Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding

Helicobacter Pylori Infection Clinical Trial

— CIM  

Official title:

Diagnostic Performance of Current Infection Marker (CIM) for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273384
• Other study ID #: Si 062/2023
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Mahidol University
• Contact: Thanapat Atthakitmongkol, MD
• Phone: 66813998583
• Email: ben02170[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:

• To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.

• To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).

• To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT.

Description:

Helicobacter pylori (H. pylori) is a Gram-negative bacillus that involves gastric mucosa and was first isolated in 1982. The global prevalence of H. pylori infection is about 50% and the prevalence is different in each region of the world. The highest prevalence of H. pylori infection is up to 70.1% in Africa, but the prevalence in the South-East Asian region varies from 28.6 to 70.3%. For Thailand, the prevalence of H. pylori infection was reported approximately 43.6-64.0%. H. pylori infection is also well-known to be associated with gastric cancer, Gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and peptic ulcer.

Peptic ulcer strongly associates with H. pylori infection. The global prevalence of H. pylori infection is 48.5-94.5% and 66.9-95.8% in gastric ulcer and duodenal ulcer, respectively. These data corresponded to the prevalence in Thailand which is 68.9% and 82.8 % in gastric ulcers and duodenal ulcers, respectively. Peptic ulcer is also one of the common causes of upper gastrointestinal hemorrhage. In contrast, H. pylori eradication has been shown to reduce the risk of recurrent upper gastrointestinal bleeding.

Nowadays, there are several tests for H. pylori infection including endoscopic-based methods such as rapid urease test (RUT), histopathology, culture, and polymerase chain reaction (PCR) for deoxyribonucleic acid (DNA) of H. pylori detection, and non-invasive methods, including urea breath test (UBT), fecal antigen test, and serologic test. In clinical practice, patients under upper gastrointestinal endoscopy with suspicion of H. pylori infection are almost always tested with RUT and histopathology. Both these methods are simple and available with high sensitivity and specificity that is greater 90 and 95%, respectively.

Patients presented with upper gastrointestinal bleeding are recommended to be diagnosed and treated with endoscopy, if the peptic ulcer including gastric ulcer or duodenal ulcer was found, the H. pylori infection must be considered to test. Blood in the gastric cavity, proton pump inhibitor (PPI), and antibiotic prescription can decrease the sensitivity and specificity of RUT and histopathology. Moreover, the patients with gastric ulcer and duodenal ulcer should be generally treated with PPI for a total duration of 8 to 12 weeks and 4 to 8 weeks, respectively, which could affect the accuracy of RUT for H. pylori detection. Although PCR technique has more than 98% of sensitivity, specificity, and accuracy, it is very expensive test that requires high performance center, so PCR test is not always available and not suitable for clinical practice. Therefore, these limitations can delay the diagnosis of H. pylori infection in patients with upper gastrointestinal hemorrhage, so the patients are also not treated this infection in timely manner.

Serology test for H. pylori infection is the test for blood immunoglobulin G (IgG) detection that has 85% sensitivity and 79% specificity 26. PPI or antibiotic uses and upper gastrointestinal bleeding do not affect to this test, so this method might be a better test for H. pylori infection than the endoscopic-based tests including RUT or histopathology. Currently, the immunochromatographic test is a novel method for H. pylori infection that identify current infection marker (CIM) of H. pylori. It is a simple and rapid test in which the sensitivity and the specificity in general population are 90 - 92.3% and 89 - 90.5%, respectively. However, the use of CIM for H. pylori infection in patients with upper gastrointestinal hemorrhage from peptic ulcer who are treated with PPI or antibiotic has not been done yet.

This study aims to evaluate the efficacy of CIM for H. pylori infection test in patients with upper gastrointestinal hemorrhage from peptic ulcer compared to rapid urease test, histopathology, PCR for H. pylori detection, and UBT method.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy with diagnosis of peptic ulcer

Exclusion Criteria:

• Inappropriate gastric mucosal biopsy conditions such as hemodynamic instability, coagulopathy or severe thrombocytopenia or massive bloody content in gastric cavity or duodenum

• Previous history of gastric surgery such as partial or total gastrectomy

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Hemorrhage
• Infections
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (32)

Banks M, Graham D, Jansen M, Gotoda T, Coda S, di Pietro M, Uedo N, Bhandari P, Pritchard DM, Kuipers EJ, Rodriguez-Justo M, Novelli MR, Ragunath K, Shepherd N, Dinis-Ribeiro M. British Society of Gastroenterology guidelines on the diagnosis and managemen — View Citation

Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.157 — View Citation

Ciociola AA, McSorley DJ, Turner K, Sykes D, Palmer JB. Helicobacter pylori infection rates in duodenal ulcer patients in the United States may be lower than previously estimated. Am J Gastroenterol. 1999 Jul;94(7):1834-40. doi: 10.1111/j.1572-0241.1999.0 — View Citation

FitzGerald R, Smith SM. An Overview of Helicobacter pylori Infection. Methods Mol Biol. 2021;2283:1-14. doi: 10.1007/978-1-0716-1302-3_1. — View Citation

Ford AC, Moayyedi P. Whom should we "test and treat" for Helicobacter pylori? BMJ. 2014 May 20;348:g3320. doi: 10.1136/bmj.g3320. No abstract available. — View Citation

Forrest JA, Finlayson ND, Shearman DJ. Endoscopy in gastrointestinal bleeding. Lancet. 1974 Aug 17;2(7877):394-7. doi: 10.1016/s0140-6736(74)91770-x. No abstract available. — View Citation

Gatta L, Vakil N, Ricci C, Osborn JF, Tampieri A, Perna F, Miglioli M, Vaira D. Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection. Am J Gastroenterol. 2004 May;99(5):823-9. doi: — View Citation

Gisbert JP, Abraira V. Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis. Am J Gastroenterol. 2006 Apr;101(4):848-63. doi: 10.1111/j.1572-0241.2006.00528.x. Epub 2006 Feb 22. — View Citation

Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med. 2008 Aug 28;359(9):928-37. doi: 10.1056/NEJMra0706113. No abstract available. — View Citation

Gralnek IM, Dumonceau JM, Kuipers EJ, Lanas A, Sanders DS, Kurien M, Rotondano G, Hucl T, Dinis-Ribeiro M, Marmo R, Racz I, Arezzo A, Hoffmann RT, Lesur G, de Franchis R, Aabakken L, Veitch A, Radaelli F, Salgueiro P, Cardoso R, Maia L, Zullo A, Cipollett — View Citation

Hentschel E, Brandstatter G, Dragosics B, Hirschl AM, Nemec H, Schutze K, Taufer M, Wurzer H. Effect of ranitidine and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the recurrence of duodenal ulcer. N Engl J Med. 1993 Feb 4; — View Citation

Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 20 — View Citation

Jaspersen D, Koerner T, Schorr W, Brennenstuhl M, Raschka C, Hammar CH. Helicobacter pylori eradication reduces the rate of rebleeding in ulcer hemorrhage. Gastrointest Endosc. 1995 Jan;41(1):5-7. doi: 10.1016/s0016-5107(95)70267-9. — View Citation

Jehanne Q, Benejat L, Megraud F, Bessede E, Lehours P. Evaluation of the Allplex H pylori and ClariR PCR Assay for Helicobacter pylori detection on gastric biopsies. Helicobacter. 2020 Aug;25(4):e12702. doi: 10.1111/hel.12702. Epub 2020 May 19. — View Citation

Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245. Erratum In: Am J Gastroenterol. 2021 Nov 1;116( — View Citation

Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017 Aug 5;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7. Epub 2017 Feb 25. — View Citation

Lee JM, Breslin NP, Fallon C, O'Morain CA. Rapid urease tests lack sensitivity in Helicobacter pylori diagnosis when peptic ulcer disease presents with bleeding. Am J Gastroenterol. 2000 May;95(5):1166-70. doi: 10.1111/j.1572-0241.2000.02004.x. — View Citation

Loy CT, Irwig LM, Katelaris PH, Talley NJ. Do commercial serological kits for Helicobacter pylori infection differ in accuracy? A meta-analysis. Am J Gastroenterol. 1996 Jun;91(6):1138-44. — View Citation

McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available. — View Citation

Moayyedi P. The health economics of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol. 2007;21(2):347-61. doi: 10.1016/j.bpg.2006.11.004. — View Citation

Mohammadian T, Ganji L. The Diagnostic Tests for Detection of Helicobacter pylori Infection. Monoclon Antib Immunodiagn Immunother. 2019 Feb;38(1):1-7. doi: 10.1089/mab.2018.0032. Epub 2019 Jan 16. — View Citation

Patel SK, Pratap CB, Jain AK, Gulati AK, Nath G. Diagnosis of Helicobacter pylori: what should be the gold standard? World J Gastroenterol. 2014 Sep 28;20(36):12847-59. doi: 10.3748/wjg.v20.i36.12847. — View Citation

Pounder RE, Ng D. The prevalence of Helicobacter pylori infection in different countries. Aliment Pharmacol Ther. 1995;9 Suppl 2:33-9. — View Citation

Rahman SH, Azam MG, Rahman MA, Arfin MS, Alam MM, Bhuiyan TM, Ahmed N, Rahman M, Nahar S, Hassan MS. Non-invasive diagnosis of H pylori infection: evaluation of serological tests with and without current infection marker CIM. World J Gastroenterol. 2008 F — View Citation

Rokkas T, Karameris A, Mavrogeorgis A, Rallis E, Giannikos N. Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease. Gastrointest Endosc. 1995 Jan;41(1):1-4. doi: 10.1016/s0016-5107(95)70266-0. — View Citation

Singh V, Mishra S, Rao GR, Jain AK, Dixit VK, Gulati AK, Mahajan D, McClelland M, Nath G. Evaluation of nested PCR in detection of Helicobacter pylori targeting a highly conserved gene: HSP60. Helicobacter. 2008 Feb;13(1):30-4. doi: 10.1111/j.1523-5378.20 — View Citation

Sirinthornpunya S. Prevalence of Helicobacter pylori infection in patients with peptic disease. J Med Assoc Thai. 2012 Mar;95 Suppl 3:S22-7. — View Citation

Tsuji H, Kohli Y, Fukumitsu S, Morita K, Kaneko H, Ohkawara T, Minami M, Ueda K, Sawa Y, Matsuzaki H, Morinaga O, Ohkawara Y. Helicobacter pylori-negative gastric and duodenal ulcers. J Gastroenterol. 1999 Aug;34(4):455-60. doi: 10.1007/s005350050296. — View Citation

Vu C, Ng YY. Prevalence of Helicobacter pylori in peptic ulcer disease in a Singapore hospital. Singapore Med J. 2000 Oct;41(10):478-81. — View Citation

Wang XY, Yang Y, Shi RH, Ho B, Wang HD, Zhang GX. An evaluation of a serologic test with a current infection marker of Helicobacter pylori before and after eradication therapy in Chinese. Helicobacter. 2008 Feb;13(1):49-55. doi: 10.1111/j.1523-5378.2008.0 — View Citation

Warren JR, Marshall B. Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet. 1983 Jun 4;1(8336):1273-5. No abstract available. — View Citation

Zhang W, Liang X, Chen X, Ge Z, Lu H. Time trends in the prevalence of Helicobacter pylori infection in patients with peptic ulcer disease: a single-center retrospective study in Shanghai. J Int Med Res. 2021 Oct;49(10):3000605211051167. doi: 10.1177/0300 — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of CIM method for H. pylori detection	The sensitivity, specificity, and accuracy of the CIM method for H. pylori detection were compared to those of RUT, histopathology, PCR, and UBT.	Through study completion, an average of 2 years
Secondary	The advantages of CIM method for H. pylori detection	The net reclassification index (NRI) of the CIM method for H. pylori detection were compared to those of RUT, histopathology, PCR, and UBT.	Through study completion, an average of 2 years