at the tip, diathermy connector, adjustable needle injector and port for saline injection. At the distal end tissue could be sucked into a rectangular cavity of 1 3 3 cm. Depth of tissue cut was controlled by a soft plastic sling under the cavity. The needle could be advanced into tissue in the centre of the proximal edge of the cavity. Saline could be injected with precision at any predetermined point in the proximal margin of the area to be resected. The overtube had a soft open conical endpiece, which could be occluded by pushing it against tissue and applying suction. The endoscope could be pushed through the cone to examine the stomach or colon. Results: The device was used in postmortem esophagus and colon, and the esophagus of the anesthetized pig. Intubation over an endoscope or catheter was atraumatic. The device was used with 11 mm (2.8 mm channel) and 5.9 mm (2.2 mm channel) endoscopes. Suction was effective in filling the rectangular resection cavity. The raised semitransparent bleb after injection filled half the cavity. The separation of the mucosa from the muscle could be clearly viewed as the linear diathermy wire cut through the tissue in the rectangular cavity. The resected specimens were a neat rectangle of mucosa and submucosal exposing the deep muscle. The tissue was retained in the tube for removal. Optimal diathermy settings were 40-60 W pure cut. No bleeding was observed. Perforation did not occur. Conclusion: A new device for resection of Barrett segments or other mucosal or submucosal abnormalities was described. It was easy to use, removed mucosal and submucosal strips of predetermined depth and appeared safe in bench and live animal testing.
**187 Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms Rami Rami Eliakim, Inbal Shlomi, Alain Suissa, Kamal Yassin Background: Gastroesophageal Reflux Disease (GERD) is common. Erosive esophagitis, ulcers and Barrett’s Metaplasia (BM) characterize severe GERD. BM is a pre-cancerous condition which is found in up to 10% of GERD patients. Patients with BM have 0.5% risk per patient years of adenocarcinoma. Screening for BM has been shown cost-effective at the age of 50 years. However, lower screening costs and increased patient compliance are desired. The newly developed M2A Esophageal Capsule Endoscopy (ECE) (Given Imaging) offers an alternative approach to visualize the esophagus. Aim: To compare ECE to traditional flexible endoscopy in detection of esophageal pathologies. Methods: The Esophageal Capsule (11 3 30mm) acquires video images from both ends at 4fr/sec (2 fr/sec 3 2 imagers). The Capsule was ingested by 17 fasting patients with suspected esophageal disorders. The capsule was ingested in supine position (head flexed up). Subsequently, the patient was placed under conscious sedation and a traditional endoscopy was performed with a gastroscope. The investigator interpreting ECE was blinded to the traditional endoscopy results and vice versa. Results: 12 of 17 patients had positive esophageal findings using the gastroscope as the gold standard. ECE identified esophageal pathology in all 12 patients, and additional pathology in one patient that was missed by the gastroscope. For the purpose of this study, the additional finding was regarded as false positive. The Positive Predictive Value of ECE was 92% and the Negative Predictive Value was 100%. ECE sensitivity was 100% and specificity 80%, compared to traditional endoscopy. Mean esophageal passage time was 189 sec. There were neither swallowing problems nor side effects. Conclusions: ECE is a convenient, patientfriendly, sensitive method for visualization of esophageal disorders and may provide an effective method to screen patients for Barrett’s Esophagus. Further studies are needed to statistically confirm above results and to confirm that positive findings by ECE, which were missed by traditional endoscopy, are in fact true positives. A multi-center study is under way.
GASTROINTESTINAL ENDOSCOPY
P91
**185 Intramural Endoscopic Dissection Using Pressurized Gas: A Novel Approach to Large Area Mucosal Resection and Polypectomy? Jose G. de la Mora, Elizabeth Rajan, Christopher J. Gostout, Lori Herman, Mary Knipschield, Jodie Deters BACKGROUND: Submucosal emphysema is a recognized complication of Argon Plasma Therapy. However this rapidly occurring submucosal bleb is rarely of clinical significance & is readily absorbed. AIM: We hypothesized that a controlled submucosal burst of a gas could separate the mucosa effectively as a first stage to intramural resection and thus to approach difficult flat polyps or large areas from the inside-out (submucosal space to mucosa). METHODS: Four 40 - 50 kg pigs were studied. CO2 under pressure was used. The device consists of a commercially available handle and disposable CO2 canisters (AR Technologies) slightly modified to fit a regular sclerotherapy needle (Olympus NM-200L-0423). Duration and flow can be regulated by the operator. Endoscopic procedures were done under general anesthesia. Multiple bursts of CO2 were applied starting in the small bowel, then in the stomach (antrum, body and fundus) & finally in the esophagus. 2 pigs were followed for a week, re-endoscoped & sacrificed. 2 were sacrificed acutely; in one of these, multiple methods were tried to lift the detached mucosa. Variables: lifting or not of the mucosa at each site, time of application, size (area) and duration of the formed bleb were studied. RESULTS: Bleb formation was immediate in all sites. Although we aimed to deliver different times at each site, in practice an area/time relation could not be established, due to progressive decrease in flow when the canisters were used. Duration of blebs was < 1min in the esophagus and duodenum. Gastric blebs lasted for (mean, range): 6:15 min (4:208:23). In the fundus, blebs formed rapidly and it was easy to obtain large blebs. Duration was always >20 min. Treated areas in the stomach ranged from 89mm2 to 330mm2. Macroscopic findings in the acutely sacrificed pigs were: intramural hematoma (1/10 sites in esophagus), subserosal bleb (2 sites in the same pig) and very small mucosal nodularity in all treated gastric sites. Clinical course of animals survived for 1 week was uneventful. Endoscopic and macroscopic examination of these animals at 1 week was normal. CONCLUSIONS: Based on our initial experience, a burst of CO2 appears to be effective for separating large areas of mucosa in the upper GI tract. Further studies are needed to define the possible role of this novel method.
VOLUME 59, NO. 5, 2004
**186 Testing of a New Device for Endoscopic Mucosal Resection for the Esophagus and Colon Paul Swain, Per-Ola Park, Maria Bergson, Annette Fritscher-Ravens, Keiichi Ikeda Background: Endoscopic mucosal resection of Barrett segments or other dysplastic abnormalites in the esophagus or colon is difficult to control precisely with injection and snare closure. A cylindrical end-cap on the tip of an endoscope limits the area of tissue that can be resected and takes circular disks of tissue from tubular structures. Large volume resections in esophagus and colon risk perforation. Aim: To test a device designed to resect large volumes of esophageal or colonic tissue in strips controlling the depth of resected tissue. Materials and methods: The resection device was formed using a flexible over-tube with an operating tip. The proximal end of the over-tube featured an airtight seal allowing passage of conventional endoscopes of 6-11mm, thumb control allowed the linear resection wire to be moved to cut a rectangular section of tissue at the tip, diathermy connector, adjustable needle injector and port for saline injection. At the distal end tissue could be sucked into a rectangular cavity of 1 3 3 cm. Depth of tissue cut was controlled by a soft plastic sling under the cavity. The needle could be advanced into tissue in the centre of the proximal edge of the cavity. Saline could be injected with precision at any predetermined point in the proximal margin of the area to be resected. The overtube had a soft open conical endpiece, which could be occluded by pushing it against tissue and applying suction. The endoscope could be pushed through the cone to examine the stomach or colon. Results: The device was used in postmortem esophagus and colon, and the esophagus of the anesthetized pig. Intubation over an endoscope or catheter was atraumatic. The device was used with 11 mm (2.8 mm channel) and 5.9 mm (2.2 mm channel) endoscopes. Suction was effective in filling the rectangular resection cavity. The raised semitransparent bleb after injection filled half the cavity. The separation of the mucosa from the muscle could be clearly viewed as the linear diathermy wire cut through the tissue in the rectangular cavity. The resected specimens were a neat rectangle of mucosa and submucosal exposing the deep muscle. The tissue was retained in the tube for removal. Optimal diathermy settings were 40-60 W pure cut. No bleeding was observed. Perforation did not occur. Conclusion: A new device for resection of Barrett segments or other mucosal or submucosal abnormalities was described. It was easy to use, removed mucosal and submucosal strips of predetermined depth and appeared safe in bench and live animal testing.
**187 Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms Rami Rami Eliakim, Inbal Shlomi, Alain Suissa, Kamal Yassin Background: Gastroesophageal Reflux Disease (GERD) is common. Erosive esophagitis, ulcers and Barrett’s Metaplasia (BM) characterize severe GERD. BM is a pre-cancerous condition which is found in up to 10% of GERD patients. Patients with BM have 0.5% risk per patient years of adenocarcinoma. Screening for BM has been shown cost-effective at the age of 50 years. However, lower screening costs and increased patient compliance are desired. The newly developed M2A Esophageal Capsule Endoscopy (ECE) (Given Imaging) offers an alternative approach to visualize the esophagus. Aim: To compare ECE to traditional flexible endoscopy in detection of esophageal pathologies. Methods: The Esophageal Capsule (11 3 30mm) acquires video images from both ends at 4fr/sec (2 fr/sec 3 2 imagers). The Capsule was ingested by 17 fasting patients with suspected esophageal disorders. The capsule was ingested in supine position (head flexed up). Subsequently, the patient was placed under conscious sedation and a traditional endoscopy was performed with a gastroscope. The investigator interpreting ECE was blinded to the traditional endoscopy results and vice versa. Results: 12 of 17 patients had positive esophageal findings using the gastroscope as the gold standard. ECE identified esophageal pathology in all 12 patients, and additional pathology in one patient that was missed by the gastroscope. For the purpose of this study, the additional finding was regarded as false positive. The Positive Predictive Value of ECE was 92% and the Negative Predictive Value was 100%. ECE sensitivity was 100% and specificity 80%, compared to traditional endoscopy. Mean esophageal passage time was 189 sec. There were neither swallowing problems nor side effects. Conclusions: ECE is a convenient, patientfriendly, sensitive method for visualization of esophageal disorders and may provide an effective method to screen patients for Barrett’s Esophagus. Further studies are needed to statistically confirm above results and to confirm that positive findings by ECE, which were missed by traditional endoscopy, are in fact true positives. A multi-center study is under way.
GASTROINTESTINAL ENDOSCOPY
P91