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The correlation of acid reflux symptoms with ambulatory pH monitoring: a retrospective analysis
AJG – September, Suppl., 2003
82 THE CORRELATION OF ACID REFLUX SYMPTOMS WITH AMBULATORY PH MONITORING: A RETROSPECTIVE ANALYSIS Marc R. Happe D.O., Andrew C. Gorske, M.D., Corinne L. Maydonovitch, B.S., Lavern S. Belle, B.S., Roy K.H. Wong, M.D.*. Walter Reed Army Medical Center, Washington, DC and Darnall Army Community Hospital, Fort Hood, TX. Purpose: Despite the growing use and number of GERD symptom questionnaires, limited data exists correlating reflux symptoms to the results of diagnostic tests. This study examined the association of reflux symptoms in relation to objective measures of acid reflux by pH monitoring in a cohort of patients presenting for esophageal motility and pH testing. Methods: 537 charts from patients undergoing esophageal motility/pH testing at the Walter Reed Army Medical Center from 1997 and 1998 were reviewed. Prior to manometry, patients completed a questionnaire concerning the presence of GERD symptoms, smoking history, and body position while sleeping. Exclusion criteria included: testing on acid suppression medications, achalasia, nutcracker esophagus, hypertensive LESp, previous anti-reflux surgery or incomplete data. 220 charts met inclusion criteria (M:F 145:75; Mean age⫾ SD: 42⫾14 yrs). A 24-hour Johnson/DeMeester (J/D) score ⬎ 20 was considered abnormal. Results: 87% (189/218) of patients reported heartburn. Of all GERD symptoms assessed (heartburn, chest pain, dysphagia, regurgitation, sour taste, and belching), only heartburn was an independent predictor of an abnormal 24-hour pH score (p⫽0.015). Heartburn ⫹ (HB⫹) patients had significantly more reflux [% total time pH ⬍ 4 (p⫽0.048) and a higher J/D score (p⫽0.050)] than patients without heartburn. HB⫹ patients were 2.72 times (95% CI, 1.2– 6.1) more likely to have an abnormal 24-hour pH score. When further evaluating four specific heartburn descriptors (pressure, sharp pain, constant burning, or ascending burning sensation), no significant differences were noted in reflux parameters or LESp. Patients with nocturnal heartburn (HBn ⫹) had significantly higher J/D scores (43 vs. 29), % total (8.2% vs. 5.5%), % upright (9.0% vs. 6.3%), and % supine reflux (6.5% vs. 3.8%) compared to HBn ⫺ patients (p⬍0.05). Interestingly, there was no significant difference between sleeping position (left, right, back, stomach, no preference) and abnormal pH score. Smokers (past or current), however, were 2.22 times (95% CI, 1.2– 4.1) more likely to have an abnormal pH score as compared to non-smokers (p⫽0.024). Conclusions: (1) These data support existing literature that the symptom of heartburn is the single best predictor of acid reflux. (2) Patients with nocturnal heartburn and smokers have the worst reflux. Aggressive GERD treatment and surveillance may be warranted in these patients. 83 CAN ENDOSCOPIC MUCOSAL RESECTION COMPLETELY REMOVE CANCER OR DYSPLASIA IN BARRETTS ESOPHAGUS? Kenneth K. Wang, M.D.*, Lori Lutzke, Navtej S. Buttar, M.D., Michel WongKeeSong, M.D., Sarah Wandersee. Mayo Clinic, Rochester, MN. Purpose: Endoscopic mucosal resection (EMR) has been used to treat early cancers and dysplasia within Barrett’s esophagus. We reviewed our experience with this technique between 1990 –2003. Aim: To determine the ability of EMR to completely resect lesions within Barrett’s esophagus. Methods: All patients seen in the Barrett’s Esophagus Unit were eligible for entry. Patients with suspected cancers or high grade dysplasia were initially evaluated with EUS to determine if invasion or metastasis occurred. Patients had EMR performed by two different techniques. All were initially injected with 5–20 ml of diluted epinephrine. After the lesion was lifted, a pseudopolyp was created by use of an endoscopic variceal ligating device between 1990 –2000. This BAND technique was completed by using a small snare to remove the lesion. After 4/2000, we used a CAP technique which allowed the tissue to be suctioned into a EMR cap that had
Abstracts
S29
a pre-formed snare positioned at the distal lip of the cap. Tissue was examined by experienced gastrointestinal pathologist. All procedures were performed by a single experienced endoscopist. Results: 171 patients aged 66⫾1 years with biopsy proven Barrett’s esophagus (140 males and 31 females) were treated with EMR. These patients had a mean Barrett’s length of 5 centimeters. These patients had 228 (range 1–5) mucosal resections performed on 92 (40%) solitary nodules, 77 (34%) areas of nodularity, 32 (14%) areas of mucosal irregularity, and 27 miscellaneous other lesions. The initial diagnosis was cancer in 71 (31%), high grade dysplasia in 128 (56%), low grade dysplasia in 16 (7%), non-dysplastic Barrett’s in 5 (2%), and 8 junctional lesions (4%). The EMR was performed using CAP in 166 (73%) and BAND in 62 (27%). The mean diameter of resections was 1.1⫾0.4 cm with a depth of 0.6⫾0.2 cm. Only 24% of resections had clear peripheral margins. The ability to obtain clear margins was not influenced by histology, procedure type, or endoscopic appearance, p⬎0.05. A direct correlation between size of the EMR and clear margins of resection could not made, but all patients with clear margins had an EMR diameter of greater than1 cm (p⬍0.04). Conclusions: EMR can completely resect areas of dysplasia or cancer in a minority (24%) of occasions. This may be secondary to the diffuse nature of these neoplastic lesions in Barrett’s esophagus. Treatment of larger areas of tissue is needed by either additional EMR or combining this therapy with photodynamic therapy. 84 PATIENTS WITH EROSIVE ESOPHAGITIS RELAPSE LESS FREQUENTLY AND TO LOWER GRADES AFTER TREATMENT WITH PANTOPRAZOLE V RANITIDINE David C. Metz, M.D.*, Polly Fraga, M.D., Michael E. Mack, Ph.D., Seymour M. Sabesin, M.D. University of Pennsylvania Health Systen, Philadelphia, PA; Wyeth Research, Collegeville, PA and RushPresbyterian-St.Luke’s Medical Center, Chicago, IL. Purpose: To determine the relationship between maintenance treatment regimens, relapse frequency, and endoscopic severity of relapse in patients with previously treated erosive esophagitis who relapsed during follow-up for up to 12 months. Methods: GERD patients with endoscopically documented healed (grade 0 or 1 Hetzel-Dent score) erosive esophagitis (EE) were enrolled in two one-year, double-blind, comparator-controlled clinical studies to compare the efficacy and safety of pantoprazole (PAN) and ranitidine (RAN) in the maintenance of healing. Six hundred fifty-two (652) patients were randomly assigned to receive PAN 10, 20, or 40 mg QD or RAN 150 mg BID. Upper endoscopy was performed at months 1, 3, 6, and 12 or when GERD symptoms recurred. Relapse was defined as the reappearance of EE, endoscopic grade ⱖ 2, within 12 months of the start of maintenance therapy. Results: Both treatments were well tolerated. After 12 months of treatment PAN 20 and PAN 40 mg were significantly (p⬍0.001) more effective than RAN in maintaining EE healing in both studies with 21%, 46%, 55% and 78% (study A) and 33%, 40%, 68%, and 82% (study B) remaining healed in the RAN and PAN 10, 20, and 40 mg groups, respectively. In addition, when analyzed according to grade of relapse, significantly fewer patients in the PAN 20 and PAN 40 groups relapsed to grades 3 or 4 than in the RAN group (p⬍0.05) (Table 1). Table 1: Relapse by Treatment Group
Study A PAN 10 mg QD PAN 20 mg QD PAN 40 mg QD RAN 150 mg BID Study B PAN 10 mg QD PAN 20 mg QD PAN 40 mg QD RAN 150 mg BID
No. of Patients
Relapse to Grade 3 or 4 n (%)
85 89 81 86
8 (9) 0 2 (2) 11 (13)
87 92 94 96
7 (8) 4 (4) 7 (7) 17 (18)
82 THE CORRELATION OF ACID REFLUX SYMPTOMS WITH AMBULATORY PH MONITORING: A RETROSPECTIVE ANALYSIS Marc R. Happe D.O., Andrew C. Gorske, M.D., Corinne L. Maydonovitch, B.S., Lavern S. Belle, B.S., Roy K.H. Wong, M.D.*. Walter Reed Army Medical Center, Washington, DC and Darnall Army Community Hospital, Fort Hood, TX. Purpose: Despite the growing use and number of GERD symptom questionnaires, limited data exists correlating reflux symptoms to the results of diagnostic tests. This study examined the association of reflux symptoms in relation to objective measures of acid reflux by pH monitoring in a cohort of patients presenting for esophageal motility and pH testing. Methods: 537 charts from patients undergoing esophageal motility/pH testing at the Walter Reed Army Medical Center from 1997 and 1998 were reviewed. Prior to manometry, patients completed a questionnaire concerning the presence of GERD symptoms, smoking history, and body position while sleeping. Exclusion criteria included: testing on acid suppression medications, achalasia, nutcracker esophagus, hypertensive LESp, previous anti-reflux surgery or incomplete data. 220 charts met inclusion criteria (M:F 145:75; Mean age⫾ SD: 42⫾14 yrs). A 24-hour Johnson/DeMeester (J/D) score ⬎ 20 was considered abnormal. Results: 87% (189/218) of patients reported heartburn. Of all GERD symptoms assessed (heartburn, chest pain, dysphagia, regurgitation, sour taste, and belching), only heartburn was an independent predictor of an abnormal 24-hour pH score (p⫽0.015). Heartburn ⫹ (HB⫹) patients had significantly more reflux [% total time pH ⬍ 4 (p⫽0.048) and a higher J/D score (p⫽0.050)] than patients without heartburn. HB⫹ patients were 2.72 times (95% CI, 1.2– 6.1) more likely to have an abnormal 24-hour pH score. When further evaluating four specific heartburn descriptors (pressure, sharp pain, constant burning, or ascending burning sensation), no significant differences were noted in reflux parameters or LESp. Patients with nocturnal heartburn (HBn ⫹) had significantly higher J/D scores (43 vs. 29), % total (8.2% vs. 5.5%), % upright (9.0% vs. 6.3%), and % supine reflux (6.5% vs. 3.8%) compared to HBn ⫺ patients (p⬍0.05). Interestingly, there was no significant difference between sleeping position (left, right, back, stomach, no preference) and abnormal pH score. Smokers (past or current), however, were 2.22 times (95% CI, 1.2– 4.1) more likely to have an abnormal pH score as compared to non-smokers (p⫽0.024). Conclusions: (1) These data support existing literature that the symptom of heartburn is the single best predictor of acid reflux. (2) Patients with nocturnal heartburn and smokers have the worst reflux. Aggressive GERD treatment and surveillance may be warranted in these patients. 83 CAN ENDOSCOPIC MUCOSAL RESECTION COMPLETELY REMOVE CANCER OR DYSPLASIA IN BARRETTS ESOPHAGUS? Kenneth K. Wang, M.D.*, Lori Lutzke, Navtej S. Buttar, M.D., Michel WongKeeSong, M.D., Sarah Wandersee. Mayo Clinic, Rochester, MN. Purpose: Endoscopic mucosal resection (EMR) has been used to treat early cancers and dysplasia within Barrett’s esophagus. We reviewed our experience with this technique between 1990 –2003. Aim: To determine the ability of EMR to completely resect lesions within Barrett’s esophagus. Methods: All patients seen in the Barrett’s Esophagus Unit were eligible for entry. Patients with suspected cancers or high grade dysplasia were initially evaluated with EUS to determine if invasion or metastasis occurred. Patients had EMR performed by two different techniques. All were initially injected with 5–20 ml of diluted epinephrine. After the lesion was lifted, a pseudopolyp was created by use of an endoscopic variceal ligating device between 1990 –2000. This BAND technique was completed by using a small snare to remove the lesion. After 4/2000, we used a CAP technique which allowed the tissue to be suctioned into a EMR cap that had
Abstracts
S29
a pre-formed snare positioned at the distal lip of the cap. Tissue was examined by experienced gastrointestinal pathologist. All procedures were performed by a single experienced endoscopist. Results: 171 patients aged 66⫾1 years with biopsy proven Barrett’s esophagus (140 males and 31 females) were treated with EMR. These patients had a mean Barrett’s length of 5 centimeters. These patients had 228 (range 1–5) mucosal resections performed on 92 (40%) solitary nodules, 77 (34%) areas of nodularity, 32 (14%) areas of mucosal irregularity, and 27 miscellaneous other lesions. The initial diagnosis was cancer in 71 (31%), high grade dysplasia in 128 (56%), low grade dysplasia in 16 (7%), non-dysplastic Barrett’s in 5 (2%), and 8 junctional lesions (4%). The EMR was performed using CAP in 166 (73%) and BAND in 62 (27%). The mean diameter of resections was 1.1⫾0.4 cm with a depth of 0.6⫾0.2 cm. Only 24% of resections had clear peripheral margins. The ability to obtain clear margins was not influenced by histology, procedure type, or endoscopic appearance, p⬎0.05. A direct correlation between size of the EMR and clear margins of resection could not made, but all patients with clear margins had an EMR diameter of greater than1 cm (p⬍0.04). Conclusions: EMR can completely resect areas of dysplasia or cancer in a minority (24%) of occasions. This may be secondary to the diffuse nature of these neoplastic lesions in Barrett’s esophagus. Treatment of larger areas of tissue is needed by either additional EMR or combining this therapy with photodynamic therapy. 84 PATIENTS WITH EROSIVE ESOPHAGITIS RELAPSE LESS FREQUENTLY AND TO LOWER GRADES AFTER TREATMENT WITH PANTOPRAZOLE V RANITIDINE David C. Metz, M.D.*, Polly Fraga, M.D., Michael E. Mack, Ph.D., Seymour M. Sabesin, M.D. University of Pennsylvania Health Systen, Philadelphia, PA; Wyeth Research, Collegeville, PA and RushPresbyterian-St.Luke’s Medical Center, Chicago, IL. Purpose: To determine the relationship between maintenance treatment regimens, relapse frequency, and endoscopic severity of relapse in patients with previously treated erosive esophagitis who relapsed during follow-up for up to 12 months. Methods: GERD patients with endoscopically documented healed (grade 0 or 1 Hetzel-Dent score) erosive esophagitis (EE) were enrolled in two one-year, double-blind, comparator-controlled clinical studies to compare the efficacy and safety of pantoprazole (PAN) and ranitidine (RAN) in the maintenance of healing. Six hundred fifty-two (652) patients were randomly assigned to receive PAN 10, 20, or 40 mg QD or RAN 150 mg BID. Upper endoscopy was performed at months 1, 3, 6, and 12 or when GERD symptoms recurred. Relapse was defined as the reappearance of EE, endoscopic grade ⱖ 2, within 12 months of the start of maintenance therapy. Results: Both treatments were well tolerated. After 12 months of treatment PAN 20 and PAN 40 mg were significantly (p⬍0.001) more effective than RAN in maintaining EE healing in both studies with 21%, 46%, 55% and 78% (study A) and 33%, 40%, 68%, and 82% (study B) remaining healed in the RAN and PAN 10, 20, and 40 mg groups, respectively. In addition, when analyzed according to grade of relapse, significantly fewer patients in the PAN 20 and PAN 40 groups relapsed to grades 3 or 4 than in the RAN group (p⬍0.05) (Table 1). Table 1: Relapse by Treatment Group
Study A PAN 10 mg QD PAN 20 mg QD PAN 40 mg QD RAN 150 mg BID Study B PAN 10 mg QD PAN 20 mg QD PAN 40 mg QD RAN 150 mg BID
No. of Patients
Relapse to Grade 3 or 4 n (%)
85 89 81 86
8 (9) 0 2 (2) 11 (13)
87 92 94 96
7 (8) 4 (4) 7 (7) 17 (18)