Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

Peptic Ulcer Hemorrhage Clinical Trial

— HETUB  

Official title:

Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00687336
• Other study ID #: CIR2007/058
• Status: Recruiting
• Phase: Phase 4
• First received: May 27, 2008
• Last updated: July 7, 2009
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2009
• Source: Hospital de Sabadell
• Contact: Pilar Garcia, Dra.
• Phone: 34-93-723-1010
• Email: pgarciai[@]telefonica.net
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18.

• Informed Consent signed.

• Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.

• Life expectancy longer than 6 months.

• Able to attend further clinical controls.

• Absence of the following exclusion criteria.

Exclusion Criteria:

• Previous eradication treatment.

• Use of antibiotics 2 weeks prior to inclusion.

• Need for Antisecretor treatment that cannot be stopped to perform the breath test.

• Pregnancy or breastfeeding.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Other:
• Empirical Hp eradication
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
• Eradication treatment guided by a positive test
Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.

Locations

Country	Name	City	State
Spain	Hospital de Sabadell, Institut Universitari Parc Tauli	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Sabadell	Centro de Investigación Biomédica en Red, Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (22)

Calam J. Helicobacter pylori. Eur J Clin Invest. 1994 Aug;24(8):501-10. Review. — View Citation

Castro-Fernández M, Sánchez-Muñoz D, García-Díaz E, Miralles-Sanchiz J, Vargas-Romero J. Diagnosis of Helicobacter pylori infection in patients with bleeding ulcer disease: rapid urease test and histology. Rev Esp Enferm Dig. 2004 Jun;96(6):395-8; 398-401. English, Spanish. — View Citation

Coghlan JG, Gilligan D, Humphries H, McKenna D, Dooley C, Sweeney E, Keane C, O'Morain C. Campylobacter pylori and recurrence of duodenal ulcers--a 12-month follow-up study. Lancet. 1987 Nov 14;2(8568):1109-11. — View Citation

García-Altés A, Jovell AJ, Serra-Prat M, Aymerich M. Management of Helicobacter pylori in duodenal ulcer: a cost-effectiveness analysis. Aliment Pharmacol Ther. 2000 Dec;14(12):1631-8. — 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. Epub 2006 Feb 22. Review. — View Citation

Gisbert JP, Blanco M, Mateos JM, Fernández-Salazar L, Fernández-Bermejo M, Cantero J, Pajares JM. H. pylori-negative duodenal ulcer prevalence and causes in 774 patients. Dig Dis Sci. 1999 Nov;44(11):2295-302. — View Citation

Gisbert JP, Boixeda D, Aller R, de la Serna C, Sanz E, Martín de Argila C, Abraira V, García Plaza A. [Helicobacter pylori and digestive hemorrhage due to duodenal ulcer: the prevalence of the infection, the efficacy of 3 triple therapies and the role of eradication in preventing a hemorrhagic recurrence]. Med Clin (Barc). 1999 Feb 13;112(5):161-5. Spanish. — View Citation

Gisbert JP, Calvet X, Gomollón F, Monés J; Grupo Conferencia Española de Consenso sobre Helicobacter pylori. [Eradication treatment of Helicobacter pylori. Recommendations of the II Spanish Consensus Conference]. Med Clin (Barc). 2005 Sep 10;125(8):301-16. Review. Spanish. — View Citation

Gisbert JP, Gonzalez L, de Pedro A, Valbuena M, Prieto B, Llorca I, Briz R, Khorrami S, Garcia-Gravalos R, Pajares JM. Helicobacter pylori and bleeding duodenal ulcer: prevalence of the infection and role of non-steroidal anti-inflammatory drugs. Scand J Gastroenterol. 2001 Jul;36(7):717-24. — View Citation

Graham DY, Hepps KS, Ramirez FC, Lew GM, Saeed ZA. Treatment of Helicobacter pylori reduces the rate of rebleeding in peptic ulcer disease. Scand J Gastroenterol. 1993 Nov;28(11):939-42. — View Citation

Güell M, Artigau E, Esteve V, Sánchez-Delgado J, Junquera F, Calvet X. Usefulness of a delayed test for the diagnosis of Helicobacter pylori infection in bleeding peptic ulcer. Aliment Pharmacol Ther. 2006 Jan 1;23(1):53-9. — View Citation

Houghton J, Wang TC. Helicobacter pylori and gastric cancer: a new paradigm for inflammation-associated epithelial cancers. Gastroenterology. 2005 May;128(6):1567-78. Review. — View Citation

Kuipers EJ, Thijs JC, Festen HP. The prevalence of Helicobacter pylori in peptic ulcer disease. Aliment Pharmacol Ther. 1995;9 Suppl 2:59-69. Review. — View Citation

Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. Review. — View Citation

Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. Review. — View Citation

Macri G, Milani S, Surrenti E, Passaleva MT, Salvadori G, Surrenti C. Eradication of Helicobacter pylori reduces the rate of duodenal ulcer rebleeding: a long-term follow-up study. Am J Gastroenterol. 1998 Jun;93(6):925-7. — View Citation

Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ, Phillips M, Waters TE, Sanderson CR. Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori. Lancet. 1988 Dec 24-31;2(8626-8627):1437-42. — View Citation

Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet. 1984 Jun 16;1(8390):1311-5. — View Citation

Pellicano R, Peyre S, Leone N, Repici A, De Angelis C, Rizzi R, Rizzetto M, Ponzetto A. The effect of the eradication of Helicobacter pylori infection on hemorrhage because of duodenal ulcer. J Clin Gastroenterol. 2001 Mar;32(3):222-4. — 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. — View Citation

Soll AH, Weinstein WM, Kurata J, McCarthy D. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991 Feb 15;114(4):307-19. Review. — View Citation

Sung JJ, Leung WK, Suen R, Leung VK, Chan FK, Ling TK, Lau JY, Lee YT, Ng EK, Cheng AF, Chung SC. One-week antibiotics versus maintenance acid suppression therapy for Helicobacter pylori-associated peptic ulcer bleeding. Dig Dis Sci. 1997 Dec;42(12):2524-8. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate		two years	No
Secondary	Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.		two years	No