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Efficacy of a 28-tablet sodium phosphate preparation for colonoscopy
S298
Abstracts
AJG – Vol. 98, No. 9, Suppl., 2003
Results: Of 462 patients screened, 356 subjects were randomized to treatment. Background rate of detectable small bowel lesions in healthy volunteers was 13.8%. Mean number of small bowel mucosal breaks and incidence of subjects with ⱖ1 mucosal break was significantly higher with naproxen⫹omeprazole compared to celecoxib or placebo (Table). Relative risk for small bowel mucosal breaks was 2.23 (95% CI 1.02, 4.88; p⫽0.04) for celecoxib vs placebo; 7.46 (3.81, 14.62; p⬍0.001) for naproxen⫹omeprazole vs placebo; and 3.51 (2.22, 5.53; p⬍0.001) for celecoxib vs naproxen⫹omeprazole.
Mean ⫾SD Incidence n(%)
Celecoxib (nⴝ115)
Naproxenⴙomeprazole (nⴝ111)
Placebo (nⴝ113)
P value*
0.32 ⫾ 1.09 18 (16)
2.97 ⫾ 5.26 61 (55)
0.11 ⫾ 0.45 8 (7)
⬍0.001 ⬍0.001
* Across all groups using Cochran-Mantel Haenszel test stratified by investigator site and treatment
Conclusions: The unexpectedly high baseline rate of muscosal breaks and detectable small bowel lesions in healthy volunteers suggests the need for a placebo arm in future capsule endoscopy trials. The higher incidence of small bowel mucosal injury with naproxen⫹omeprazole compared to celecoxib demonstrates that nonspecific NSAIDs are commonly associated with significantly greater small bowel damage even with a PPI than with celecoxib, a COX-2 specific inhibitor.
894 THE DIAGNOSTIC YIELD OF WIRELESS CAPSULE ENDOSCOPY IN PATIENTS WITH UNEXPLAINED ABDOMINAL PAIN Carl Mele, M.D., Anthony Infantolino, M.D.*, Mitchell Conn, M.D., Thomas Kowalski, M.D., Sidney Cohen, M.D., Anthony DiMarino, M.D. Thomas Jefferson University Hospital, Philadelphia, PA. Purpose: Unexplained abdominal pain is frequently encountered in clinical gastroenterology. The purpose of this study was to evaluate the utility of wireless capsule endoscopy in patients with abdominal pain of unknown etiology. Methods: Twenty patients referred to our center for unexplained abdominal pain underwent capsule endoscopy (CE). They were 18 years of age or older and had normal endoscopic, laboratory, and radiologic evaluation, including small bowel follow-through (SBFT). Patients were excluded if they were pregnant, had suspected small bowel stenosis, a swallowing disorder precluding safe ingestion of the capsule, or major abdominal surgery within the past 12 months. Results: All patients completed the study without any adverse events. The most distal extent of CE images included the colon in 75% of patients (15/20), small bowel in 20% of patients (4/20), and stomach in one patient. Thirty-five percent of patients (7/20) had abnormal transit time, suggesting an abnormality in motility. Five of these patients had delayed gastric emptying (mean 253 min), one had delayed small bowel transit (400 min), and one had rapid small bowel transit (17 min). Thirty percent (6/20) of patients had small bowel mucosal findings on CE that were not seen on SBFT. Four of these six patients had erythematous lesions, one patient had non-bleeding vascular ectasias, and one patient had both erythematous lesions and vascular ectasias. A total of nine patients (45%) had abnormal transit, mucosal findings, or both. Conclusions: In patients with unexplained abdominal pain, CE can provide information about the small bowel that may not have been found with conventional SBFT. Suggestive findings were discovered in 45% of patients, including gastrointestinal transit disorders and small bowel erythematous lesions. The latter group may represent occult small bowel Crohn’s disease. The present battery life of up to 8 hours may be inadequate in evaluating this subset of patients with unexplained abdominal pain and disorders of bowel transit.
895 EFFICACY OF A 28-TABLET SODIUM PHOSPHATE PREPARATION FOR COLONOSCOPY Kiran J. Kanji, M.D., Michael D. Brown, M.D.* Rush Presbyterian St. Luke’s Medical Center, Chicago, IL. Purpose: For many patients the difficulty of completing large volume bowel preparations is a deterrent to screening colonoscopy. Despite this over 80% of the preparations for colonoscopy in the U.S. involve the use of 4L polyethylene glycol (PEG). We have previously reported that 94% of patients would prefer to have a choice of preparation and 61% felt that providing different options for preparations might influence their choice of gastroenterologist. Of the patients who had taken the 4L PEG preparation only 12% would choose this preparation again compared to 66% of patients who took a 40 tablet NaP tablets. Our aim was to evaluate the efficacy of a potentially even more palatable 24 tablet NaP prep to 4L PEG solution and NaP liquid preparations. Methods: We retrospectively evaluated 886 outpatient colonoscopies between March 2002 and March 2003. Data was tabulated after examining endoscopic reports. A single endoscopist assessed preparation quality as adequate, excellent, good, fair, and poor. All poor preps resulted in an incomplete procedure requiring rescheduling or abandonment. Since April 2003 we have also prospectively evaluated the prep quality of 58 outpatient colonoscopies. Results: Of the 886 retrospectively evaluated procedures, 563 (63.5%) took the NaP 28 tablet prep, 287 (32.4%) took the 4L PEG solution, and 36 (4%) took the NaP liquid prep. 10 (1.13%) procedures were determined to be poor or unacceptable. Of these, significantly fewer patients (1 ⫽ 0.17%) had taken the NaP preparations compared to the 4L PEG (9 ⫽ 3%) (p ⬍ 0.05). Of the 58 procedures evaluated prospectively, 22 (37.9%) took the NaP 28 tablet prep, 30 (51.7%) took the 4L PEG solution, and 6 (10.34%) took the NaP liquid prep. Only 3 (5%) procedures were of poor quality, of which all were the 4L PEG solution. Prep Data Prep Type NaP tablet PEG NaP liquid Totals % of Totals
Adequate Excellent Good Fair Poor Totals % of Totals 213 121 19 353 39.8
525 98 11 361 40.7
87 43 5 135 15.2
10 16 1 27 3.1
1 9 0 10 1.1
563 287 36 886
63.5 32.4 4.1
Conclusions: A reduced tablet regimen of 28 tablets of NaP was associated with significantly fewer failed preparations than PEG solution when used for routine colonoscopy lavage. Ease of adminstration and adherence to the dosing protocol may be some of the reasons for this observed difference. 896 ENDOSCOPIC RESECTION OF A LARGE DUODENAL ADENOMA WITH BANDING DEVICE AND SNARE POLYPECTOMY IN A PATIENT WITH FAP Dawn D. Ferguson, M.D., Timothy A. Woodward, M.D.*, David S. Loeb, M.D. Mayo Clinic, Jacksonville, FL. A 53 year-old female patient with an extensive family and personal history of familial adenomatous polyposis (FAP) presented for evaluation and treatment of a large duodenal polyp visualized on recent screening upper endoscopy. The patient was advised to have the polyp surgically removed because of the risk of progression to carcinoma but was reluctant to pursue surgical resection. On upper endoscopy, a 3 cm sessile polyp was visualized opposite to the Ampulla of Vater. Epinephrine 1:10,000 solution was injected at the base to separate the mucosa from the submucosa. A total of 10 cc was used. A pre-fitted banding device was then used to place two bands over the tented mucosa. A standard endoscope was re-inserted and a snare device was used to retrieve the banded areas. Areas not encompassed by the bands were excised with cold biopsy forceps in a piece-meal
Abstracts
AJG – Vol. 98, No. 9, Suppl., 2003
Results: Of 462 patients screened, 356 subjects were randomized to treatment. Background rate of detectable small bowel lesions in healthy volunteers was 13.8%. Mean number of small bowel mucosal breaks and incidence of subjects with ⱖ1 mucosal break was significantly higher with naproxen⫹omeprazole compared to celecoxib or placebo (Table). Relative risk for small bowel mucosal breaks was 2.23 (95% CI 1.02, 4.88; p⫽0.04) for celecoxib vs placebo; 7.46 (3.81, 14.62; p⬍0.001) for naproxen⫹omeprazole vs placebo; and 3.51 (2.22, 5.53; p⬍0.001) for celecoxib vs naproxen⫹omeprazole.
Mean ⫾SD Incidence n(%)
Celecoxib (nⴝ115)
Naproxenⴙomeprazole (nⴝ111)
Placebo (nⴝ113)
P value*
0.32 ⫾ 1.09 18 (16)
2.97 ⫾ 5.26 61 (55)
0.11 ⫾ 0.45 8 (7)
⬍0.001 ⬍0.001
* Across all groups using Cochran-Mantel Haenszel test stratified by investigator site and treatment
Conclusions: The unexpectedly high baseline rate of muscosal breaks and detectable small bowel lesions in healthy volunteers suggests the need for a placebo arm in future capsule endoscopy trials. The higher incidence of small bowel mucosal injury with naproxen⫹omeprazole compared to celecoxib demonstrates that nonspecific NSAIDs are commonly associated with significantly greater small bowel damage even with a PPI than with celecoxib, a COX-2 specific inhibitor.
894 THE DIAGNOSTIC YIELD OF WIRELESS CAPSULE ENDOSCOPY IN PATIENTS WITH UNEXPLAINED ABDOMINAL PAIN Carl Mele, M.D., Anthony Infantolino, M.D.*, Mitchell Conn, M.D., Thomas Kowalski, M.D., Sidney Cohen, M.D., Anthony DiMarino, M.D. Thomas Jefferson University Hospital, Philadelphia, PA. Purpose: Unexplained abdominal pain is frequently encountered in clinical gastroenterology. The purpose of this study was to evaluate the utility of wireless capsule endoscopy in patients with abdominal pain of unknown etiology. Methods: Twenty patients referred to our center for unexplained abdominal pain underwent capsule endoscopy (CE). They were 18 years of age or older and had normal endoscopic, laboratory, and radiologic evaluation, including small bowel follow-through (SBFT). Patients were excluded if they were pregnant, had suspected small bowel stenosis, a swallowing disorder precluding safe ingestion of the capsule, or major abdominal surgery within the past 12 months. Results: All patients completed the study without any adverse events. The most distal extent of CE images included the colon in 75% of patients (15/20), small bowel in 20% of patients (4/20), and stomach in one patient. Thirty-five percent of patients (7/20) had abnormal transit time, suggesting an abnormality in motility. Five of these patients had delayed gastric emptying (mean 253 min), one had delayed small bowel transit (400 min), and one had rapid small bowel transit (17 min). Thirty percent (6/20) of patients had small bowel mucosal findings on CE that were not seen on SBFT. Four of these six patients had erythematous lesions, one patient had non-bleeding vascular ectasias, and one patient had both erythematous lesions and vascular ectasias. A total of nine patients (45%) had abnormal transit, mucosal findings, or both. Conclusions: In patients with unexplained abdominal pain, CE can provide information about the small bowel that may not have been found with conventional SBFT. Suggestive findings were discovered in 45% of patients, including gastrointestinal transit disorders and small bowel erythematous lesions. The latter group may represent occult small bowel Crohn’s disease. The present battery life of up to 8 hours may be inadequate in evaluating this subset of patients with unexplained abdominal pain and disorders of bowel transit.
895 EFFICACY OF A 28-TABLET SODIUM PHOSPHATE PREPARATION FOR COLONOSCOPY Kiran J. Kanji, M.D., Michael D. Brown, M.D.* Rush Presbyterian St. Luke’s Medical Center, Chicago, IL. Purpose: For many patients the difficulty of completing large volume bowel preparations is a deterrent to screening colonoscopy. Despite this over 80% of the preparations for colonoscopy in the U.S. involve the use of 4L polyethylene glycol (PEG). We have previously reported that 94% of patients would prefer to have a choice of preparation and 61% felt that providing different options for preparations might influence their choice of gastroenterologist. Of the patients who had taken the 4L PEG preparation only 12% would choose this preparation again compared to 66% of patients who took a 40 tablet NaP tablets. Our aim was to evaluate the efficacy of a potentially even more palatable 24 tablet NaP prep to 4L PEG solution and NaP liquid preparations. Methods: We retrospectively evaluated 886 outpatient colonoscopies between March 2002 and March 2003. Data was tabulated after examining endoscopic reports. A single endoscopist assessed preparation quality as adequate, excellent, good, fair, and poor. All poor preps resulted in an incomplete procedure requiring rescheduling or abandonment. Since April 2003 we have also prospectively evaluated the prep quality of 58 outpatient colonoscopies. Results: Of the 886 retrospectively evaluated procedures, 563 (63.5%) took the NaP 28 tablet prep, 287 (32.4%) took the 4L PEG solution, and 36 (4%) took the NaP liquid prep. 10 (1.13%) procedures were determined to be poor or unacceptable. Of these, significantly fewer patients (1 ⫽ 0.17%) had taken the NaP preparations compared to the 4L PEG (9 ⫽ 3%) (p ⬍ 0.05). Of the 58 procedures evaluated prospectively, 22 (37.9%) took the NaP 28 tablet prep, 30 (51.7%) took the 4L PEG solution, and 6 (10.34%) took the NaP liquid prep. Only 3 (5%) procedures were of poor quality, of which all were the 4L PEG solution. Prep Data Prep Type NaP tablet PEG NaP liquid Totals % of Totals
Adequate Excellent Good Fair Poor Totals % of Totals 213 121 19 353 39.8
525 98 11 361 40.7
87 43 5 135 15.2
10 16 1 27 3.1
1 9 0 10 1.1
563 287 36 886
63.5 32.4 4.1
Conclusions: A reduced tablet regimen of 28 tablets of NaP was associated with significantly fewer failed preparations than PEG solution when used for routine colonoscopy lavage. Ease of adminstration and adherence to the dosing protocol may be some of the reasons for this observed difference. 896 ENDOSCOPIC RESECTION OF A LARGE DUODENAL ADENOMA WITH BANDING DEVICE AND SNARE POLYPECTOMY IN A PATIENT WITH FAP Dawn D. Ferguson, M.D., Timothy A. Woodward, M.D.*, David S. Loeb, M.D. Mayo Clinic, Jacksonville, FL. A 53 year-old female patient with an extensive family and personal history of familial adenomatous polyposis (FAP) presented for evaluation and treatment of a large duodenal polyp visualized on recent screening upper endoscopy. The patient was advised to have the polyp surgically removed because of the risk of progression to carcinoma but was reluctant to pursue surgical resection. On upper endoscopy, a 3 cm sessile polyp was visualized opposite to the Ampulla of Vater. Epinephrine 1:10,000 solution was injected at the base to separate the mucosa from the submucosa. A total of 10 cc was used. A pre-fitted banding device was then used to place two bands over the tented mucosa. A standard endoscope was re-inserted and a snare device was used to retrieve the banded areas. Areas not encompassed by the bands were excised with cold biopsy forceps in a piece-meal