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    Top Trials in Gastroenterology & Hepatology
    Top Trials in Gastroenterology & Hepatology
    Top Trials in Gastroenterology & Hepatology
    Ebook147 pages1 hour

    Top Trials in Gastroenterology & Hepatology

    By Mayur Brahmania, Dustin Loomes, Rahul Bhindi and Dana Moffatt

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    About this ebook

    The Top Trials in Gastroenterology and Hepatology is a selection of 25 “hot” trials that have been influential in clinical practice. These trials have been critically appraised and summarized. Topics include:
    - Luminal Gastroenterology
    - Inflammatory Bowel Disease
    - Nutrition
    - Motility
    - Hepatology
    - Therapeutic Endoscopy

    A perspective on each trial gives context and significance to the summaries, and a list of further reading identifies other influential papers.
    - Mayur Brahmania, MD FRCPC, co-author
    - Dustin Loomes, MD FRCPC, co-author
    - Rahul Bhindi, MD, co-author
    - Dana Moffatt, MD FRCPC, co-author

    LanguageEnglish
    PublisherMayur Brahmania
    Release dateAug 4, 2014
    ISBN9781927799055
    Top Trials in Gastroenterology & Hepatology
    Author

    Mayur Brahmania

    Dr. Mayur Brahmania is currently a Gastroenterologist/Hepatologist at the Toronto Western Hospital Liver Centre. Aside from clinical practice, Dr. Brahmania is involved in medical education both at the undergraduate and post-graduate level while also peer reviewing and publishing for many leading gastroenterology and hepatology journals. Dr. Brahmania’s research interests include quality improvement initiatives to advance and standardize quality of care in patients living with liver disease.

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    • 5/5
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    Book preview

    Top Trials in Gastroenterology & Hepatology - Mayur Brahmania

    Preface

    As a learner, it is always challenging to know the background literature that forms the basis of medical knowledge in a specialty, as well as cutting-edge trials on the forefront of clinical practice. This represents a moving target since, with time, new literature is assimilated into conventional wisdom. We made this book to capture a selection of the top trials in the fields of gastroenterology and hepatology. The trials were chosen for their important historical impact and/or for their impact on clinical practice. Included are references to supplemental papers that will enhance knowledge in a given area of practice. Ultimately, we hope this book will serve as a resource for both those interested in gastroenterology as well as those who have chosen gastroenterology as a career.

    Mayur Brahmania, MD FRCPC

    Dustin Loomes, MD FRCPC

    Rahul Bhindi, MD CCFP

    Dana Moffatt, MD FRCPC

    TABLE OF CONTENTS

    Luminal Gastroenterology

    1. Gastrointestinal Bleeding

    2. Colorectal Cancer Screening

    3. Clostridium difficile

    Inflammatory Bowel Disease

    4. Crohn’s Disease

    5. Ulcerative Colitis

    6. Chronic Pouchitis

    Nutrition

    7. Acute Pancreatitis

    8. Intestinal Failure

    9. Bariatric Surgery

    10. Irritable Bowel Syndrome

    11. ICU Nutrition

    Motility

    12. Achalasia

    13. Chronic Constipation

    14. Acute Intestinal Pseudo-Obstruction

    Hepatology

    15. Hepatitis C

    16. Non-Alcoholic Steatohepatitis

    17. Hepatic Encephalopathy

    18. Primary Biliary Cirrhosis

    19. Variceal Bleeding

    20. Spontaneous Bacterial Peritonitis

    21. Alcoholic Hepatitis

    Therapeutic Endoscopy

    22. Barrett’s Esophagus

    23. Post-ERCP Pancreatitis

    24. Chronic Pancreatitis

    25. Infected Pancreatic Necrosis

    LUMINAL GASTROENTEROLOGY

    Chapter 1: Gastrointestinal Bleeding

    Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers

    Lau JY et al. The New England Journal of Medicine. 2000; 343(5):310–316.

    Question

    In patients treated endoscopically for bleeding peptic ulcers, do high-dose IV proton pump inhibitors reduce the frequency of recurrent bleeding compared to placebo?

    Methods

    Design: Randomized controlled

    Blinding: Double-blind

    Follow-up Period: 30 days post randomization

    Setting: Single centre (Hong Kong)

    Funding: Public

    Participants

    Inclusion criteria:

    16 years old or greater

    Successful endoscopic treatment (ie, hemostasis) of actively bleeding ulcers or ulcers with non-bleeding visible vessels

    Exclusion criteria:

    Unsuccessful endoscopic treatment

    Intervention

    240 patients enrolled, with 120 randomly assigned to each group

    After hemostasis achieved (endoscopic epinephrine and thermocoagulation) patients were given omeprazole 80 mg IV bolus, followed by 8 mg/hr infusion for 72 hours, followed by 20 mg PO daily for 2 weeks thereafter.

    Control arm consisted of a placebo bolus and infusion for 72 hours, followed by omeprazole 20 mg PO daily x 2 weeks.

    All patients with positive rapid urease test received a 1-week course of omeprazole 20 mg BID, clarithromycin 500 mg BID, amoxicillin 1 g BID and an additional 7 weeks of omeprazole 20mg PO.

    Outcome

    Primary endpoint:

    Recurrent bleeding within 30 days after endoscopy

    Secondary endpoints:

    Transfusion requirements

    Hospital stay

    Mortality rate

    Rates of surgical intervention

    Results

    Primary endpoint:

    There was less rebleeding (8/120, 6.7%) in treatment group compared with the placebo group (27/120, 22.5%; HR=3.9).

    Most rebleeding occurred during the infusion period (first 3 days), with rebleeding in 5 patients (4.2%) in treatment group vs 24 patients (20.0%; p<0.001) in placebo group.

    Secondary endpoints:

    Smaller mean number of blood units transfused in treatment group (2.7 vs 3.5 units; p=0.04)

    Shorter duration of hospital stay in treatment group for those admitted with a GI bleed (4 days in treatment group vs 5 days in placebo group; p=0.02)

    Trend towards fewer deaths within 30 days of endoscopy in treatment group (5/120, 4.2%) vs placebo group (12/120, 10.0%; p=0.13)

    No significant difference in surgical interventions between the two groups

    Conclusion

    After endoscopic treatment of bleeding peptic ulcers, high-dose IV omeprazole bolus followed by infusion for 72 hrs reduced the rate of recurrent bleeding, the need for endoscopic retreatment, the need for blood transfusions, and shortened the length of hospitalization. There was no significant effect on mortality.

    Perspective

    In vitro studies have suggested that an increased pH (>6) helps to stabilize platelet aggregation and clot formation, as well as decrease clot breakdown by inhibition of pepsin. This trial was pivotal in demonstrating the benefit of omeprazole in decreasing rebleeding rates, transfusions, and length of stay; however, a clear mortality benefit was not shown.

    There are still many unanswered questions: Is high dose PPI better than low dose? Is IV better than PO administration? Are there geographic differences in Asian versus non-Asian populations? An attempt to answer some of these questions in a Cochrane review of 22 RCTs did not show a statistical difference in any of these factors (1). Nevertheless, 72 hours of PPI post-endoscopic hemostasis for high-risk lesions (Forrest Ia, Ib, IIa, and IIb) is now part of routine clinical practice and is recommended by all major societal guidelines.

    Further reading:

    Neumann I et al. Comparison of different regimens of proton pump inhibitors for acute peptic ulcer bleeding.Cochrane database of systematic reviews. 2013; 6:CD007999.

    Omeprazole before endoscopy in patients with gastrointestinal bleeding

    Lau JY et al. The New England Journal of Medicine. 2007; 356(16): 1631–1640.

    Question

    Does giving omeprazole before endoscopy have any effect on the need for endoscopic therapy or improve clinical outcomes?

    Methods

    Design: Randomized controlled

    Blinding: Double-blind

    Follow-up: Day 30 post randomization

    Setting: Single centre (Hong Kong)

    Funding: Public

    Participants

    Inclusion criteria:

    Consecutive patients with overt signs of upper gastrointestinal bleeding

    Exclusion criteria:

    Hypotensive shock refractory to resuscitation

    Age <18

    Unable to consent

    Pregnant

    Allergy to proton pump inhibitors

    Long-term ASA use

    Intervention

    Patients were randomized to omeprazole (n=314) or placebo (n=317) and were given 80 mg IV bolus followed by IV infusion of 8 mg/hr of omeprazole or placebo, respectively, until endoscopy.

    Ulcers with spurting hemorrhage, oozing hemorrhage, or non-bleeding visible vessels were injected with epinephrine (dilution 1:10,000, aliquots of 0.5 to 1 mL) followed by coaptive thermocoagulation.

    Bleeding esophageal and gastric varices were treated by band ligation and injection of cyanoacrylate, respectively, plus vasoactive drugs and IV antibiotics.

    Omeprazole 8 mg/hr IV infusion continued for

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