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Risk of Immediate and Delayed Complications with Percutaneous Gastrostomy and Jejunostomy Tubes in Patients Receiving Bevacizumab
Abstracts
325 The Clinical Value of the Duodenal Biopsy: A Nation-Wide Clinicopathologic Analysis of 20,000 Patients Susanne W. Carmack, Robert M. Genta Purpose: Duodenal biopsies are routinely obtained from patients undergoing EGD for the investigation of iron-deficiency anemia, shown in prospective studies to be associated with celiac sprue in ~3% of patients. The yield of these biopsies in clinical practice is unknown. Using a nation-wide sample of patients, we assessed the value of duodenal biopsies in relation to the indications for EGD. Methods: We analyzed data from Caris Diagnostics, a specialized gastrointestinal pathology group receiving specimens from endoscopy centers in 40 states; biopsy interpretation is maintained uniform through standardized procedures, diagnostic criteria, and terminology. The database includes demographic, clinical, and endoscopic information, site of origin, and histopathologic report for each biopsy. We extracted data from all patients who underwent EGD with gastric and duodenal biopsies from 4/07 to 3/08. Statistics were performed using SigmaStat 3.5; odd ratios were calculated using Hutchon’s online calculator. A p value !0.05 was considered significant. Results: Duodenal biopsies were available from 20,461 unique patients (66% women; median age 52 years, range 0-92). Anemia was the main EGD indication in 3,079 patients; dyspepsia in 8,941; GERD in 5,970; and ‘‘rule out sprue’’ in 511. Irrespective of the indication, O 82% of duodenal biopsies were normal, except when sprue was suspected (71%, OR 1.98, 95% CI 1.63-21). Flattened mucosa consistent with sprue (Marsh 3b-3c) was seen in 0.9% of all patients, in 1.4% of those with anemia (OR 1.63, 95% CI 1.17-2.28); and in 10.8% of patients with suspected sprue (OR 13.9, 95% CI 10.1-19.0; p!0.001). Variable villous atrophy (Marsh 2-3a) was 10 times as common in patients with suspected sprue than in all other patients (7.8% vs. 0.8%; OR 9.76, 95% CI 6.84-13.94). Intraepithelial lymphocytosis (Marsh 1) was almost twice as common in patients with suspected sprue (7.4% vs. 4.1%) than in all others (OR 1.85, 95% CI 1.32-2.60; p!0.01). Marsh 1, 2, and 3a lesions were not more frequent in patients with anemia. Peptic duodenopathy was unrelated to the EGD indication. Conclusion: In this population duodenal biopsies were highly valuable in patients with suspected (or serologically documented) celiac sprue. Patients investigated for anemia had a slight but significantly greater prevalence of Marsh 3b and 3c lesions than patients who had EGD for other indications. This suggests that, perhaps combined with serologic tests, duodenal biopsies may have a role in the evaluation of anemia. In patients with other indications and no endoscopic abnormalities 5% to 10% of duodenal biopsies yielded clinically useful results.
326 A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine As Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP): Interim Analysis Results Swapna B. Reddy, Kenneth J. Chang, John G. Lee, Thomas T. Nguyen, Christopher E. Lee, Charles Whang, Makoto Nishimura, Susumu Shinoura, Reiko Ashida, Raman Muthusamy Introduction: Due to their prolonged procedure durations, sedation with meperidine (Me) and midazolam (Mz) for EUS and ERCP is often inadequate. Given the cardiac risks of droperidol and the frequent usage restrictions on propofol, alternative adjunct sedatives for such procedures are needed. We aimed to determine if diphenhydramine(D) or promethazine(P) would improve sedation quality during EUS and ERCP. Methods: All patients 18-75 years old presenting to our center for upper EUS and ERCP procedures were asked to participate. After obtaining IRB-approved consent, patients were randomized to receive one of three identically appearing injectable agents: placebo (normal saline, NS), P, or D. During the procedure, each group received standard doses of Me and Mz along with NS, P, or D. The primary outcome was the sedation failure rate for each drug. Secondary outcomes included time needed to achieve adequate sedation, Me and Mz doses used (mg), procedure recovery time (minutes), adverse events, pain and nausea scores, physician/nurse/patient satisfaction scores, and post-procedure recall. Results: To date, 175 (D-57, P-60, NS-58) of a target 465 patients have been enrolled. Subjects had a mean age of 57; 51% women. The groups were similar in all measured baseline characteristics except for an percentage of women in the NS group (pZ0.047). EUS comprised 83% of procedures. A trend toward a reduced number of sedation failures (NZ18; P-5%, D-13%, NS-14%, pZ0.25; P vs NS pZ.106; P vs D, pZ.167; D vs NS, pZ.810) was seen with P compared to D or NS. No difference was noted in the time needed to achieve sedation (pZ0.43). Patients receiving NS required significantly greater Me (P-120.6, D-123.6, NS-145.9; pZ0.001) and Mz (P-5.4, D-5.6, NS-6.4; pZ0.004) compared to patients receiving P or D.Longer procedure recovery times were seen in the P group(P-51.5, D-29.5, NS-21.3; p!0.0001). No differences in adverse outcomes, pain, nausea, or patient/ nurse/ physician satisfaction scores were seen between the groups. Post-procedure, patients had recall of intra-procedure events significantly less often when receiving D (5% vs 12.9%, pZ0.0479) or P (1.0% vs 12.9%, pZ0.0007) compared to NS. However, this difference did not persist at 24 hours. Conclusions: A strong trend toward reduced sedation failures and a significant increase in recovery times was seen with P compared to D or placebo in this ongoing study of patients receiving EUS and ERCP. D and P were associated with statistically significant, but clinically insignificant, reductions in Me and Mz usage. The groups were similar regarding adverse events, nausea, pain, and physician/nurse/patient satisfaction scores.
AB104 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
327 A Comparison of Split Dose Polyethylene Glycol-Electrolyte Solution D Simethicone Versus Standard Overnight Fast for Small Bowel Cleansing Prior to Capsule Endoscopy (CE) Bridget J. Seymour, Rebecca Matro, Constantine Daskalakis, Neilanjan Nandi, David M. Kastenberg Background: CE requires adequate small bowel (SB) visibility. The standard CE prep (‘‘standard prep’’), clears after 12pm and NPO after 10pm the day prior, is often inadequate. Polyethylene glycol-electrolyte solution (PEG) and simethicone may each enhance visualization. Past studies to optimize SB cleansing have relied on non-validated SB grading scales. Aim: To evaluate the efficacy of PEG combined with simethicone (‘‘PEG-S’’) to cleanse the SB for CE. Methods: A retrospective chart review of 59 consecutive outpts (4/07-11/08) who received PEG-S for CE. The Control group was 40 CE pts (6/05-5/06) who received the standard prep and were previously graded for prep quality as part of a validation study. PEG (MoviPrepÒ) 1L þ simethicone (PhazymeÒ) 180 mg was taken at 18: 00 the day prior and repeated 3 hrs before CE. Both groups followed the standard prep diet. All CE preps were graded by one investigator (DK) using 3 previously validated scales demonstrating a strong and highly significant association between them all: 1.Quantitative Index(QI): 5 elements (mucosal visualization, fluid/debris, bubbles, bile/chyme staining, brightness), total score 0-10, higher Z superior cleansing, 2.Qualitative Evaluation(QE): Excellent, good, fair, or poor, 3.Overall Adequacy Assessment(OAA): Adequate or inadequate. Prep was considered satisfactory when QI O7, QE good or excellent, or OAA adequate. Scoring discrepancies were resolved using the majority of scores for the 3 scales. Results: The PEG-S group mean age was 47(18-83) and 64% were female. PEG-S and Control groups were well matched for age, gender, weight, and medications. More pts receiving PEG-S had a CE indication of GI bleed. Controls were all scored with 3 scales, and 2/40 had score discrepancies - one resolved as satisfactory, the other as unsatisfactory. For the PEG-S group, 21 were scored with 2 scales (13 QI and QE, 8 QI and OAA) and 38 with 1 scale (13 QI, 17 QE, 8 OAA); there were no score discrepancies. Satisfactory SB cleansing was achieved significantly more often with PEG-S compared to Controls (90% vs. 65%) (OR 4.68; 95% CI 1.48-16.6; pZ0.004). The likelihood of satisfactory cleansing with PEG-S was greater on multivariate analysis (OR 6.27; 95% CI 1.87-24.09; pZ0.001). The mean QI score was significantly higher with PEG-S (9.0 þ/- 1.2 vs. 8.1 þ/- 1.7; pZ0.024). Neither age nor gender predicted prep quality, but an indication of abdominal pain did predict better cleansing (OR 4.29, 95 CI 1.10-21.50; pZ0.029). The frequency of any finding on CE did not differ between the two study groups. Conclusion: PEG-S is superior to an overnight fast alone in achieving satisfactory visualization of the SB for CE.
328 Risk of Immediate and Delayed Complications with Percutaneous Gastrostomy and Jejunostomy Tubes in Patients Receiving Bevacizumab Anjani Jammula, Mark A. Schattner, Moshe Shike Background: Bevacizumab is a humanized monoclonal antibody targeting the vascular endothelial growth factor. Although, it is generally well tolerated, gastrointestinal (GI) complications include perforation and bleeding. There is no data on the safety of performing a percutaneous endoscopic gastrostomy (PEG) or jejunostomy (PEJ) in patients receiving Bevacizumab. Objective: To determine the risk of immediate and delayed GI perforation and bleeding following PEG and PEJ tube placement in patients who received Bevacizumab within 60 days of the procedure. Methods: A retrospective chart review of all patients who underwent a successful PEG or PEJ between January 2003 and August 2008, and also received Bevacizumab within 60 days of the procedure was done. Data included demographics, type of cancer, prior treatment, indication for PEG/PEJ, timing of Bevacizumab and post-procedural complications. Results: 83 patients were identified. Underlying cancers included: head & neck (35), colorectal (19), ovarian (11), other GI (13) and others (5). Forty six (55%) were men and 37 (45%) were women. The mean age was 55 years (range, 21-80). Forty three (52%) underwent a major abdominal surgery prior to the procedure and the primary tumor was resected in 46 (55%) of them. There were 77 (92%) gastrostomies and 6 (8%) jejunostomies. The indication was enteral feeding in 46 (55%) and GI decompression in 37 (45%). Thirty nine had their procedure 13.6 þ/- 12 days before starting Bevacizumab, 41 had their PEG/PEJ placed 31 þ/- 30 days after stopping Bevacizumab and 4 while receiving Bevacizumab. There were 6 complications, 3 major and 3 minor: GI bleeding requiring transfusion (2), pneumatosis intestinalis and sepsis (1), abdominal pain (2), and a buried bumper (1). The bleeding was 105 and 30 days post procedure and Bevacizumab discontinuation respectively in the first patient and 15 and 60 days in the second patient. Neither was a procedure related complication nor was the PEG site a source of bleeding. One was bleeding from tumor and the other from hemobilia. One patient developed pneumatosis of the GI tract, along with air in the portal venous system, 2 and 17 days after PEJ placement and stopping Bevacizumab respectively. This was the only major procedure related complication and the patient improved with antibiotics and observation. Of the 3 minor, 2 had persistent abdominal pain that resolved spontaneously and 1 was a buried bumper that required PEG revision. Conclusion: Placement of PEG or PEJ tubes in patients receiving Bevacizumab within 60 days of the procedure is safe. Also, use of Bevacizumab is safe in patients who underwent a recent gastrostomy or jejunostomy.
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325 The Clinical Value of the Duodenal Biopsy: A Nation-Wide Clinicopathologic Analysis of 20,000 Patients Susanne W. Carmack, Robert M. Genta Purpose: Duodenal biopsies are routinely obtained from patients undergoing EGD for the investigation of iron-deficiency anemia, shown in prospective studies to be associated with celiac sprue in ~3% of patients. The yield of these biopsies in clinical practice is unknown. Using a nation-wide sample of patients, we assessed the value of duodenal biopsies in relation to the indications for EGD. Methods: We analyzed data from Caris Diagnostics, a specialized gastrointestinal pathology group receiving specimens from endoscopy centers in 40 states; biopsy interpretation is maintained uniform through standardized procedures, diagnostic criteria, and terminology. The database includes demographic, clinical, and endoscopic information, site of origin, and histopathologic report for each biopsy. We extracted data from all patients who underwent EGD with gastric and duodenal biopsies from 4/07 to 3/08. Statistics were performed using SigmaStat 3.5; odd ratios were calculated using Hutchon’s online calculator. A p value !0.05 was considered significant. Results: Duodenal biopsies were available from 20,461 unique patients (66% women; median age 52 years, range 0-92). Anemia was the main EGD indication in 3,079 patients; dyspepsia in 8,941; GERD in 5,970; and ‘‘rule out sprue’’ in 511. Irrespective of the indication, O 82% of duodenal biopsies were normal, except when sprue was suspected (71%, OR 1.98, 95% CI 1.63-21). Flattened mucosa consistent with sprue (Marsh 3b-3c) was seen in 0.9% of all patients, in 1.4% of those with anemia (OR 1.63, 95% CI 1.17-2.28); and in 10.8% of patients with suspected sprue (OR 13.9, 95% CI 10.1-19.0; p!0.001). Variable villous atrophy (Marsh 2-3a) was 10 times as common in patients with suspected sprue than in all other patients (7.8% vs. 0.8%; OR 9.76, 95% CI 6.84-13.94). Intraepithelial lymphocytosis (Marsh 1) was almost twice as common in patients with suspected sprue (7.4% vs. 4.1%) than in all others (OR 1.85, 95% CI 1.32-2.60; p!0.01). Marsh 1, 2, and 3a lesions were not more frequent in patients with anemia. Peptic duodenopathy was unrelated to the EGD indication. Conclusion: In this population duodenal biopsies were highly valuable in patients with suspected (or serologically documented) celiac sprue. Patients investigated for anemia had a slight but significantly greater prevalence of Marsh 3b and 3c lesions than patients who had EGD for other indications. This suggests that, perhaps combined with serologic tests, duodenal biopsies may have a role in the evaluation of anemia. In patients with other indications and no endoscopic abnormalities 5% to 10% of duodenal biopsies yielded clinically useful results.
326 A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine As Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP): Interim Analysis Results Swapna B. Reddy, Kenneth J. Chang, John G. Lee, Thomas T. Nguyen, Christopher E. Lee, Charles Whang, Makoto Nishimura, Susumu Shinoura, Reiko Ashida, Raman Muthusamy Introduction: Due to their prolonged procedure durations, sedation with meperidine (Me) and midazolam (Mz) for EUS and ERCP is often inadequate. Given the cardiac risks of droperidol and the frequent usage restrictions on propofol, alternative adjunct sedatives for such procedures are needed. We aimed to determine if diphenhydramine(D) or promethazine(P) would improve sedation quality during EUS and ERCP. Methods: All patients 18-75 years old presenting to our center for upper EUS and ERCP procedures were asked to participate. After obtaining IRB-approved consent, patients were randomized to receive one of three identically appearing injectable agents: placebo (normal saline, NS), P, or D. During the procedure, each group received standard doses of Me and Mz along with NS, P, or D. The primary outcome was the sedation failure rate for each drug. Secondary outcomes included time needed to achieve adequate sedation, Me and Mz doses used (mg), procedure recovery time (minutes), adverse events, pain and nausea scores, physician/nurse/patient satisfaction scores, and post-procedure recall. Results: To date, 175 (D-57, P-60, NS-58) of a target 465 patients have been enrolled. Subjects had a mean age of 57; 51% women. The groups were similar in all measured baseline characteristics except for an percentage of women in the NS group (pZ0.047). EUS comprised 83% of procedures. A trend toward a reduced number of sedation failures (NZ18; P-5%, D-13%, NS-14%, pZ0.25; P vs NS pZ.106; P vs D, pZ.167; D vs NS, pZ.810) was seen with P compared to D or NS. No difference was noted in the time needed to achieve sedation (pZ0.43). Patients receiving NS required significantly greater Me (P-120.6, D-123.6, NS-145.9; pZ0.001) and Mz (P-5.4, D-5.6, NS-6.4; pZ0.004) compared to patients receiving P or D.Longer procedure recovery times were seen in the P group(P-51.5, D-29.5, NS-21.3; p!0.0001). No differences in adverse outcomes, pain, nausea, or patient/ nurse/ physician satisfaction scores were seen between the groups. Post-procedure, patients had recall of intra-procedure events significantly less often when receiving D (5% vs 12.9%, pZ0.0479) or P (1.0% vs 12.9%, pZ0.0007) compared to NS. However, this difference did not persist at 24 hours. Conclusions: A strong trend toward reduced sedation failures and a significant increase in recovery times was seen with P compared to D or placebo in this ongoing study of patients receiving EUS and ERCP. D and P were associated with statistically significant, but clinically insignificant, reductions in Me and Mz usage. The groups were similar regarding adverse events, nausea, pain, and physician/nurse/patient satisfaction scores.
AB104 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
327 A Comparison of Split Dose Polyethylene Glycol-Electrolyte Solution D Simethicone Versus Standard Overnight Fast for Small Bowel Cleansing Prior to Capsule Endoscopy (CE) Bridget J. Seymour, Rebecca Matro, Constantine Daskalakis, Neilanjan Nandi, David M. Kastenberg Background: CE requires adequate small bowel (SB) visibility. The standard CE prep (‘‘standard prep’’), clears after 12pm and NPO after 10pm the day prior, is often inadequate. Polyethylene glycol-electrolyte solution (PEG) and simethicone may each enhance visualization. Past studies to optimize SB cleansing have relied on non-validated SB grading scales. Aim: To evaluate the efficacy of PEG combined with simethicone (‘‘PEG-S’’) to cleanse the SB for CE. Methods: A retrospective chart review of 59 consecutive outpts (4/07-11/08) who received PEG-S for CE. The Control group was 40 CE pts (6/05-5/06) who received the standard prep and were previously graded for prep quality as part of a validation study. PEG (MoviPrepÒ) 1L þ simethicone (PhazymeÒ) 180 mg was taken at 18: 00 the day prior and repeated 3 hrs before CE. Both groups followed the standard prep diet. All CE preps were graded by one investigator (DK) using 3 previously validated scales demonstrating a strong and highly significant association between them all: 1.Quantitative Index(QI): 5 elements (mucosal visualization, fluid/debris, bubbles, bile/chyme staining, brightness), total score 0-10, higher Z superior cleansing, 2.Qualitative Evaluation(QE): Excellent, good, fair, or poor, 3.Overall Adequacy Assessment(OAA): Adequate or inadequate. Prep was considered satisfactory when QI O7, QE good or excellent, or OAA adequate. Scoring discrepancies were resolved using the majority of scores for the 3 scales. Results: The PEG-S group mean age was 47(18-83) and 64% were female. PEG-S and Control groups were well matched for age, gender, weight, and medications. More pts receiving PEG-S had a CE indication of GI bleed. Controls were all scored with 3 scales, and 2/40 had score discrepancies - one resolved as satisfactory, the other as unsatisfactory. For the PEG-S group, 21 were scored with 2 scales (13 QI and QE, 8 QI and OAA) and 38 with 1 scale (13 QI, 17 QE, 8 OAA); there were no score discrepancies. Satisfactory SB cleansing was achieved significantly more often with PEG-S compared to Controls (90% vs. 65%) (OR 4.68; 95% CI 1.48-16.6; pZ0.004). The likelihood of satisfactory cleansing with PEG-S was greater on multivariate analysis (OR 6.27; 95% CI 1.87-24.09; pZ0.001). The mean QI score was significantly higher with PEG-S (9.0 þ/- 1.2 vs. 8.1 þ/- 1.7; pZ0.024). Neither age nor gender predicted prep quality, but an indication of abdominal pain did predict better cleansing (OR 4.29, 95 CI 1.10-21.50; pZ0.029). The frequency of any finding on CE did not differ between the two study groups. Conclusion: PEG-S is superior to an overnight fast alone in achieving satisfactory visualization of the SB for CE.
328 Risk of Immediate and Delayed Complications with Percutaneous Gastrostomy and Jejunostomy Tubes in Patients Receiving Bevacizumab Anjani Jammula, Mark A. Schattner, Moshe Shike Background: Bevacizumab is a humanized monoclonal antibody targeting the vascular endothelial growth factor. Although, it is generally well tolerated, gastrointestinal (GI) complications include perforation and bleeding. There is no data on the safety of performing a percutaneous endoscopic gastrostomy (PEG) or jejunostomy (PEJ) in patients receiving Bevacizumab. Objective: To determine the risk of immediate and delayed GI perforation and bleeding following PEG and PEJ tube placement in patients who received Bevacizumab within 60 days of the procedure. Methods: A retrospective chart review of all patients who underwent a successful PEG or PEJ between January 2003 and August 2008, and also received Bevacizumab within 60 days of the procedure was done. Data included demographics, type of cancer, prior treatment, indication for PEG/PEJ, timing of Bevacizumab and post-procedural complications. Results: 83 patients were identified. Underlying cancers included: head & neck (35), colorectal (19), ovarian (11), other GI (13) and others (5). Forty six (55%) were men and 37 (45%) were women. The mean age was 55 years (range, 21-80). Forty three (52%) underwent a major abdominal surgery prior to the procedure and the primary tumor was resected in 46 (55%) of them. There were 77 (92%) gastrostomies and 6 (8%) jejunostomies. The indication was enteral feeding in 46 (55%) and GI decompression in 37 (45%). Thirty nine had their procedure 13.6 þ/- 12 days before starting Bevacizumab, 41 had their PEG/PEJ placed 31 þ/- 30 days after stopping Bevacizumab and 4 while receiving Bevacizumab. There were 6 complications, 3 major and 3 minor: GI bleeding requiring transfusion (2), pneumatosis intestinalis and sepsis (1), abdominal pain (2), and a buried bumper (1). The bleeding was 105 and 30 days post procedure and Bevacizumab discontinuation respectively in the first patient and 15 and 60 days in the second patient. Neither was a procedure related complication nor was the PEG site a source of bleeding. One was bleeding from tumor and the other from hemobilia. One patient developed pneumatosis of the GI tract, along with air in the portal venous system, 2 and 17 days after PEJ placement and stopping Bevacizumab respectively. This was the only major procedure related complication and the patient improved with antibiotics and observation. Of the 3 minor, 2 had persistent abdominal pain that resolved spontaneously and 1 was a buried bumper that required PEG revision. Conclusion: Placement of PEG or PEJ tubes in patients receiving Bevacizumab within 60 days of the procedure is safe. Also, use of Bevacizumab is safe in patients who underwent a recent gastrostomy or jejunostomy.
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