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Severe Complications of Spiral Enteroscopy in the First 1750 Patients
Abstracts
803 Is Endoscopic Ultrasound Guided Brachytherapy (EUS-BrTx) Useful for the Treatment of Recurrent Malignant Lymph Nodes? Reiko Ashida, Susumu Shinoura, Makoto Nishimura, Raman Muthusamy, John G. Lee, Kenneth J. Chang Background: Brachytherapy is an established treatment for various cancers such as head and neck, lung, and most commonly prostate cancer. For GI malignancies, brachytherapy has been used for esophageal, pancreatic and rectal cancer. Although it has many advantages (minimal toxicity to surrounding organs, single session delivery, etc) one of its major limitations is delivery access. EUS-guided Brachytherapy (EUS-BrTx) is a newly reported technique. However, outcomes data is limited. We report our experience with EUS-BrTx in 5 patients with recurrent cancer. Patient and Method: Four patients with esophageal cancer and one patient with duodenal cancer had pathologically confirmed recurrent malignant lymph nodes. EUS-BrTx was performed as part of an IRB approved protocol using 19G FNA needle (Cook Medical Inc, Bloomington, IN)) and either iodine I125 or palladium Pd103 seeds. Four patients required only a single session while one patient underwent four sessions for recurrent LNs over a span of 9 months. A total of 11 LNs were treated. Two patients had chemotherapy following EUS-BrTx. Result: All LNs were successfully implanted with radioactive seeds via EUS without any procedure related complications. The median size of LNs was 16.2 x 10.5 mm(range 9.5 x 8.2 - 35.9 x 37.0mm). The median number of implanted seeds was 3.5 (1 - 12). On follow up EUS or CT, seven out of 11 LNs(63.6 %) showed decrease in size or disappearance. Two out of 11 LNs (18.2%) did not change in size and 2 out of 11 LNs(18.2%) showed increase in size. Three patients are still alive without any signs of recurrence with a mean survival of 11 months from time of EUS-BrTx. Conclusion: EUS-BrTx is a safe and feasible procedure with an 82% control rate for locally recurrent LNs in a small series.
No of Case1 LN 1
Disease Eso CA
2 3 4 5 6 Case2 7
Eso CA
Case3 8
Eso CA
Case4 9
Eso CA
10 Case5 11
Size of LN (pre)
Size of LN (post)
12.5 x 7.8(mm) 13.5 x 7.7 10.3 x 9.3 15.0 x 7.0 18.0 x 7.0 15.0 x 10.0 17.1 x 5.7 20.0 x 10.0 9.5 x 8.2
8.2 x 3.0 (mm) 4.7 x 3.2
Eso CA
11.5 x 5.9 Duodenal 35.9 x CA 37.0
14.0 x 9.9 30.0 x 12.0 19.0 x 4.0 not detected not detected 20.0 x 10.0 not detected not detected not detected
Change No of Combination Survival seeds therapy Y
2
N/A
Y
1
N/A
[
2
N/A
[
2
N/A
Z
2
N/A
Y
2
N/A
Y
2
N/A
Z
9
N/A
Y
3
Chemo
Y
2
Chemo
Y
12
Chemo
6 mo dead
24 mo dead 14 mo alive 8 mo alive
12 mo alive
915 Prospective Multicenter Trial Comparing Double Balloon Enteroscopy (DBE) and Single Balloon Enteroscopy (SBE) in Patients with Suspected Small Bowel Disorder Andrea May, Michael Fa¨Rber, Insa Aschmoneit, Juergen Pohl, Hendrik Manner, Erich Lotterer, Oliver Moeschler, Liebwin Gossner, Klaus Mo ¨Nkemu ¨ Ller, Martin Raithel, Stephan Miehlke, Christian Ell Background: DBE has become established throughout the world for diagnostic and therapeutic small bowel endoscopy. SBE has been introduced as a simplification of the balloon enteroscopy technique.Objective/Study Design: Prospective comparison of the double and single ballon technique of small bowel endoscopy. Complete enteroscopy was choosen as study endpoint, because it is the most objective parameter. DBE was considered to reach more than double a complete enteroscopy compared to SBE (40% versus 15%). Number of patients needed to be investigated for this hypothesis was calculated with 98 randomised patients. Only diagnostic or therapeutic examinations with argon plasma coagulation up to 5 angiodysplasias were included. Patients with prior colon and small bowel surgery had been excluded. Material and Methods: 117 pats. had been enrolled into the study, after exclusion of 17 patients (e.g. due to tumor stenosis, necessary therapeutic interventions etc.) 100 pats. (50 for each group) (63 male, 37 female)
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with a mean age of 55 years finished the study successfully. Reason for small bowel endoscopy had been (suspected) mid GI bleeding (nZ60), (suspected) Crohn’s disease (nZ 12), suspected small bowel masses (nZ7) and others (nZ21). For small bowel endoscopy the Fujinon device (EN450-P5) was used either with two or with one balloon. Results: All balloon enteroscopies had been performed without severe complications. The preparation time of the SBE device had been significantly (p!0.0001) faster compared with the DBE device. There was no significant difference regarding the investigation time. Complete enteroscopy was done with the DBE device in 66 % (33 patients) either with the oral route alone or with combination of oral and anal approach, whereas with the SBE device the rate was significantly (p!0.0001) less with 22% (11 patients, only combination of oral and anal route). The diagnostic yield regarding relevant findings had been 50% using DBE and 42% using SBE. Not included in this diagnostic yield rate are the normal examinations for exclusion of relevant findings or determination of the extension of a known disease, where only a complete small bowel endoscopy can give this important information. Conclusion: With the DBE technique the rate of complete enteroscopy had been approximately three fold higher than with the SBE technique going along with a higher diagnostic yield. Therefore DBE must continue to be regarded as the gold standard procedure for deep small bowel endoscopy.
916 Severe Complications of Spiral Enteroscopy in the First 1750 Patients Paul A. Akerman, Daniel Cantero Serious complications of deep small bowel enteroscopy occur infrequently. In published series, severe complications occur in deep small bowel enteroscopy in 0.3 to 4% of cases. The aim of this study is to publish all recognized serious complications occuring during spiral enteroscopy. Patients, Methods, and Materials: There were 1750 patients who underwent spiral enteroscopy from August,2005 until November 2008. Cases have been performed in North America and Europe. Data was collected from device representatives and a survey of device users. The device used in all cases was the Discovery SB which is 118 cm long with a hollow spiral 5.5 mm high and 22 cm long with a scope coupler on the proximal end. The Discovery SB has an outer diameter of 16 mm and an internal diameter of 9.8 mm. The enteroscopes used in the examinations were 9.2 mm Olympus SIF-180 and 9.4 mm Fujinon EN450T-5 200 cm enteroscopes. Severe complications were defined as pancreatitis, nontransient intussusception, severe pain after the procedure requiring admission to the hospital, bleeding requiring transfusion or admission to the hospital, cardio-pulmonary arrest during a procedure and perforation. Results: There were no reported complications of pancreatitis, esophageal or gastric perforations, severe bleeding requiring transfusion, cardio-pulmonary arrests or deaths during or resulting from the spiral enteroscopy procedures. There were 7 severe complications(0.4%) reported as a result of the procedure. Six were small bowel perforations(0.34%). All were recognized immediately when the scope tip entered the peritoneum. Of these, three small bowel perforations occured in the duodenum and three occurred in the jejunum. All perforations occurred while pushing to advance the scope through the stationary overtube. None of the perforations occured during therapeutic interventions. None of the perforations occurred during rotation of the overtube to pleat the small bowel. Three of the perforations occurred when the experience of the physician was less than 10 cases. One patient experienced severe pain after the procedure and was admitted for observation. The patient did not require intervention and was later discharged. Conclusion: The overall severe complication rate was 0.4% and a perforation rate of 0.34%. All of the perforations were recognized immediately when the scope tip visualized the peritoneum. Perforations may be minimized by advancing the enteroscope only when the lumen is clearly visualized.
917 Spiral Enteroscopy: Prospective Multicenter U.S. Trial in Patients with Small Bowel Disorders Douglas Morgan, Bennie R. Upchurch, Peter V. Draganov, Kenneth F. Binmoeller, Oleh Haluszka, Sreenivasa Jonnalagadda, Patrick Okolo, Ian S. Grimm, Michael V. Chiorean Background: Deep enteroscopy (DBE, SBE) has revolutionized management of patients with mid-small bowel disorders. Spiral enteroscopy(SE) is a novel approach coupling a standard balloon enteroscope with a spiral overtube. Aims of the present study were to determine the performance, yield and safety of SE in patients with suspected or established small bowel pathology. Methods: Prospective, multicenter study with centralized standard database. Patients referred for anterograde enteroscopy were eligible. Patients with a history of esophageal stricture, advanced cirrhosis, or coagulopathy were excluded. The depth of insertion was measured using a standard algorithm. The mean adjusted diagnostic procedure time was calculated for all procedures: total time minus therapy time. Results: 148 patients were enrolled at 10 centers in the U.S. with a median age of 68 (42% male). Co-morbid conditions were common: CAD 37.4%, CHF 12%, COPD 16%, prior abdominal/pelvic surgery 55%. Chronic medication use: ASA 27%, clopidogrel 12%, warfarin 6.3%. Obscure GI bleeding(72%) was the most common indication, of which 32% were overt and 62% had been transfused within 6 months.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB127
803 Is Endoscopic Ultrasound Guided Brachytherapy (EUS-BrTx) Useful for the Treatment of Recurrent Malignant Lymph Nodes? Reiko Ashida, Susumu Shinoura, Makoto Nishimura, Raman Muthusamy, John G. Lee, Kenneth J. Chang Background: Brachytherapy is an established treatment for various cancers such as head and neck, lung, and most commonly prostate cancer. For GI malignancies, brachytherapy has been used for esophageal, pancreatic and rectal cancer. Although it has many advantages (minimal toxicity to surrounding organs, single session delivery, etc) one of its major limitations is delivery access. EUS-guided Brachytherapy (EUS-BrTx) is a newly reported technique. However, outcomes data is limited. We report our experience with EUS-BrTx in 5 patients with recurrent cancer. Patient and Method: Four patients with esophageal cancer and one patient with duodenal cancer had pathologically confirmed recurrent malignant lymph nodes. EUS-BrTx was performed as part of an IRB approved protocol using 19G FNA needle (Cook Medical Inc, Bloomington, IN)) and either iodine I125 or palladium Pd103 seeds. Four patients required only a single session while one patient underwent four sessions for recurrent LNs over a span of 9 months. A total of 11 LNs were treated. Two patients had chemotherapy following EUS-BrTx. Result: All LNs were successfully implanted with radioactive seeds via EUS without any procedure related complications. The median size of LNs was 16.2 x 10.5 mm(range 9.5 x 8.2 - 35.9 x 37.0mm). The median number of implanted seeds was 3.5 (1 - 12). On follow up EUS or CT, seven out of 11 LNs(63.6 %) showed decrease in size or disappearance. Two out of 11 LNs (18.2%) did not change in size and 2 out of 11 LNs(18.2%) showed increase in size. Three patients are still alive without any signs of recurrence with a mean survival of 11 months from time of EUS-BrTx. Conclusion: EUS-BrTx is a safe and feasible procedure with an 82% control rate for locally recurrent LNs in a small series.
No of Case1 LN 1
Disease Eso CA
2 3 4 5 6 Case2 7
Eso CA
Case3 8
Eso CA
Case4 9
Eso CA
10 Case5 11
Size of LN (pre)
Size of LN (post)
12.5 x 7.8(mm) 13.5 x 7.7 10.3 x 9.3 15.0 x 7.0 18.0 x 7.0 15.0 x 10.0 17.1 x 5.7 20.0 x 10.0 9.5 x 8.2
8.2 x 3.0 (mm) 4.7 x 3.2
Eso CA
11.5 x 5.9 Duodenal 35.9 x CA 37.0
14.0 x 9.9 30.0 x 12.0 19.0 x 4.0 not detected not detected 20.0 x 10.0 not detected not detected not detected
Change No of Combination Survival seeds therapy Y
2
N/A
Y
1
N/A
[
2
N/A
[
2
N/A
Z
2
N/A
Y
2
N/A
Y
2
N/A
Z
9
N/A
Y
3
Chemo
Y
2
Chemo
Y
12
Chemo
6 mo dead
24 mo dead 14 mo alive 8 mo alive
12 mo alive
915 Prospective Multicenter Trial Comparing Double Balloon Enteroscopy (DBE) and Single Balloon Enteroscopy (SBE) in Patients with Suspected Small Bowel Disorder Andrea May, Michael Fa¨Rber, Insa Aschmoneit, Juergen Pohl, Hendrik Manner, Erich Lotterer, Oliver Moeschler, Liebwin Gossner, Klaus Mo ¨Nkemu ¨ Ller, Martin Raithel, Stephan Miehlke, Christian Ell Background: DBE has become established throughout the world for diagnostic and therapeutic small bowel endoscopy. SBE has been introduced as a simplification of the balloon enteroscopy technique.Objective/Study Design: Prospective comparison of the double and single ballon technique of small bowel endoscopy. Complete enteroscopy was choosen as study endpoint, because it is the most objective parameter. DBE was considered to reach more than double a complete enteroscopy compared to SBE (40% versus 15%). Number of patients needed to be investigated for this hypothesis was calculated with 98 randomised patients. Only diagnostic or therapeutic examinations with argon plasma coagulation up to 5 angiodysplasias were included. Patients with prior colon and small bowel surgery had been excluded. Material and Methods: 117 pats. had been enrolled into the study, after exclusion of 17 patients (e.g. due to tumor stenosis, necessary therapeutic interventions etc.) 100 pats. (50 for each group) (63 male, 37 female)
www.giejournal.org
with a mean age of 55 years finished the study successfully. Reason for small bowel endoscopy had been (suspected) mid GI bleeding (nZ60), (suspected) Crohn’s disease (nZ 12), suspected small bowel masses (nZ7) and others (nZ21). For small bowel endoscopy the Fujinon device (EN450-P5) was used either with two or with one balloon. Results: All balloon enteroscopies had been performed without severe complications. The preparation time of the SBE device had been significantly (p!0.0001) faster compared with the DBE device. There was no significant difference regarding the investigation time. Complete enteroscopy was done with the DBE device in 66 % (33 patients) either with the oral route alone or with combination of oral and anal approach, whereas with the SBE device the rate was significantly (p!0.0001) less with 22% (11 patients, only combination of oral and anal route). The diagnostic yield regarding relevant findings had been 50% using DBE and 42% using SBE. Not included in this diagnostic yield rate are the normal examinations for exclusion of relevant findings or determination of the extension of a known disease, where only a complete small bowel endoscopy can give this important information. Conclusion: With the DBE technique the rate of complete enteroscopy had been approximately three fold higher than with the SBE technique going along with a higher diagnostic yield. Therefore DBE must continue to be regarded as the gold standard procedure for deep small bowel endoscopy.
916 Severe Complications of Spiral Enteroscopy in the First 1750 Patients Paul A. Akerman, Daniel Cantero Serious complications of deep small bowel enteroscopy occur infrequently. In published series, severe complications occur in deep small bowel enteroscopy in 0.3 to 4% of cases. The aim of this study is to publish all recognized serious complications occuring during spiral enteroscopy. Patients, Methods, and Materials: There were 1750 patients who underwent spiral enteroscopy from August,2005 until November 2008. Cases have been performed in North America and Europe. Data was collected from device representatives and a survey of device users. The device used in all cases was the Discovery SB which is 118 cm long with a hollow spiral 5.5 mm high and 22 cm long with a scope coupler on the proximal end. The Discovery SB has an outer diameter of 16 mm and an internal diameter of 9.8 mm. The enteroscopes used in the examinations were 9.2 mm Olympus SIF-180 and 9.4 mm Fujinon EN450T-5 200 cm enteroscopes. Severe complications were defined as pancreatitis, nontransient intussusception, severe pain after the procedure requiring admission to the hospital, bleeding requiring transfusion or admission to the hospital, cardio-pulmonary arrest during a procedure and perforation. Results: There were no reported complications of pancreatitis, esophageal or gastric perforations, severe bleeding requiring transfusion, cardio-pulmonary arrests or deaths during or resulting from the spiral enteroscopy procedures. There were 7 severe complications(0.4%) reported as a result of the procedure. Six were small bowel perforations(0.34%). All were recognized immediately when the scope tip entered the peritoneum. Of these, three small bowel perforations occured in the duodenum and three occurred in the jejunum. All perforations occurred while pushing to advance the scope through the stationary overtube. None of the perforations occured during therapeutic interventions. None of the perforations occurred during rotation of the overtube to pleat the small bowel. Three of the perforations occurred when the experience of the physician was less than 10 cases. One patient experienced severe pain after the procedure and was admitted for observation. The patient did not require intervention and was later discharged. Conclusion: The overall severe complication rate was 0.4% and a perforation rate of 0.34%. All of the perforations were recognized immediately when the scope tip visualized the peritoneum. Perforations may be minimized by advancing the enteroscope only when the lumen is clearly visualized.
917 Spiral Enteroscopy: Prospective Multicenter U.S. Trial in Patients with Small Bowel Disorders Douglas Morgan, Bennie R. Upchurch, Peter V. Draganov, Kenneth F. Binmoeller, Oleh Haluszka, Sreenivasa Jonnalagadda, Patrick Okolo, Ian S. Grimm, Michael V. Chiorean Background: Deep enteroscopy (DBE, SBE) has revolutionized management of patients with mid-small bowel disorders. Spiral enteroscopy(SE) is a novel approach coupling a standard balloon enteroscope with a spiral overtube. Aims of the present study were to determine the performance, yield and safety of SE in patients with suspected or established small bowel pathology. Methods: Prospective, multicenter study with centralized standard database. Patients referred for anterograde enteroscopy were eligible. Patients with a history of esophageal stricture, advanced cirrhosis, or coagulopathy were excluded. The depth of insertion was measured using a standard algorithm. The mean adjusted diagnostic procedure time was calculated for all procedures: total time minus therapy time. Results: 148 patients were enrolled at 10 centers in the U.S. with a median age of 68 (42% male). Co-morbid conditions were common: CAD 37.4%, CHF 12%, COPD 16%, prior abdominal/pelvic surgery 55%. Chronic medication use: ASA 27%, clopidogrel 12%, warfarin 6.3%. Obscure GI bleeding(72%) was the most common indication, of which 32% were overt and 62% had been transfused within 6 months.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB127