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Transnasal Versus Oral PEG Placement in Unselected Patients: A Prospective Randomized Clinical Trial
Abstracts
patients at Memorial Sloan- Kettering Cancer Center from January 1, 2003 and August 26, 2008 who received Bevacizumab within sixty days before or after endoluminal stent placement. Data collected included demographics, underlying cancer, location of obstruction, immediate and delayed perforations. Results: Thirty seven patients were identified in which 41 endoluminal stents were placed. There were 19 women and 18 men. Mean age was 58.5 years (range 26-76 years). Underlying cancers included colorectal (25), ovarian (3), esophageal (4), and other (5). Stent locations were: 19 rectal, 1 sigmoid colon, 8 transverse colon, 2 hepatic flexure, 5 esophageal, 4 gastrojejunostomy, 1 duodenal and 1 pyloric. There were a total of 5 perforations, one immediate and four delayed. The patient with the immediate perforation had not yet received Bevacizumab indicating a procedural complication. Four patients had delayed perforations. All of these occurred at the site of the tumor and stent (two transverse colon and two rectal). One perforation happened four days after stent placement and 7 days after Bevacizumab. Operative findings revealed extensive carcinomatosis and massively dilated small and large bowel. The remaining 3 patients perforated 1 month, 2 months, and 4 months after stent placement and 4 days, 3 days, and 15 days after Bevacizumab, respectively. None of these patients had bowel obstruction at the time of perforation and all underwent operative management. The overall rate of delayed perforation rate is 10.8%. Conclusion Endoluminal stent placement in the setting of concomitant Bevacizumab is associated with a delayed perforation rate of approximately 11%. Careful consideration should be given to use of Bevacizumab in patients with endoluminal stents.
M1334 The Diagnostic Effect of Capsule Endoscopy in 31 Cases with Subacute Small Bowel Obstruction Chunxiao Chen, Xiaoyun Yang Background: Although small bowel obstruction or strictures were considered to be a contraindication to capsule endoscopy in many centers, we noted that the accuracy of radiography in this situation has often been questioned. The aim of this study was to evaluate the effectiveness and safety of capsule endoscopy in patients with recurrent subacute small bowel obstruction (SBO). Patients and Methods: A retrospective analysis of 31 patients who underwent capsule endoscopy was performed . The patients were referred to hospital from January 2003 to August 2008 for the investigation of subacute small bowel obstruction. The patients were 9 to 81 years old, and all of them had undergone gastroscopy and colonoscopy previously. Some of them had undergone abdominal CT or small bowel followthrough. Results: Capsule endoscopy made a definitive diagnosis in 12 of 31 cases (38.7%): 4 Crohn’s disease, 2 carcinomas, 1 intestinal tuberculosis, 1 ischemic enteritis, 1 abdominal cocoon, 1 duplication of intestine, 1 diverticulum of small intestine and 1 ileal polypoid tumor. Capsule retention occurred in 3 of 31 patients (9.7%) including 2 Crohn’s disease and 1 tumor. Two retained capsules were retrieved at surgery, and another one spontaneously passed the stricture by medical treatment in 6 months. There was no case in which administration of the capsule endoscopy led to an acute small bowel obstruction. Conclusions: Capsule endoscopy provided a safe, effective and excellent visualization way to identify the etiology of a subacute small bowel obstruction, especially for the patients with suspected intestinal tumors or CD, which are not identified by routine examinations.
M1335 Transnasal Versus Oral PEG Placement in Unselected Patients: A Prospective Randomized Clinical Trial Italo Stroppa, Raffaella Lionetti, Andrea Cocco, Fabio Andrei, Mario Erboso, Francesco Pallone Background and Aims: Conventional transoral PEG (O-PEG) is not always possible to perform due to neurological or oro-pharyngeal diseases so a feeding tube can be inserted only by a transnasal approach (TN-PEG). Antibiotic prophylaxis is recommended to prevent peristomal wound infections (incidence 4-30%) before OPEG but its role is not yet well defined before TN-PEG. The aims of this study were to assess the feasibility, safety and effectiveness of TN-PEG placement in unselected population and to investigate whether antibiotic prophylaxis is mandatory for TNPEG. Patients and Methods: 60 consecutive adult patients were randomized in order to receive O-PEG (Group A, nZ20; M 15, F 5; mean age 65; range 18-91) or TN-PEG (Group B, nZ40; M 22, F 18; mean age 60; range 24-92) in proportion 1: 2. The indications for PEG were cerebrovascular accidents in 26 (43.4%), trauma in 14 (23.3%), neurological/degenerative diseases in 15 (25%) and esophagus/ oropharyngeal cancer in 5 patients (8.3%). Patients in Group A received antibiotic prophylaxis while patients in Group B were equally randomized to receive (Group B1) or not (Group B2) antibiotic prophylaxis (cefazolin 1 g IV 30 minutes before the procedure). All patients did not receive antibiotics at least 48 hours before PEG insertion. All PEG were placed using the pull-through technique. Enteral nutrition was started on the second day after the PEG insertion. Patients were followed-up for 30 days. Fisher’s exact test was used for statistical analysis. Results: PEG was successfully placed in all 60 patients. Peristomal wound infections were described in five (8.3%) patients: 2 in Group A, 2 in Group B1 and 1 in Group B2. No statistically significant differences in term of sex and age of patients, indications, duration of the procedure and complications resulted between Groups A and B and between
AB216 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
Groups B1 and B2. No major complications occurred in our patients. Conclusions: TN-PEG procedure resulted comparable to O-PEG in term of feasibility, safety and effectiveness and can be used in unselected patients without administration of antibiotic prophylaxis.
M1336 Deep Sedation in Advanced Endoscopy: Frequency and Clinical Characteristics of Patients Who Require Airway Modifications Gregory A. Cote, Robert M. Hovis, Michael Ansstas, Lawrence Waldbaum, Riad R. Azar, Steven A. Edmundowicz, Daniel Mullady, Sreenivasa Jonnalagadda Background: When administered by a trained professional, the safety and efficacy of propofol in advanced endoscopy is well described. While use of propofol requires advanced airway training, it is unclear how frequently airway modifications are employed during endoscopy and which patients may be most susceptible. Objectives: Define the frequency of airway modifications (AMs) and clinical characteristics of patients who require AMs during advanced endoscopic procedures. Methods: Patients referred for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS) and small bowel enteroscopy (SBE), were prospectively enrolled. Sedative dosing and patient monitoring was determined by a certified registered nurse anesthetist (CRNA). Clinical, pharmacological and endoscopic characteristics were recorded. The primary outcome variable was frequency of one or more AMs, defined as chin lift, modified mask ventilation, nasal airway, bag-mask ventilation and endotracheal intubation. Characteristics of patients who required one or more AMs (AMþ) were compared to those who did not require any maneuvers (AM-). Results: 629 patients were enrolled between May, 2008 and September, 2008. 40.8% received propofol alone while 59.2% received propofol in combination with low dose opiate and/or benzodiazepine. Procedures included EUS (329), ERCP (268), and SBE or other (38). All patients met criteria for deep sedation. While only 11.5% of patients developed a pulse oximetry of !90%, one or more AMs were performed in 101 (16.1%) patients, including chin lift (86), modified mask ventilation (27), placement of a nasal airway (24), or some combination. No patients required bagmask ventilation or endotracheal intubation. Three patients developed hypotension requiring transient use of vasopressors. There were no other significant cardiopulmonary complications. Mean body mass index (kg/m2) was significantly higher among AMþ (29.5 7.4) compared to AM- (26.7 6.5) patients (pZ0.0001). Induction and total propofol doses (mg/kg/min), use of propofol in combination with other sedatives, procedure time, prone position, ASA class, and Malampati scores were similar across both groups. Conclusion: Despite a low rate of cardiopulmonary complications, 16.1% of patients undergoing advanced endoscopic procedures required one or more maneuvers to maintain a stable airway. Higher BMI was a predictor of requiring AMs, but dose of propofol and its use in combination with other sedatives were not. For the safe administration of propofol in advanced endoscopy, advanced airway training is warranted.
M1337 The Efficacy of Retrograde Deep Insertion of Single Balloon Endoscopy for Patients with Crohn’s Disease At Times of Conventional Colonoscopy On Outpatients: Prospective, OpenLabel, Feasibility Study Kenji Watanabe, Mitsue Sogawa, Shuhei Hosomi, Kenichi Morimoto, Takehisa Suekane, Noriko Kamata, Natsuhiko Kameda, Hirohisa Machida, Hirotoshi Okazaki, Tetsuya Tanigawa, Hirokazu Yamagami, Kazunari Tominaga, Toshio Watanabe, Yasuhiro Fujiwara, Nobuhide Oshitani, Tetsuo Arakawa Background: The significance of mucosal healing in patients with Crohn’s disease (CD) following treatment with several biologic agents has recieved attention for better patient prognosis recently. But there are some difficulties or problems with endoscopic detection of small bowel CD lesions (e.g. retention, incomplete examination for deep insertion) in spite of the development of capsule endoscopy and double balloon endoscopy. We investigated the efficacy and safety of single balloon endoscopy (SBE) for the purpose of detection of lesions from the upper part to the middle part of ileal and whole colonic lesions at times of conventional colonoscopic examinations on outpatients. Subjects and Methods: We evaluated 25 cases of CD outpatients (L1: 3, L2: 3, L3: 19; 12 cases had history of operations.) who had received retrograde deep insertion of SBE and small bowel barium study (SBBS). We compared both findings prospectively. We scored the findings from the upper part to the middle part of the ileum, the terminal ileum or ileocolonic anastomotic lesions and colonic lesions separately (Gut 2006; 55: 842, altered). Results: The deepest insertion point of SBE was in the upper part of the ileum in 7 cases (28.0%), in the middle part of the ileum in 15 cases (60.0%) and in the lower part of the ileum in 3 cases (12.0%). The average examination time of SBE was 40m01s (24 m 25 s-58 m 18 s) and there were no complications. The examination was performed in 21 cases (84.0%) by two physicians and in 4 cases (16.0%) by one physician. CO2 insufflation was used in 6 cases. Fourteen cases (56.0%) had new CD lesions in the upper or middle part of the ileum compared with observations limited to the terminal ileum and colon. There were more active lesions in 4 cases
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patients at Memorial Sloan- Kettering Cancer Center from January 1, 2003 and August 26, 2008 who received Bevacizumab within sixty days before or after endoluminal stent placement. Data collected included demographics, underlying cancer, location of obstruction, immediate and delayed perforations. Results: Thirty seven patients were identified in which 41 endoluminal stents were placed. There were 19 women and 18 men. Mean age was 58.5 years (range 26-76 years). Underlying cancers included colorectal (25), ovarian (3), esophageal (4), and other (5). Stent locations were: 19 rectal, 1 sigmoid colon, 8 transverse colon, 2 hepatic flexure, 5 esophageal, 4 gastrojejunostomy, 1 duodenal and 1 pyloric. There were a total of 5 perforations, one immediate and four delayed. The patient with the immediate perforation had not yet received Bevacizumab indicating a procedural complication. Four patients had delayed perforations. All of these occurred at the site of the tumor and stent (two transverse colon and two rectal). One perforation happened four days after stent placement and 7 days after Bevacizumab. Operative findings revealed extensive carcinomatosis and massively dilated small and large bowel. The remaining 3 patients perforated 1 month, 2 months, and 4 months after stent placement and 4 days, 3 days, and 15 days after Bevacizumab, respectively. None of these patients had bowel obstruction at the time of perforation and all underwent operative management. The overall rate of delayed perforation rate is 10.8%. Conclusion Endoluminal stent placement in the setting of concomitant Bevacizumab is associated with a delayed perforation rate of approximately 11%. Careful consideration should be given to use of Bevacizumab in patients with endoluminal stents.
M1334 The Diagnostic Effect of Capsule Endoscopy in 31 Cases with Subacute Small Bowel Obstruction Chunxiao Chen, Xiaoyun Yang Background: Although small bowel obstruction or strictures were considered to be a contraindication to capsule endoscopy in many centers, we noted that the accuracy of radiography in this situation has often been questioned. The aim of this study was to evaluate the effectiveness and safety of capsule endoscopy in patients with recurrent subacute small bowel obstruction (SBO). Patients and Methods: A retrospective analysis of 31 patients who underwent capsule endoscopy was performed . The patients were referred to hospital from January 2003 to August 2008 for the investigation of subacute small bowel obstruction. The patients were 9 to 81 years old, and all of them had undergone gastroscopy and colonoscopy previously. Some of them had undergone abdominal CT or small bowel followthrough. Results: Capsule endoscopy made a definitive diagnosis in 12 of 31 cases (38.7%): 4 Crohn’s disease, 2 carcinomas, 1 intestinal tuberculosis, 1 ischemic enteritis, 1 abdominal cocoon, 1 duplication of intestine, 1 diverticulum of small intestine and 1 ileal polypoid tumor. Capsule retention occurred in 3 of 31 patients (9.7%) including 2 Crohn’s disease and 1 tumor. Two retained capsules were retrieved at surgery, and another one spontaneously passed the stricture by medical treatment in 6 months. There was no case in which administration of the capsule endoscopy led to an acute small bowel obstruction. Conclusions: Capsule endoscopy provided a safe, effective and excellent visualization way to identify the etiology of a subacute small bowel obstruction, especially for the patients with suspected intestinal tumors or CD, which are not identified by routine examinations.
M1335 Transnasal Versus Oral PEG Placement in Unselected Patients: A Prospective Randomized Clinical Trial Italo Stroppa, Raffaella Lionetti, Andrea Cocco, Fabio Andrei, Mario Erboso, Francesco Pallone Background and Aims: Conventional transoral PEG (O-PEG) is not always possible to perform due to neurological or oro-pharyngeal diseases so a feeding tube can be inserted only by a transnasal approach (TN-PEG). Antibiotic prophylaxis is recommended to prevent peristomal wound infections (incidence 4-30%) before OPEG but its role is not yet well defined before TN-PEG. The aims of this study were to assess the feasibility, safety and effectiveness of TN-PEG placement in unselected population and to investigate whether antibiotic prophylaxis is mandatory for TNPEG. Patients and Methods: 60 consecutive adult patients were randomized in order to receive O-PEG (Group A, nZ20; M 15, F 5; mean age 65; range 18-91) or TN-PEG (Group B, nZ40; M 22, F 18; mean age 60; range 24-92) in proportion 1: 2. The indications for PEG were cerebrovascular accidents in 26 (43.4%), trauma in 14 (23.3%), neurological/degenerative diseases in 15 (25%) and esophagus/ oropharyngeal cancer in 5 patients (8.3%). Patients in Group A received antibiotic prophylaxis while patients in Group B were equally randomized to receive (Group B1) or not (Group B2) antibiotic prophylaxis (cefazolin 1 g IV 30 minutes before the procedure). All patients did not receive antibiotics at least 48 hours before PEG insertion. All PEG were placed using the pull-through technique. Enteral nutrition was started on the second day after the PEG insertion. Patients were followed-up for 30 days. Fisher’s exact test was used for statistical analysis. Results: PEG was successfully placed in all 60 patients. Peristomal wound infections were described in five (8.3%) patients: 2 in Group A, 2 in Group B1 and 1 in Group B2. No statistically significant differences in term of sex and age of patients, indications, duration of the procedure and complications resulted between Groups A and B and between
AB216 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
Groups B1 and B2. No major complications occurred in our patients. Conclusions: TN-PEG procedure resulted comparable to O-PEG in term of feasibility, safety and effectiveness and can be used in unselected patients without administration of antibiotic prophylaxis.
M1336 Deep Sedation in Advanced Endoscopy: Frequency and Clinical Characteristics of Patients Who Require Airway Modifications Gregory A. Cote, Robert M. Hovis, Michael Ansstas, Lawrence Waldbaum, Riad R. Azar, Steven A. Edmundowicz, Daniel Mullady, Sreenivasa Jonnalagadda Background: When administered by a trained professional, the safety and efficacy of propofol in advanced endoscopy is well described. While use of propofol requires advanced airway training, it is unclear how frequently airway modifications are employed during endoscopy and which patients may be most susceptible. Objectives: Define the frequency of airway modifications (AMs) and clinical characteristics of patients who require AMs during advanced endoscopic procedures. Methods: Patients referred for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS) and small bowel enteroscopy (SBE), were prospectively enrolled. Sedative dosing and patient monitoring was determined by a certified registered nurse anesthetist (CRNA). Clinical, pharmacological and endoscopic characteristics were recorded. The primary outcome variable was frequency of one or more AMs, defined as chin lift, modified mask ventilation, nasal airway, bag-mask ventilation and endotracheal intubation. Characteristics of patients who required one or more AMs (AMþ) were compared to those who did not require any maneuvers (AM-). Results: 629 patients were enrolled between May, 2008 and September, 2008. 40.8% received propofol alone while 59.2% received propofol in combination with low dose opiate and/or benzodiazepine. Procedures included EUS (329), ERCP (268), and SBE or other (38). All patients met criteria for deep sedation. While only 11.5% of patients developed a pulse oximetry of !90%, one or more AMs were performed in 101 (16.1%) patients, including chin lift (86), modified mask ventilation (27), placement of a nasal airway (24), or some combination. No patients required bagmask ventilation or endotracheal intubation. Three patients developed hypotension requiring transient use of vasopressors. There were no other significant cardiopulmonary complications. Mean body mass index (kg/m2) was significantly higher among AMþ (29.5 7.4) compared to AM- (26.7 6.5) patients (pZ0.0001). Induction and total propofol doses (mg/kg/min), use of propofol in combination with other sedatives, procedure time, prone position, ASA class, and Malampati scores were similar across both groups. Conclusion: Despite a low rate of cardiopulmonary complications, 16.1% of patients undergoing advanced endoscopic procedures required one or more maneuvers to maintain a stable airway. Higher BMI was a predictor of requiring AMs, but dose of propofol and its use in combination with other sedatives were not. For the safe administration of propofol in advanced endoscopy, advanced airway training is warranted.
M1337 The Efficacy of Retrograde Deep Insertion of Single Balloon Endoscopy for Patients with Crohn’s Disease At Times of Conventional Colonoscopy On Outpatients: Prospective, OpenLabel, Feasibility Study Kenji Watanabe, Mitsue Sogawa, Shuhei Hosomi, Kenichi Morimoto, Takehisa Suekane, Noriko Kamata, Natsuhiko Kameda, Hirohisa Machida, Hirotoshi Okazaki, Tetsuya Tanigawa, Hirokazu Yamagami, Kazunari Tominaga, Toshio Watanabe, Yasuhiro Fujiwara, Nobuhide Oshitani, Tetsuo Arakawa Background: The significance of mucosal healing in patients with Crohn’s disease (CD) following treatment with several biologic agents has recieved attention for better patient prognosis recently. But there are some difficulties or problems with endoscopic detection of small bowel CD lesions (e.g. retention, incomplete examination for deep insertion) in spite of the development of capsule endoscopy and double balloon endoscopy. We investigated the efficacy and safety of single balloon endoscopy (SBE) for the purpose of detection of lesions from the upper part to the middle part of ileal and whole colonic lesions at times of conventional colonoscopic examinations on outpatients. Subjects and Methods: We evaluated 25 cases of CD outpatients (L1: 3, L2: 3, L3: 19; 12 cases had history of operations.) who had received retrograde deep insertion of SBE and small bowel barium study (SBBS). We compared both findings prospectively. We scored the findings from the upper part to the middle part of the ileum, the terminal ileum or ileocolonic anastomotic lesions and colonic lesions separately (Gut 2006; 55: 842, altered). Results: The deepest insertion point of SBE was in the upper part of the ileum in 7 cases (28.0%), in the middle part of the ileum in 15 cases (60.0%) and in the lower part of the ileum in 3 cases (12.0%). The average examination time of SBE was 40m01s (24 m 25 s-58 m 18 s) and there were no complications. The examination was performed in 21 cases (84.0%) by two physicians and in 4 cases (16.0%) by one physician. CO2 insufflation was used in 6 cases. Fourteen cases (56.0%) had new CD lesions in the upper or middle part of the ileum compared with observations limited to the terminal ileum and colon. There were more active lesions in 4 cases
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