Susie Cheng

A Controlled Study of Ranitidine for the Prevention of Recurrent Hemorrhage from Duodenal Ulcer

BACKGROUND Hemorrhage is the most common complication of duodenal ulcer disease, but there is little information about the effectiveness and safety of long-term maintenance therapy with histamine H2-receptor blockers. METHODS We conducted a double-blind study in patients with endoscopically documented hemorrhage from duodenal ulcers. Patients were randomly assigned to maintenance therapy with ranitidine (150 mg at night) or placebo and were followed for up to three years. Endoscopy was performed at base line (to document that the ulcers had healed), at exit from the study, and when a patient had persistent ulcer symptoms unrelieved by antacids or had gastrointestinal bleeding. Symptomatic relapses without bleeding were treated with ranitidine; if the ulcer healed within eight weeks, the patient resumed taking the assigned study medication. RESULTS The two groups were similar at entry, which usually occurred about three months after the index hemorrhage. After a mean follow-up of 61 weeks, 3 of the 32 patients treated with ranitidine had recurrent hemorrhage, as compared with 12 of the 33 given placebo (P < 0.05). Half the episodes of recurrent bleeding were asymptomatic. One patient in the ranitidine group withdrew from the study because of asymptomatic thrombocytopenia during the first month. CONCLUSIONS For patients whose duodenal ulcers heal after severe hemorrhage, long-term maintenance therapy with ranitidine is safe and reduces the risk of recurrent bleeding.

An economic analysis of patients with active arterial peptic ulcer hemorrhage treated with endoscopic heater probe, injection sclerosis, or surgery in a prospective, randomized trial☆☆☆★★★

BACKGROUND There are no published, detailed assessments of the direct costs of endoscopic hemostasis for actively bleeding peptic ulcers. We compared the direct costs of care for patients with active ulcer hemorrhage treated with endoscopic or medical-surgical therapies and correlated these costs with patient outcomes. METHODS In a prospective, randomized, controlled trial, 31 patients with active ulcer hemorrhage at emergency endoscopy were randomly assigned to heater probe, injection, or medical-surgical treatment. For further ulcer bleeding, heater probe and injection patients were re-treated endoscopically and medical-surgical patients were referred for surgery. Direct costs were estimated using fixed and variable costs for resources consumed and Medicare reimbursement rates for physician fees. RESULTS Compared to medical-surgical treatment, the heater probe and injection groups had significantly higher primary hemostasis rates (100% and 90% vs 8%) and lower rates of emergency surgery (0% and 10% vs 75%), blood transfusions, and median direct costs per patient (

Prospective randomized comparative study of bipolar electrocoagulation versus heater probe for treatment of chronically bleeding internal hemorrhoids

4153 and

⁎⁎⁎4461 Randomized, controlled trial of medical therapy compared with endoscopic therapy for prevention of recurrent ulcer hemorrhage in patients with non-bleeding adherent clots.

5247 vs

Resolution of chronic anal fissures after treatment of contiguous internal hemorrhoids with direct current probe

11,149). Furthermore, compared to medical-surgical treatment, the heater probe group had a significantly lower incidence of severe ulcer rebleeding (11% vs 75%). CONCLUSIONS Heater probe and injection sclerosis are similarly efficacious treatments for active ulcer hemorrhage, and both treatments yield significantly lower direct costs of medical care and cost savings.

Prevalence of H. pylori and aspirin or NSAID utilization in patients with ulcer hemorrhage: Results of screening for a large multicenter U.S. trial

BACKGROUND Our purpose was to compare the efficacy, complications, failure rates, and crossovers of heater and bipolar probe treatments of chronically bleeding internal hemorrhoids. METHODS Eighty-one patients (31 female, 50 male) with mean age of 53 years had large (grade 2 to 3) internal hemorrhoids with bleeding for a mean of 12 years, had failed medical management, and were randomized in a prospective study of anoscopic treatments to heater versus bipolar probes. Failure was defined as a major complication or failure to reduce the size of all internal hemorrhoids with three or more treatments. RESULTS With similar background variables and no difference in treatment times, rectal bleeding and other symptoms were controlled in a shorter time with the heater probe than with the bipolar probe (77 versus 121 days). Five complications (fissures, bleeding, or rectal spasm) occurred with the bipolar probe, and two occurred with the heater probe. The heater probe caused more pain during treatments but had significantly fewer failures and crossovers. CONCLUSIONS For patients who had failed medical management of chronically bleeding internal hemorrhoids, the techniques and complications of heater and bipolar probes were similar, but pain was more common, failures and crossovers were less frequent, and the time to symptom relief was shorter with the heater probe than with the bipolar probe.

3575 Randomized controlled study of combination epinephrine injection and gold probe compared to gold probe alone for hemostasis of actively bleeding peptic ulcers.

The treatment of high risk patients with non-bleeding adherent clots (CLOTS) on ulcers is a controversy. In a previous RCT, there was no benefit to endoscopic injection or heater probe compared to medical therapy for prevention of recurrent ulcer hemorrhage. The purpose of this study is to test the hypothesis that patients treated with endoscopic combination therapy of CLOTS would have significantly lower rebleeding rates than those treated with medical therapy alone. Methods. In this RCT, 31 elderly patients with co-morbid conditions, severe ulcer hemorrhage, and endoscopic non-bleeding CLOTS resistent to target irrigation were randomized to medical therapy alone (PPIs BID, transfusions, and correction of coagulopathies)and sham endoscopic therapy (washing but no contact or endoscopic treatment) or to combination therapy with epinephrine injection (1:10,000, 4 quadrant in 1 cc aliquots), shaving down the CLOT with cold guillotining (snare without cautery), bipolar coagulation (Gold probe, 15- 20W, 10 sec pulses, firm tamponade) on the underlying stigmata and medical therapy. Physicians blinded to the endoscopic therapy managed all patients. Results. Patients were similar at study entry, except for older age and higher rates of NSAID or aspirin ingestion before their hemorrhage in the medical group. See table for details. By the time of discharge, significantly more medical patients-4/15 (26.7%)-than endoscopically treated patients-0/16 (0%)-rebled (p=0.027). There were no complications of the combination treatment. Conclusions: 1) Combination endoscopic therapy (epinephrine injection, cold guillotining to reveal stigmata and GP coagulation) and medical treatment of non-bleeding CLOTS significantly reduced early rebleeding rates in high risk patients compared to medical therapy alone. 2) This endoscopic treatment was safe. Funded by NIH DK33273 and partially by Microvasive-Boston Scientific.

3576 Randomized, prospective study of bipolar coagulation alone compared to combination epinephrine injection and bipolar coagulation for prevention of rebleeding from ulcers with nonbleeding visible vessels.

BACKGROUND PURPOSES (1) to prospectively evaluate efficacy and safety of direct current (DC) probe treatment of chronic anal fissures associated with internal hemorrhoids, and (2) to estimate direct and indirect costs of anoscopic treatment versus surgery. METHODS Ten patients with chronic fissures of 11 mm (mean length) had symptoms for 5 months (mean) in spite of medical management; all had internal hemorrhoidal disease. DC coagulation was applied to two or three contiguous internal hemorrhoids per outpatient session. Eleven mA (mean) of DC current was delivered for 7 minutes (mean) per hemorrhoid segment. RESULTS All 10 patients had relief of chronic anal pain within two treatments and nine anal fissures healed within 4 weeks. One patient developed a perianal abscess and fistula requiring surgery. There were no recurrences in 20 months (mean) of follow-up with medical management. Mean direct and indirect costs (in terms of lost time from work or usual activity) of DC probe treatments were estimated to be 10% to 30% lower and 2 to 10 times less, respectively, than standard surgery for chronic anal fissures. CONCLUSION DC probe treatment for chronic anal fissures associated with internal hemorrhoidal disease is an important advance as an effective, safe, and cost-effective nonsurgical treatment in selected patients.

A randomized prospective study of endoscopic bipolar electrocoagulation and heater probe treatment of chronic rectal bleeding from radiation telangiectasia

tO be similar in both groups, i.e. 271100 (27.0%) in the LAN30 and 25192 (27.2%) in the LAN15 group. Of these 192 patients, 9 were not available for the estimation of the endoscopic relapse rate (6 stopped the trial prematurely without any indication of endoscopic relapse and 3 had no 1-year endoscopy). The endoscopic relapse rate after 1 year was also found to be similar in both groups, i.e. 21/94 (22.3%) in the LAN30 and 21189 (23.6%) in the LAN15 group. However, further analysis revealed that the previous episode of acute reflux oesophagitis had been more severe in the LAN30 than in the LAN15 group (p=0.024) and that a positive correlation existed between the grade of previous reflux oesophagitis and endoscopic relapse (p < 0.05). For the more severe oesophagitis grades (IJI-IV) endoscopic relapse rate was slightly lower in the LAN30 than in the LAN15 group i.e. 8•34 (23.5%) versus 5/17 (29.4%), but this was not of statistical significance. The number of patients with an adverse experience was also similar in both groups and no serious adverse experiences related to the trial medication were encountered. Conclusion 30mg and 15rag were equally effective, so 15rag once a day appears to be sufficient in the maintenance treatment of reflux oesophagitis with lansoprazole. This research was funded in collaboration by Hoechst Marion Roussel, Hoevelaken, and Janssen-Cilag B.V., Tilburg, The Netherlands.

The economic impact of esophageal variceal hemorrhage: Cost‐effectiveness implications of endoscopic therapy

Control of arterial bleeding from peptic uclers is a challenging clinical problem. Our purposes were to compare 1) effectiveness and safety of combination epinephrine injection (EPI) and bipolar coagulation (COMBO) vs. bipolar coagulation alone for hemostasis of actively bleeding peptic ulcers and 2) effectiveness of a new inject-Gold probe catheter. Methods: This is a multicenter, randomized, blinded study of high risk patients with clinically severe hemorrhage and active, arterial type bleeding from gastric or duodenal ulcers at emergency endoscopy. Patients with oozing bleeding were excluded. Patients were randomly assigned to endoscopic treatment with COMBO (injection in 4 quadrants of 1:10,000 EPI and Gold probe coagulation-10F, 15-20W, firm tamponade & 10 sec pulses) or bipolar alone (Gold probe-GP-without EPI). If bleeding could not be controlled within 15 min of endoscopic therapy, patients were classified as a failure and crossed over or sent to surgery. Patients were managed by a separate team of physicians who were blinded to the endoscopic treatment type. All patients received PPIs BID. Results: 36 pts (19 GP & 17 COMBO) were randomized. The two groups were similar at study entry except that signficantly more COMBO pts were ingesting NSAIDs (41% vs 11%) and the mean baseline Hcts were higher (26 vs. 22) than the GP group. See table for results. Primary hemostasis rate was significantly higher with COMBO. There were no deaths or complications. Inject-GP was rated by all investigators as faster and more convenient than a separate injection needle and GP. Conclusions. For bleeding ulcers with active arterial hemorrhage: 1) There were significantly higher rates of initial hemostasis with combination injection and bipolar coagulation than bipolar alone. 2) The new inject- Gold probe was rated by endoscopists as faster and more convenient than separate catheters. Funded by NIH DK33273 and partially by Microvasive-Boston Scientific.