- Email: [email protected]
Urinary Incontinence are Maintained After Switching the Stimulator off
AGA Abstracts
of high voltage and low pulse duration which vary both in frequency and duration. FREMS enhances microvascular blood flow and modulates the expression of angiogenic growth factors and cytokines. Aim: to investigate the effects of FREMS in an experimental model of acute inflammatory colitis. Material and methods: We used an established model of TNBSinduced colitis in guinea pigs. Colitis was induced by transanal administration of TNBS (15 mg/250 g of body weight in 30% ethanol) in 14 animals. An additional group of guinea pigs (n=3) did not receive TNBS and was used as normal control. Successful induction of colitis was confirmed in all cases by positive fecal occult blood tests. One week after the induction of colitis, animals were randomized to the FREMS therapy group (n=7) or the control group (n=7). After 3 weeks, animals were sacrificed and colons were harvested and used for analysis. Results: Treatment with FREMS significantly decreased the severity of TNBS-induced colonic damages, as assessed both macroscopically and histologically by using established scoring systems that account for mucosal ulceration and atrophy, edema of the submucosa, inflammatory cell infiltration, and vascular dilatation. The macroscopic score of colonic damage was 2.1 in the FREMS group and 7.5 in the control group (P<0.01). The histological score of colonic damage was 2.1 in the FREMS group and 6.6 in the control group (P<0.01). FREMS therapy normalizes colonic vascularization and significantly increases the number of regenerating nerve fibers, as assessed by GAP43 immunostaining (P<0.001). Finally, the expression of TNF-alpha in the colon of animals treated with FREMS was more than 3 times lower than in the control group (4.1 vs. 14.8 pg/ml, P<0.0001). Conclusions: FREMS has significant beneficial effects in an experimental model of acute inflammatory colitis and merits further investigation as novel therapeutic strategy in inflammatory bowel diseases.
month; p=0.05 for ICIQ) After a median follow up of 6 months (range 1-6) with the stimulator OFF the improvement in FI/UI was maintained in 11/17 patients with an AMS score of 28.7 vs 51.45, P= 0.16; Wexner' score of 3.3 vs 4.45, P= 0.47. FIQL score (93 vs 98.6, P= 0.57), UI (ICIQ 6.1 vs 7.1, P= 0.78) and mean number of episodes of major incontinence per month (0.9 vs 2.9 P=0.18). Five patients had symptoms recurrence after the first month OFF and 1 more patient after 6 months Conclusions: Our study shows for the first time that after a long period of SNS its effects on FI and UI are maintained in most of patients keepeng the stimulator OFF, at least in the short term. Although this data needs to be confirmed by longer follow-up on a larger cohort of patients, they shed a new light and questions about the pathophysiology of neurological mechanisms involved in the control of FI and UI, suggesting that a sufficiently long stimulation could set-up a deranged mechanisms of control of the continence Tu1329 Using Hyoscine Butylbromide in IBS-a Patients With a Pain Syndrome Evgeny I. Sas, Vladimir Grinevich INTRODUCTION: Hyoscine butylbromide - selective M3 Cholinolytic (HB) is effective treatment in abdominal pain predominant irritable bowel syndrome (IBS-A). AIMS & METHODS: To assess the efficacy of HB in IBS-A patients in a 2 centre randomised, doubleblind, placebo-controlled, crossover trial. 102 patients meeting the Rome 3 criteria for IBSA were recruited. Screening blood tests and rectal biopsy were followed by a 1 week baseline Bristol stool form diary before randomisation to placebo or HB for 5 weeks. Drug effect was optimised by dose titration during weeks 1-2 starting at 30 mg daily, increasing (max 60 mg t.d.s) or decreasing as required. A 2 week washout preceded a further 4 weeks of the opposite therapy to that received in treatment 1. Symptom diaries including stool form, frequency, pain, bloating and urgency were completed daily. The primary endpoint was the difference in average stool form between baseline and the last 2 weeks of each treatment. Analysis is presented by intention to treat. RESULTS: 70 women and 32 men completed the study (mean age 34.5, range 19-43, and 32.1, range 22-42.1 respectively). The mode dose of HB was less than 40 mg a day. Stool form was significantly improved in the HB arm, mean change 1.4 (95% confidence interval [CI] 1.3-1.5), vs. 0.5 (CI 0.3-0.5) than placebo, p = 0.001. Stool frequency improved on HB, mean 1.2 (CI 1.2-0.8), vs. 0.6 (CI 0.7-0.4), p = 0.005, as did urgency score 0.7 (CI 0.8-0.5) vs. 0.4 (CI 0.5-0.3) p = 0.005; pain sensations after treatment decreased significantly (mean=24 points in scale IBS-QoL30). The IBS severity score when compared to baseline decreased by 84 points (CI 61-98) in the HB arm, compared to a 46 point (CI 31-57) reduction with placebo, p = 0.005. 76% of patients preferred HB while 24% preferred placebo or had no preference, Chi squared p = 0.001. 74% of patients reported adequate relief from their IBS symptoms whilst taking HB compared with 21% on placebo. CONCLUSION: Using Hyoscine butylbromide is highly effective in IBS-A with a pain syndrome.
Tu1327a Golimumab for Treatment of Moderate to Severe Anti-TNF Refaractory Crohn's Disease: Open Label Experience Ofer Ben-Bassat, Anna Iacono, Sue P. Irwin, Mark S. Silverberg, Gordon R. Greenberg Background /Aims: Between 25%-40% of patients (pts) with Crohn's disease (CD) who initially benefit from infliximab (IFX) lose response during maintenance treatment. Switching to a second anti-TNF agent provides benefit only for a minority of pts. These observations suggest the requirement for out of class biologics because TNF may no longer be a dominant cytokine contributing to disease activity. Golimumab (GOL) is an IgG1 monoclonal antibody to TNF with greater affinity to TNF and neutralizing capacity In Vitro compared with adalimumab. Randomized trials indicate GOL benefits active rheumatoid arthritis. We evaluated the efficacy of GOL for pts with moderate to severe CD who failed other biologics, including anti-TNF drugs. Methods: Patients with moderate to severe CD disease who had lost response to IFX and failed a second anti-TNF agent and/or an out of class biologic were treated with scheduled GOL administered SC at 2 week (wk) intervals. Three dose induction of 50mg (n=1), 100mg (n=1), and 200mg (n=5) was administered. Maintenance dosing was continued at 2 wk intervals with dose escalation at 12 wk if the CDAI decrement was < 100 or if loss of response occurred beyond 12 wk. CDAI and blood chemistry were obtained at baseline and regular follow-up visits. Results: Nine pts with moderate to severe CD of the colon (n=8) or ileum (n=1) had failed IFX, 4 of whom had antibodies to IFX. Other prior therapies included adalimumab (n=7), certolizumab (n=5) and ustekinumab (n=3). At baseline, 6 pts were receiving steroids (4 prednisone, 2 budesonide), the median CDAI was 409 (IQR: 274-489), median CRP was 25 (IQR: 9.1-38.15), and all pts had active ulceration at colonoscopy. At 12 wk follow-up, clinical response occurred in 6 pts and 5 pts (56%) achieved steroid-free remission. Two pts required dose escalation (100mg to 150 mg; 200mg to 400mg) and achieved steroid-free remission. Endoscopic improvement >75% occurred in 6 evaluated pts, of whom 5 achieved complete mucosal healing (median interval from baseline 15 months; range: 6-39). One patient at GOL 50mg had improvement of arthritis but no intestinal response. After 14 months GOL 200mg, 1 patient had clinical and endoscopic relapse but regained clinical response with re-induction GOL 400mg. After a median follow-up of 17 months (range: 3-24) on GOL, clinical benefit has been sustained in 8 pts, 7 (78%) of whom remain in steroid-free remission. No adverse events have been recorded. Conclusions: Our findings indicate pts with moderate to severe CD who have lost response to anti-TNF therapies and an out of class biologic, derive clinical benefit from treatment with GOL suggesting TNF-α remains a dominant cytokine contributing to disease activity in such pts. Randomized trials to evaluate the efficacy and optimal dosing of GOL for moderate to severe CD are warranted.
Tu1330 Impacts of Less Invasive Treatments Including Sclerotherapy With Alta and Pph for Prolapsing Internal Hemorrhoids: Comparison With Hemorrhoidectomy Yukihiko Tokunaga, Hirokazu Sasaki Backgrounds: For prolasing internal hemorrhoids, less invasive treatments such as sclerotherapy using aluminum potassium sulphate / tannic acid (ALTA), and procedure for prolapse and hemorrhoids (PPH) have been introduced recently. We compared the results of ALTA and PPH with conventional hemorrhoidectomy. Methods: Between January 2006 and March 2009, We performed conventional hemorrhoidectomy in 464 pantients, ALTA in 940 patients, and PPH in 148 patients with second- and third-degree internal hemorrhoids according to the Goligher's classification. Results: The operation duration was significantly longer (p<0.01) in LE (43±5 min) (m±SD) than in ALTA (13±2 min). Volume of ALTA injected into a hemorrhoid was 7.3±2.2mL. Post operative pain, which needed intravenous injection of pain killer, occurred in 65 cases (14%) in LE and 16 cases (1.7%) in ALTA (p<0.01). ALTA could be performed on an outpatient basis without any severe complication such as abscess, ulcer, and stenosis. Hospital stays were 6.7±2.0 days for hemorrhoidectomy, and 4.1±1.5 days for PPH. The dissapearnace rates of prolapse were 100% in hemorroidectomy, 96% in ALTA, and 99% in PPH respectively. Conclusions: Conventional hemorrhoidectomy would be indicated for alomost all cases of prolapsing internal hemorroids. However, it needs hospitalization, being accompanied with post-operative pain. ALTA is feasible on outpatient bases without any severe pain or complication. PPH is an useful alternative treatment with shorter period of hospitalization and less pain compared to hemorrhoidectomy. Less invasive treatments would be useful and should be performed in appropriate cases, paying attention to avoid complications.
Tu1328 The Effects of Sacral Nerve Stimulation on Fecal/Urinary Incontinence are Maintained After Switching the Stimulator off Ivana Giannini, Simona Giuratrabocchetta, Mirna Tondo, Rosa Digennaro, Marcella Rinaldi, Donato F. Altomare Background: Sacral Nerve Stimulation (SNS) has widely been recognized as an effective and safe treatment for fecal incontinence (FI), urinary incontinence (UI), constipation and urinary retention despite its mechanism of action and neurological pathways are still uncertain. Involvement of the central nervous system and a “setting up” of the neurological mechanisms appointed to the control of the pelvic function have been hypothesized. Aim of the study was to evaluate whether a prolonged period of SNS could set-up the neurological mechanisms involved in the control of continence. Methods: Patients under permanent SNS for FI/UI, for at least 1 year, were asked to switch the stimulator OFF for a temporary period and to record the result by filling a diary of defecation and questionnaires on UI (ICIQ SF), Qol (FIQL) and FI (AMS score, Wexner' score). In case of symptoms recurrence the stimulator was switched ON, on the contrary the patients were scheduled for a 1 year followed up. Pre-implant and post-implant data were compared, and then the results recorded with the stimulator OFF were compared with post-implant data (stimulator ON). A Student's t test for paired samples was used for statistical analysis taking a p<0.05 as statistically significant. Results: After informed consent 17 patients (median age 59 years, range between 35-70, 15/17 females) entered the study. 11 patients were affected by FI and UI and 5 by FI only. One more patients had FI, UI and constipation together. The severity of diseases and QoL questionnaires were significantly improved with the stimulator ON compared with the baseline (p<0.0001 for FIQL, Wexner' score, AMS and episodes of major incontinence/
AGA Abstracts
Tu1331 Visible Light Spectroscopy in Diagnosis of Chronic Gastrointestinal Ischemia: Results of a Cohort Study Aria Sana, Leon M. Moons, Bettina E. Hansen, Pieter Dewint, Désirée van Noord, Peter Mensink, Ernst J. Kuipers Introduction: Chronic gastrointestinal ischemia (CGI) is more common than previously thought. Present-day diagnostics including CT angiography and functional testing by means of the recently introduced visible light spectroscopy (VLS) contribute to diagnosis and selection of patients who are eligible for treatment. The aim of this study was to evaluate the treatment response in patients with consensus diagnosis of occlusive CGI. Methods: Patients referred to our tertiary center for evaluation of CGI were prospectively included. All patients had a standard work-up, consisting of evaluation of symptoms, CT-or MR angiography for evaluation of gastrointestinal arterial patency, and functional assessment of mucosal perfusion by VLS. After discussion in a multidisciplinary team, a consensus on presence or absence of CGI was reached, and patients with occlusive CGI were offered
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of high voltage and low pulse duration which vary both in frequency and duration. FREMS enhances microvascular blood flow and modulates the expression of angiogenic growth factors and cytokines. Aim: to investigate the effects of FREMS in an experimental model of acute inflammatory colitis. Material and methods: We used an established model of TNBSinduced colitis in guinea pigs. Colitis was induced by transanal administration of TNBS (15 mg/250 g of body weight in 30% ethanol) in 14 animals. An additional group of guinea pigs (n=3) did not receive TNBS and was used as normal control. Successful induction of colitis was confirmed in all cases by positive fecal occult blood tests. One week after the induction of colitis, animals were randomized to the FREMS therapy group (n=7) or the control group (n=7). After 3 weeks, animals were sacrificed and colons were harvested and used for analysis. Results: Treatment with FREMS significantly decreased the severity of TNBS-induced colonic damages, as assessed both macroscopically and histologically by using established scoring systems that account for mucosal ulceration and atrophy, edema of the submucosa, inflammatory cell infiltration, and vascular dilatation. The macroscopic score of colonic damage was 2.1 in the FREMS group and 7.5 in the control group (P<0.01). The histological score of colonic damage was 2.1 in the FREMS group and 6.6 in the control group (P<0.01). FREMS therapy normalizes colonic vascularization and significantly increases the number of regenerating nerve fibers, as assessed by GAP43 immunostaining (P<0.001). Finally, the expression of TNF-alpha in the colon of animals treated with FREMS was more than 3 times lower than in the control group (4.1 vs. 14.8 pg/ml, P<0.0001). Conclusions: FREMS has significant beneficial effects in an experimental model of acute inflammatory colitis and merits further investigation as novel therapeutic strategy in inflammatory bowel diseases.
month; p=0.05 for ICIQ) After a median follow up of 6 months (range 1-6) with the stimulator OFF the improvement in FI/UI was maintained in 11/17 patients with an AMS score of 28.7 vs 51.45, P= 0.16; Wexner' score of 3.3 vs 4.45, P= 0.47. FIQL score (93 vs 98.6, P= 0.57), UI (ICIQ 6.1 vs 7.1, P= 0.78) and mean number of episodes of major incontinence per month (0.9 vs 2.9 P=0.18). Five patients had symptoms recurrence after the first month OFF and 1 more patient after 6 months Conclusions: Our study shows for the first time that after a long period of SNS its effects on FI and UI are maintained in most of patients keepeng the stimulator OFF, at least in the short term. Although this data needs to be confirmed by longer follow-up on a larger cohort of patients, they shed a new light and questions about the pathophysiology of neurological mechanisms involved in the control of FI and UI, suggesting that a sufficiently long stimulation could set-up a deranged mechanisms of control of the continence Tu1329 Using Hyoscine Butylbromide in IBS-a Patients With a Pain Syndrome Evgeny I. Sas, Vladimir Grinevich INTRODUCTION: Hyoscine butylbromide - selective M3 Cholinolytic (HB) is effective treatment in abdominal pain predominant irritable bowel syndrome (IBS-A). AIMS & METHODS: To assess the efficacy of HB in IBS-A patients in a 2 centre randomised, doubleblind, placebo-controlled, crossover trial. 102 patients meeting the Rome 3 criteria for IBSA were recruited. Screening blood tests and rectal biopsy were followed by a 1 week baseline Bristol stool form diary before randomisation to placebo or HB for 5 weeks. Drug effect was optimised by dose titration during weeks 1-2 starting at 30 mg daily, increasing (max 60 mg t.d.s) or decreasing as required. A 2 week washout preceded a further 4 weeks of the opposite therapy to that received in treatment 1. Symptom diaries including stool form, frequency, pain, bloating and urgency were completed daily. The primary endpoint was the difference in average stool form between baseline and the last 2 weeks of each treatment. Analysis is presented by intention to treat. RESULTS: 70 women and 32 men completed the study (mean age 34.5, range 19-43, and 32.1, range 22-42.1 respectively). The mode dose of HB was less than 40 mg a day. Stool form was significantly improved in the HB arm, mean change 1.4 (95% confidence interval [CI] 1.3-1.5), vs. 0.5 (CI 0.3-0.5) than placebo, p = 0.001. Stool frequency improved on HB, mean 1.2 (CI 1.2-0.8), vs. 0.6 (CI 0.7-0.4), p = 0.005, as did urgency score 0.7 (CI 0.8-0.5) vs. 0.4 (CI 0.5-0.3) p = 0.005; pain sensations after treatment decreased significantly (mean=24 points in scale IBS-QoL30). The IBS severity score when compared to baseline decreased by 84 points (CI 61-98) in the HB arm, compared to a 46 point (CI 31-57) reduction with placebo, p = 0.005. 76% of patients preferred HB while 24% preferred placebo or had no preference, Chi squared p = 0.001. 74% of patients reported adequate relief from their IBS symptoms whilst taking HB compared with 21% on placebo. CONCLUSION: Using Hyoscine butylbromide is highly effective in IBS-A with a pain syndrome.
Tu1327a Golimumab for Treatment of Moderate to Severe Anti-TNF Refaractory Crohn's Disease: Open Label Experience Ofer Ben-Bassat, Anna Iacono, Sue P. Irwin, Mark S. Silverberg, Gordon R. Greenberg Background /Aims: Between 25%-40% of patients (pts) with Crohn's disease (CD) who initially benefit from infliximab (IFX) lose response during maintenance treatment. Switching to a second anti-TNF agent provides benefit only for a minority of pts. These observations suggest the requirement for out of class biologics because TNF may no longer be a dominant cytokine contributing to disease activity. Golimumab (GOL) is an IgG1 monoclonal antibody to TNF with greater affinity to TNF and neutralizing capacity In Vitro compared with adalimumab. Randomized trials indicate GOL benefits active rheumatoid arthritis. We evaluated the efficacy of GOL for pts with moderate to severe CD who failed other biologics, including anti-TNF drugs. Methods: Patients with moderate to severe CD disease who had lost response to IFX and failed a second anti-TNF agent and/or an out of class biologic were treated with scheduled GOL administered SC at 2 week (wk) intervals. Three dose induction of 50mg (n=1), 100mg (n=1), and 200mg (n=5) was administered. Maintenance dosing was continued at 2 wk intervals with dose escalation at 12 wk if the CDAI decrement was < 100 or if loss of response occurred beyond 12 wk. CDAI and blood chemistry were obtained at baseline and regular follow-up visits. Results: Nine pts with moderate to severe CD of the colon (n=8) or ileum (n=1) had failed IFX, 4 of whom had antibodies to IFX. Other prior therapies included adalimumab (n=7), certolizumab (n=5) and ustekinumab (n=3). At baseline, 6 pts were receiving steroids (4 prednisone, 2 budesonide), the median CDAI was 409 (IQR: 274-489), median CRP was 25 (IQR: 9.1-38.15), and all pts had active ulceration at colonoscopy. At 12 wk follow-up, clinical response occurred in 6 pts and 5 pts (56%) achieved steroid-free remission. Two pts required dose escalation (100mg to 150 mg; 200mg to 400mg) and achieved steroid-free remission. Endoscopic improvement >75% occurred in 6 evaluated pts, of whom 5 achieved complete mucosal healing (median interval from baseline 15 months; range: 6-39). One patient at GOL 50mg had improvement of arthritis but no intestinal response. After 14 months GOL 200mg, 1 patient had clinical and endoscopic relapse but regained clinical response with re-induction GOL 400mg. After a median follow-up of 17 months (range: 3-24) on GOL, clinical benefit has been sustained in 8 pts, 7 (78%) of whom remain in steroid-free remission. No adverse events have been recorded. Conclusions: Our findings indicate pts with moderate to severe CD who have lost response to anti-TNF therapies and an out of class biologic, derive clinical benefit from treatment with GOL suggesting TNF-α remains a dominant cytokine contributing to disease activity in such pts. Randomized trials to evaluate the efficacy and optimal dosing of GOL for moderate to severe CD are warranted.
Tu1330 Impacts of Less Invasive Treatments Including Sclerotherapy With Alta and Pph for Prolapsing Internal Hemorrhoids: Comparison With Hemorrhoidectomy Yukihiko Tokunaga, Hirokazu Sasaki Backgrounds: For prolasing internal hemorrhoids, less invasive treatments such as sclerotherapy using aluminum potassium sulphate / tannic acid (ALTA), and procedure for prolapse and hemorrhoids (PPH) have been introduced recently. We compared the results of ALTA and PPH with conventional hemorrhoidectomy. Methods: Between January 2006 and March 2009, We performed conventional hemorrhoidectomy in 464 pantients, ALTA in 940 patients, and PPH in 148 patients with second- and third-degree internal hemorrhoids according to the Goligher's classification. Results: The operation duration was significantly longer (p<0.01) in LE (43±5 min) (m±SD) than in ALTA (13±2 min). Volume of ALTA injected into a hemorrhoid was 7.3±2.2mL. Post operative pain, which needed intravenous injection of pain killer, occurred in 65 cases (14%) in LE and 16 cases (1.7%) in ALTA (p<0.01). ALTA could be performed on an outpatient basis without any severe complication such as abscess, ulcer, and stenosis. Hospital stays were 6.7±2.0 days for hemorrhoidectomy, and 4.1±1.5 days for PPH. The dissapearnace rates of prolapse were 100% in hemorroidectomy, 96% in ALTA, and 99% in PPH respectively. Conclusions: Conventional hemorrhoidectomy would be indicated for alomost all cases of prolapsing internal hemorroids. However, it needs hospitalization, being accompanied with post-operative pain. ALTA is feasible on outpatient bases without any severe pain or complication. PPH is an useful alternative treatment with shorter period of hospitalization and less pain compared to hemorrhoidectomy. Less invasive treatments would be useful and should be performed in appropriate cases, paying attention to avoid complications.
Tu1328 The Effects of Sacral Nerve Stimulation on Fecal/Urinary Incontinence are Maintained After Switching the Stimulator off Ivana Giannini, Simona Giuratrabocchetta, Mirna Tondo, Rosa Digennaro, Marcella Rinaldi, Donato F. Altomare Background: Sacral Nerve Stimulation (SNS) has widely been recognized as an effective and safe treatment for fecal incontinence (FI), urinary incontinence (UI), constipation and urinary retention despite its mechanism of action and neurological pathways are still uncertain. Involvement of the central nervous system and a “setting up” of the neurological mechanisms appointed to the control of the pelvic function have been hypothesized. Aim of the study was to evaluate whether a prolonged period of SNS could set-up the neurological mechanisms involved in the control of continence. Methods: Patients under permanent SNS for FI/UI, for at least 1 year, were asked to switch the stimulator OFF for a temporary period and to record the result by filling a diary of defecation and questionnaires on UI (ICIQ SF), Qol (FIQL) and FI (AMS score, Wexner' score). In case of symptoms recurrence the stimulator was switched ON, on the contrary the patients were scheduled for a 1 year followed up. Pre-implant and post-implant data were compared, and then the results recorded with the stimulator OFF were compared with post-implant data (stimulator ON). A Student's t test for paired samples was used for statistical analysis taking a p<0.05 as statistically significant. Results: After informed consent 17 patients (median age 59 years, range between 35-70, 15/17 females) entered the study. 11 patients were affected by FI and UI and 5 by FI only. One more patients had FI, UI and constipation together. The severity of diseases and QoL questionnaires were significantly improved with the stimulator ON compared with the baseline (p<0.0001 for FIQL, Wexner' score, AMS and episodes of major incontinence/
AGA Abstracts
Tu1331 Visible Light Spectroscopy in Diagnosis of Chronic Gastrointestinal Ischemia: Results of a Cohort Study Aria Sana, Leon M. Moons, Bettina E. Hansen, Pieter Dewint, Désirée van Noord, Peter Mensink, Ernst J. Kuipers Introduction: Chronic gastrointestinal ischemia (CGI) is more common than previously thought. Present-day diagnostics including CT angiography and functional testing by means of the recently introduced visible light spectroscopy (VLS) contribute to diagnosis and selection of patients who are eligible for treatment. The aim of this study was to evaluate the treatment response in patients with consensus diagnosis of occlusive CGI. Methods: Patients referred to our tertiary center for evaluation of CGI were prospectively included. All patients had a standard work-up, consisting of evaluation of symptoms, CT-or MR angiography for evaluation of gastrointestinal arterial patency, and functional assessment of mucosal perfusion by VLS. After discussion in a multidisciplinary team, a consensus on presence or absence of CGI was reached, and patients with occlusive CGI were offered
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