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JOURNAL CLUB. 14 April 2003. Background. Pt has post-op UGI bleed Resuscitated, IV omeprazole Urgent endoscopy reveals bleeding DU Injected, bleeding controlled PPI continued Pt recovers. Background. Do they need CLO testing or urease breath testing?
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JOURNAL CLUB 14 April 2003
Background • Pt has post-op UGI bleed • Resuscitated, IV omeprazole • Urgent endoscopy reveals bleeding DU • Injected, bleeding controlled • PPI continued • Pt recovers
Background • Do they need CLO testing or urease breath testing? • Should the patient be commenced on triple therapy or just PPI? • What about other acute peptic ulcer presentations?
The Question • What is the role of Helicobacter pylori eradication in the management of acute peptic ulcer bleeding/perforation?
In search of the answer … • Medline (1996 – current) • Keywords – Helicobacter pylori, peptic ulcer haemorrhage, peptic ulcer perforation • Limit search to human studies and English • Limit search to RCT • Yield – 9 for bleeding , 3 for perforation
In search of the answer … • Unanimous opinion regarding treatment of bleeding peptic ulcers – eradicate H. pylori • NIH Consensus Statement 1994 • Maastricht Consensus Report 1997 • RCT’s for perforation and eradication • Indian J Gastroenterol, BJS, Ann Surg
Overview • Aim – to evaluate effect of H. pylori eradication on ulcer recurrence after perforation and simple repair • Method – pts confirmed H. pylori positive randomised to anti-helicobacter therapy or PPI therapy only • Outcome measure – Initial ulcer healing and recurrence at 1 year
Study protocol • All patients with clinical or radiological evidence of perforated DU included • Ethics approval, informed consent • Exclusion criteria • Age <16, >75; pregnancy • Antibiotic or PPI use <4 weeks prior • Previous gastric surgery • Perforation whilst being treated for other illness • Sealed-off perforation
Study protocol • Pts appropriately treated for perforated DU • Intra-op gastroscopy performed and 7 biopsies taken • CLO (x1), Micro (x3), Histo (x3) • Operative procedure • Omental patch unless large ulcer (>1cm) • IV antibiotics and PPI for 3 days
Study protocol • Only H. pylori-positive patients randomised • Eradication group • 1 week course bismuth, tetracycline, metronidazole • 4 weeks omeprazole • Control group • 4 weeks omeprazole • Compliance by telephone and tablet count
Study protocol – Outcome assessment • Endoscopy at 8 weeks • Biopsies for H. pylori status • Interview 3 monthly • Re-scoped if symptomatic • Non-healed ulcers at 8 weeks treated with further 4 weeks of PPI and re-scope at 16 weeks
Study profile • see Figure 1 • 129 eligible patients • 104 (80.6%) H. pylori positive • 5 intially false neg • 51 treatment, 48 control • 90 presented for 8 week endoscopy
Conclusion • Incidence of H. pylori infection in perforated PU ~80% (104 of 129) • Simple repair of perforated PU known to have high recurrence rate (up to 40%) • Results of this study show good evidence to support eradication of H. pylori in patients presenting with perforated peptic ulcers to reduce recurrence
Strengths of study • Prospective RCT • Well designed • Intention-to-treat analyses • Adequate sample size to fulfill criteria for statistical analysis
Weaknesses of study • Patient sample though adequate for statistical analyses still small • Follow up time relatively short
The answers to our question/s • H. pylori status should be determined when patient recovers • If positive eradication therapy should be commenced with follow-up to check status