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1080j: Full-Thickness Gastric Biopsy: A Novel Percutaneous Endoscopic Transenteric (PEATE) Approach in Humans With Gastroparesis
Abstracts 1080h High Diagnostic Yield of Direct Endoscopic Mucosal Oxygen Saturation Measurements in Patients Suspected for Chronic Upper Gastrointestinal Ischemia Leon M. Moons, Aria Sana, De´sire´e Van Noord, Hence J. Verhagen, P. M. Pattynama, Ernst J. Kuipers, Peter Mensink Introduction: Chronic upper gastrointestinal ischemia (CUGI) is recognized as a fairly common condition with a wide clinical spectrum. Recent studies have shown that evaluation of mucosal ischemia is one of the main stays of correctly diagnosing CUGI. We showed that measuring mucosal oxygen saturation with visible light spectroscopy (VLS), easily applied to the mucosa through an endoscope, was equal to 24-hour tonometry for detecting mucosal ischemia. We investigated whether VLS, could be used as a pre-test in patients suspect of having CUGI. Methods: Patients referred to our center for evaluation of CUGI, had a standard work-up, consisting of evaluation of symptoms, CT-or MRangiography of the gastrointestinal arteries, and VLS. VLS measurements were performed during upper endoscopy in the duodenum, duodenal bulb, gastric antrum, corpus, and esophagus using saturation cut-off values as previously validated by direct comparison with tonometry. Results of VLS and angiography were discussed multidisciplinary and a consensus diagnosis was made: 1) normal arteries, no ischemia, 2) stenotic arterial vessel(s) without ischemia, 3) normal arteries with ischemia (non-occlusive), and 4) stenotic arterial vessel(s) with ischemia (occlusive). The latter 2 groups were advised to undergo treatment: either vasodilating medication, endovascular or surgical. The definite diagnosis CUGI was only made after persistent clinical response at ⱖ 6 months, after adequate therapy. Results: In a 2-year period, 152 patients were included: 102 female, age 59 (20 - 85) yrs. A definite diagnosis of CUGI was made in 84 pts: 66 with occlusive CUGI and 18 pts with non-occlusive CUGI. The clinical success rate of therapy was 96% for occlusive disease (endovascular or surgical) and 59% for non-occlusive disease (medical therapy). 77/89 (87%) pts with mucosal ischemia (VLS⫹) had CUGI, against 7/63 (11%) of pts without mucosal ischemia (VLS-)(sensitivity of VLS 92%, and specificity 82%; p⬍0.001). 65 (73%) of the VLS⫹ pts had a significant stenosis on CT-angiography against 10/63 (16%) of the VLS- pts (p⬍0.001). VLS was false-negative in 7 pts: 4 pts with occlusive CUGI (reevaluation due to worsening symptoms) and 3 with non-occlusive CUGI (identified by 24-hour tonometry). VLS appeared false-positive in 12 pts: 3 with occlusive and 9 with non-occlusive disease.Conclusion: Direct endoscopic measurement of mucosal oxygen saturation (VLS) allows adequate discrimination between CUGI and no ischemia. This makes VLS an important new tool in this area with a previous lack of functional tests. VLS may be used as an alternative screening test for CUGI in pts with a high clinical suspicion.
1080i Wireless Biosensing of Upper Gastrointestinal Bleeding: A Paradigm Shift in Diagnosis and Treatment Marvin K. Ryou, Alex Nemiroski, Dan E. Azagury, Sohail N. Shaikh, Michele B. Ryan, Keith L. Obstein, Robert M. Westervelt, Christopher C. Thompson Introduction: Upper GI bleeding (UGIB) accounts for approximately 300,000 hospitalizations per year in the U.S. Rebleed rates following UGIB can be as high as 20%, even after endoscopic intervention, and can lead to higher morbidity and mortality. We have developed an endoscopically implantable wireless biosensor which detects acute GI hemorrhage and specifically re-bleeding. The sensor emits a wireless emergency signal to medical personnel using Bluetooth technology. Aims: To develop and test an endoscopically implantable wireless biosensor for detection of UGIB in ex vivo and in vivo porcine models. Methods: Both ex vivo and acute porcine bleeding experiments were performed. Ex vivo experiments evaluated (1) the biosensor’s sensitivity for detecting fresh porcine blood as a function of blood concentration of a fluorphore and pH content of gastric milieu; and (2) the biosensors’s ability to wirelessly transmit a signal through soft tissue while also submerged. Subsequently, laparotomies were performed on 5 Yorkshire pigs to create acute UGIB models by transmural fixation of the gastroepiploic artery across the anterior gastric wall. An FDAapproved fluorophore was then intravenously injected and biosensors were endoscopically placed in the stomach or duodenum using endoscopic clips. The surgically fixed artery was then lacerated. Estimated blood loss leading to sensor activation was recorded. Results: Benchtop results showed maximal sensitivity of the sensor at a fluorophore concentration of 0.05 mg/mL, maximal sensitivity at pH 2.0, and a 10:1 signal-to-noise ratio despite the presence of food and food dyes. A porcine UGIB model was successfully created. Biosensors functioned successfully in 5/5 cases. Average estimated blood loss leading to biosensor activation was 30 cc (10cc - 75 cc), and the sensor could distinguish between old and new blood. Biosensors were able to wirelessly transmit out of the body without incident and successfully sent an emergency text message to the intended cell phone in all cases. Conclusions: This endoscopically implantable wireless biosensor successfully detected acute hemorrhage in a porcine UGIB model. It was able to detect a small volume of fresh blood and subsequently transmit a wireless emergency signal to a cell phone. Endoscopic placement of a biosensor for GI bleeding surveillance could potentially limit morbidity,
AB144 GASTROINTESTINAL ENDOSCOPY
Volume 71, No. 5 : 2010
mortality, and health-care costs associated with post hemorrhage supportive care and rebleeding. Furthermore, it may allow adjustment of the management algorithm to lower acuity levels for various clinical scenarios.
1080j Full-Thickness Gastric Biopsy: A Novel Percutaneous Endoscopic Transenteric (PEATE) Approach in Humans With Gastroparesis Christopher N. Andrews, Hughie F. Fraser, Emil Neshev, Paul Mintchev, Martin Storr, Oliver F. Bathe, Stefan J. Urbanski Background and Aim: Recent evidence suggests disruption of the enteric nervous system (ENS) in full-thickness stomach specimens from patients with gastroparesis (GP). Currently, obtaining gastric ENS tissue is invasive, requiring a laparoscopy or laparotomy. We recently reported a novel, simple and reliable method to obtain full-thickness gastric biopsies during endoscopy using a dog model (GIE, in press) and have now translated this approach into humans.Methods: Five patients (4 female, mean age 49 y, range 38-65) with clinically diagnosed GP (2 diabetic, 3 idiopathic) fasted overnight and were given a single dose of cefazolin 2g IV prior to upper endoscopy (EGD) with conscious sedation. A suitable biopsy area was chosen based on indentation of the anterior stomach wall by external finger pressure on the abdominal skin and by transillumination with the endoscope. Using sterile technique, skin and biopsy tract were anesthetized with lidocaine 2% using a 22 gauge (G) tracking needle and entry into the stomach was endoscopically confirmed. A 4 mm incision was then made through the abdominal skin and a spring-loaded biopsy gun with a 14 G coaxial needle (15 cm long, 20mm throw length, 1.6mm internal diameter) was used to take 4 separate distal corpus biopsies from each patient. Patients were monitored for 4 hours prior to discharge. Histological elements were compared to archived normal gastric tissue from 13 control gastrectomies. Results: The procedure was well tolerated by all patients. The procedure was aborted in one patient (BMI 37) where transillumination failed and the stomach could not be reliably accessed with the tracking needle. The first patient biopsied had an endoclip placed due to mild post-biopsy oozing. Post-procedure hemoglobin levels were unchanged. No further intervention was required postbiopsy in the other 3 patients. There was no suggestion of peritonitis, bleeding, or significant discomfort in any of the patients at 4 days and 30 days postoperatively. Biopsies identified circular & longitudinal muscle, neurons, and Interstitial Cells of Cajal (ICC) with standard stains. Average biopsy size was approx. 1.5 by 5 mm, with 8 or more high-power fields (400x) assessable on each biopsy. Two idiopathic GP patients had reduced ICC counts compared to controls.Conclusions: This study confirms the feasibility and preliminary safety of the novel PEATE biopsy technique in human patients. This minimally-invasive and simple method may allow for routine assessment of gastric ENS tissues in patients with suspected motility disorders. Funded in part by CLS R&D grant RE7133.
1080k Narrow Band Imaging vs. White Light Gastroscopy in Detecting Gastric Premalignant and Early Malignant Lesions: A Randomized Prospective Crossover Study Ashok Chacko, Amit Dutta, Kattiparambil G. Sajith Introduction: Narrow band imaging (NBI) detects mucosal surface details (pit pattern) as well as the microvasculature details of mucosa. In premalignant and early malignant conditions the pattern and regularity of pits and microvasculature are altered. Patients above 45 years of age with dyspeptic symptoms have higher risk of gastric malignancy than younger patients.Aims & Methods: We aimed to assess whether narrow band imaging is superior to conventional white light gastroscopy (WLG) in detecting gastric premalignant and early malignant lesions in patients above 45 years with dyspepsia. We conducted a randomized prospective crossover study from January 2009 to July 2009 at CMC, Vellore in India. Patients above 45 years of age with dyspepsia (ROME III criteria) in absence of alarm symptoms underwent gastric mucosal examination using WLG and NBI in same session by different endoscopists who were blinded to each others finding. Biopsy was taken if needed at the end of second scopy after a third observer reviewed report of both scopists. The sequence of scopies (WLG or NBI first) was determined by block randomization. The total yield of gastric premalignant lesions (atrophic gastritis, intestinal metaplasia, dysplasia, adenomatous polyp) and early malignancy was estimated for both. Comparison of sensitivities of the two screening tests was done using McNemar’s test. Kappa test was done to assess agreement between the two tests. The study was approved by institute review board and ethics committee. Results: A total of 200 (Males-132) patients participated in the study after giving written informed consent. The mean age was 52.3⫹6.4 years. The total number of patients diagnosed to have premalignant lesions by any of the two modalities were 32. No patient had early gastric cancer. WLG detected lesions in 17 patients (atrophic gastritis in 12, intestinal metaplasia in7,) and NBI in 31 patients (atrophic gastritis in 22, intestinal metaplasis in 9).The sensitivity of lesion detection by NBI was significantly higher than WLG (p⫽0.001). The kappa value
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1080i Wireless Biosensing of Upper Gastrointestinal Bleeding: A Paradigm Shift in Diagnosis and Treatment Marvin K. Ryou, Alex Nemiroski, Dan E. Azagury, Sohail N. Shaikh, Michele B. Ryan, Keith L. Obstein, Robert M. Westervelt, Christopher C. Thompson Introduction: Upper GI bleeding (UGIB) accounts for approximately 300,000 hospitalizations per year in the U.S. Rebleed rates following UGIB can be as high as 20%, even after endoscopic intervention, and can lead to higher morbidity and mortality. We have developed an endoscopically implantable wireless biosensor which detects acute GI hemorrhage and specifically re-bleeding. The sensor emits a wireless emergency signal to medical personnel using Bluetooth technology. Aims: To develop and test an endoscopically implantable wireless biosensor for detection of UGIB in ex vivo and in vivo porcine models. Methods: Both ex vivo and acute porcine bleeding experiments were performed. Ex vivo experiments evaluated (1) the biosensor’s sensitivity for detecting fresh porcine blood as a function of blood concentration of a fluorphore and pH content of gastric milieu; and (2) the biosensors’s ability to wirelessly transmit a signal through soft tissue while also submerged. Subsequently, laparotomies were performed on 5 Yorkshire pigs to create acute UGIB models by transmural fixation of the gastroepiploic artery across the anterior gastric wall. An FDAapproved fluorophore was then intravenously injected and biosensors were endoscopically placed in the stomach or duodenum using endoscopic clips. The surgically fixed artery was then lacerated. Estimated blood loss leading to sensor activation was recorded. Results: Benchtop results showed maximal sensitivity of the sensor at a fluorophore concentration of 0.05 mg/mL, maximal sensitivity at pH 2.0, and a 10:1 signal-to-noise ratio despite the presence of food and food dyes. A porcine UGIB model was successfully created. Biosensors functioned successfully in 5/5 cases. Average estimated blood loss leading to biosensor activation was 30 cc (10cc - 75 cc), and the sensor could distinguish between old and new blood. Biosensors were able to wirelessly transmit out of the body without incident and successfully sent an emergency text message to the intended cell phone in all cases. Conclusions: This endoscopically implantable wireless biosensor successfully detected acute hemorrhage in a porcine UGIB model. It was able to detect a small volume of fresh blood and subsequently transmit a wireless emergency signal to a cell phone. Endoscopic placement of a biosensor for GI bleeding surveillance could potentially limit morbidity,
AB144 GASTROINTESTINAL ENDOSCOPY
Volume 71, No. 5 : 2010
mortality, and health-care costs associated with post hemorrhage supportive care and rebleeding. Furthermore, it may allow adjustment of the management algorithm to lower acuity levels for various clinical scenarios.
1080j Full-Thickness Gastric Biopsy: A Novel Percutaneous Endoscopic Transenteric (PEATE) Approach in Humans With Gastroparesis Christopher N. Andrews, Hughie F. Fraser, Emil Neshev, Paul Mintchev, Martin Storr, Oliver F. Bathe, Stefan J. Urbanski Background and Aim: Recent evidence suggests disruption of the enteric nervous system (ENS) in full-thickness stomach specimens from patients with gastroparesis (GP). Currently, obtaining gastric ENS tissue is invasive, requiring a laparoscopy or laparotomy. We recently reported a novel, simple and reliable method to obtain full-thickness gastric biopsies during endoscopy using a dog model (GIE, in press) and have now translated this approach into humans.Methods: Five patients (4 female, mean age 49 y, range 38-65) with clinically diagnosed GP (2 diabetic, 3 idiopathic) fasted overnight and were given a single dose of cefazolin 2g IV prior to upper endoscopy (EGD) with conscious sedation. A suitable biopsy area was chosen based on indentation of the anterior stomach wall by external finger pressure on the abdominal skin and by transillumination with the endoscope. Using sterile technique, skin and biopsy tract were anesthetized with lidocaine 2% using a 22 gauge (G) tracking needle and entry into the stomach was endoscopically confirmed. A 4 mm incision was then made through the abdominal skin and a spring-loaded biopsy gun with a 14 G coaxial needle (15 cm long, 20mm throw length, 1.6mm internal diameter) was used to take 4 separate distal corpus biopsies from each patient. Patients were monitored for 4 hours prior to discharge. Histological elements were compared to archived normal gastric tissue from 13 control gastrectomies. Results: The procedure was well tolerated by all patients. The procedure was aborted in one patient (BMI 37) where transillumination failed and the stomach could not be reliably accessed with the tracking needle. The first patient biopsied had an endoclip placed due to mild post-biopsy oozing. Post-procedure hemoglobin levels were unchanged. No further intervention was required postbiopsy in the other 3 patients. There was no suggestion of peritonitis, bleeding, or significant discomfort in any of the patients at 4 days and 30 days postoperatively. Biopsies identified circular & longitudinal muscle, neurons, and Interstitial Cells of Cajal (ICC) with standard stains. Average biopsy size was approx. 1.5 by 5 mm, with 8 or more high-power fields (400x) assessable on each biopsy. Two idiopathic GP patients had reduced ICC counts compared to controls.Conclusions: This study confirms the feasibility and preliminary safety of the novel PEATE biopsy technique in human patients. This minimally-invasive and simple method may allow for routine assessment of gastric ENS tissues in patients with suspected motility disorders. Funded in part by CLS R&D grant RE7133.
1080k Narrow Band Imaging vs. White Light Gastroscopy in Detecting Gastric Premalignant and Early Malignant Lesions: A Randomized Prospective Crossover Study Ashok Chacko, Amit Dutta, Kattiparambil G. Sajith Introduction: Narrow band imaging (NBI) detects mucosal surface details (pit pattern) as well as the microvasculature details of mucosa. In premalignant and early malignant conditions the pattern and regularity of pits and microvasculature are altered. Patients above 45 years of age with dyspeptic symptoms have higher risk of gastric malignancy than younger patients.Aims & Methods: We aimed to assess whether narrow band imaging is superior to conventional white light gastroscopy (WLG) in detecting gastric premalignant and early malignant lesions in patients above 45 years with dyspepsia. We conducted a randomized prospective crossover study from January 2009 to July 2009 at CMC, Vellore in India. Patients above 45 years of age with dyspepsia (ROME III criteria) in absence of alarm symptoms underwent gastric mucosal examination using WLG and NBI in same session by different endoscopists who were blinded to each others finding. Biopsy was taken if needed at the end of second scopy after a third observer reviewed report of both scopists. The sequence of scopies (WLG or NBI first) was determined by block randomization. The total yield of gastric premalignant lesions (atrophic gastritis, intestinal metaplasia, dysplasia, adenomatous polyp) and early malignancy was estimated for both. Comparison of sensitivities of the two screening tests was done using McNemar’s test. Kappa test was done to assess agreement between the two tests. The study was approved by institute review board and ethics committee. Results: A total of 200 (Males-132) patients participated in the study after giving written informed consent. The mean age was 52.3⫹6.4 years. The total number of patients diagnosed to have premalignant lesions by any of the two modalities were 32. No patient had early gastric cancer. WLG detected lesions in 17 patients (atrophic gastritis in 12, intestinal metaplasia in7,) and NBI in 31 patients (atrophic gastritis in 22, intestinal metaplasis in 9).The sensitivity of lesion detection by NBI was significantly higher than WLG (p⫽0.001). The kappa value
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