Duodenal Ulcer BleedingNCT01471496
Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers
A study testing prophylactic injection therapy in people with Duodenal Ulcer Bleeding, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether prophylactic injection therapy reduces recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent bleeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Duodenal Ulcer Bleeding
- What is being tested?
- prophylactic injection therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2003to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Endoscopic diagnose of Forrest type 2b duodenal ulcer.
Who cannot join
- Patients at whom the onset of Upper Gastrointestinal system bleeding symptoms exceeded 24 hours at index endoscopy.
- Patients having hemodynamic instability: systolic blood pressure below 90 mm/hg, heart rate above 110/min
- Demonstration of hemoglobin fall more than 2 g/dl in two hours.
- Patients with coexisting ulcers elsewhere than in duodenum.
- Patients under anticoagulant therapy other than Aspirin.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery
Istanbul, 34147
About this study
Official title: Prophylactic Injection Therapy Reduces Recurrent Bleeding Rate In Forrest Type IIb Duodenal Ulcer Bleeding
The purpose of this study is to determine whether prophylactic injection therapy reduces recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent bleeding.
Read the detailed description
The benefit of endoscopic therapy in ulcers with adherent clots on their surface is still uncertain. A prophylactic injection therapy may reduce the recurrent bleeding rate at this group of patients having this endoscopic stigma of recent bleeding. This type of ulcers are named as type IIb duodenal ulcers according to Forrest's classification, They cary the risk of bleeding recurrence up to 36 percent and as it is reported previously there may be a 12 fold increasement in morbidity and mortality in such cases. A prophylactic endoscopic injection therapy may reduce the risk of recurrent bleeding in this group of the patients.
- Conditions
- Duodenal Ulcer Bleeding
- Being tested
- prophylactic injection therapy
- Keywords
- duodenal ulcer, upper gastrointestinal system bleeding, injection therapy
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic injection therapyProcedure or surgery
Also called prophylactic sclerotherapy
Standard application of endoscopic injection therapy as it is used for actively bleeding ulcers, 10 ml of serum saline with 1/10000 epinephrine is submucosally injected to the four quadrants of the ulcer margins.
| Study group | Role | What they receive |
|---|---|---|
| prophylactic injection therapy group | Experimental | In addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy. Receives: Procedure: prophylactic injection therapy |
| control group | No intervention | This group of the patients recieved medical therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.
Measured: within first two days after index endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startJan 2003
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Duodenal Ulcer BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Osman Z Öner, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471496
- Sponsor's protocol ID
- konuk-001
- Status last verified
- Nov 2011
- First submitted
- 1 Nov 2011
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheung FK, Lau JY. Management of massive peptic ulcer bleeding. Gastroenterol Clin North Am. 2009 Jun;38(2):231-43. doi: 10.1016/j.gtc.2009.03.003.
PubMed 19446256Enestvedt BK, Gralnek IM, Mattek N, Lieberman DA, Eisen G. An evaluation of endoscopic indications and findings related to nonvariceal upper-GI hemorrhage in a large multicenter consortium. Gastrointest Endosc. 2008 Mar;67(3):422-9. doi: 10.1016/j.gie.2007.09.024. Epub 2008 Jan 18.
PubMed 18206878Yavorski RT, Wong RK, Maydonovitch C, Battin LS, Furnia A, Amundson DE. Analysis of 3,294 cases of upper gastrointestinal bleeding in military medical facilities. Am J Gastroenterol. 1995 Apr;90(4):568-73.
PubMed 7717312Pilotto A, Maggi S, Noale M, Franceschi M, Parisi G, Crepaldi G; IPOD Investigators. Development and validation of a new questionnaire for the evaluation of upper gastrointestinal symptoms in the elderly population: a multicenter study. J Gerontol A Biol Sci Med Sci. 2010 Feb;65(2):174-8. doi: 10.1093/gerona/glp073. Epub 2009 Jun 15.
PubMed 19528359Cappell MS, Friedel D. Initial management of acute upper gastrointestinal bleeding: from initial evaluation up to gastrointestinal endoscopy. Med Clin North Am. 2008 May;92(3):491-509, xi. doi: 10.1016/j.mcna.2008.01.005.
PubMed 18387374Kovacs TO. Management of upper gastrointestinal bleeding. Curr Gastroenterol Rep. 2008 Dec;10(6):535-42. doi: 10.1007/s11894-008-0099-3.
PubMed 19006607Kubba AK, Palmer KR. Role of endoscopic injection therapy in the treatment of bleeding peptic ulcer. Br J Surg. 1996 Apr;83(4):461-8. doi: 10.1002/bjs.1800830408.
PubMed 8665233Chung SC, Leung JW, Leung FW. Effect of submucosal epinephrine injection on local gastric blood flow. A study using laser Doppler flowmetry and reflectance spectrophotometry. Dig Dis Sci. 1990 Aug;35(8):1008-11. doi: 10.1007/BF01537250.
PubMed 2384031Calvet X, Vergara M, Brullet E, Gisbert JP, Campo R. Addition of a second endoscopic treatment following epinephrine injection improves outcome in high-risk bleeding ulcers. Gastroenterology. 2004 Feb;126(2):441-50. doi: 10.1053/j.gastro.2003.11.006.
PubMed 14762781Green FW Jr, Kaplan MM, Curtis LE, Levine PH. Effect of acid and pepsin on blood coagulation and platelet aggregation. A possible contributor prolonged gastroduodenal mucosal hemorrhage. Gastroenterology. 1978 Jan;74(1):38-43.
PubMed 21830Heldwein W, Schreiner J, Pedrazzoli J, Lehnert P. Is the Forrest classification a useful tool for planning endoscopic therapy of bleeding peptic ulcers? Endoscopy. 1989 Nov;21(6):258-62. doi: 10.1055/s-2007-1010729.
PubMed 2693077Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available.
PubMed 16457402Forrest 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.
PubMed 4136718Peter S, Wilcox CM. Modern endoscopic therapy of peptic ulcer bleeding. Dig Dis. 2008;26(4):291-9. doi: 10.1159/000177011. Epub 2009 Jan 30.
PubMed 19188717Armstrong CP, Blower AL. Non-steroidal anti-inflammatory drugs and life threatening complications of peptic ulceration. Gut. 1987 May;28(5):527-32. doi: 10.1136/gut.28.5.527.
PubMed 3596334
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Injection Therapy Reduces Recurrent Bleeding Rate In Forrest Type IIb Duodenal Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT01471496
- Acronym / sponsor ID
- konuk-001
- Conditions
- Duodenal Ulcer Bleeding
- Keywords
- duodenal ulcer, upper gastrointestinal system bleeding, injection therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Jan 2003
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether prophylactic injection therapy reduces recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent bleeding.
Detailed description
The benefit of endoscopic therapy in ulcers with adherent clots on their surface is still uncertain. A prophylactic injection therapy may reduce the recurrent bleeding rate at this group of patients having this endoscopic stigma of recent bleeding. This type of ulcers are named as type IIb duodenal ulcers according to Forrest's classification, They cary the risk of bleeding recurrence up to 36 percent and as it is reported previously there may be a 12 fold increasement in morbidity and mortality in such cases. A prophylactic endoscopic injection therapy may reduce the risk of recurrent bleeding in this group of the patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic injection therapy group | Experimental | Procedure: prophylactic injection therapyIn addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy. |
| control group | No intervention | –This group of the patients recieved medical therapy only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopic diagnose of Forrest type 2b duodenal ulcer.
Key exclusion criteria (5 listed)
- Patients at whom the onset of Upper Gastrointestinal system bleeding symptoms exceeded 24 hours at index endoscopy.
- Patients having hemodynamic instability: systolic blood pressure below 90 mm/hg, heart rate above 110/min
- Demonstration of hemoglobin fall more than 2 g/dl in two hours.
- Patients with coexisting ulcers elsewhere than in duodenum.
- Patients under anticoagulant therapy other than Aspirin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylactic injection therapyAlso: prophylactic sclerotherapyStandard application of endoscopic injection therapy as it is used for actively bleeding ulcers, 10 ml of serum saline with 1/10000 epinephrine is submucosally injected to the four quadrants of the ulcer margins. | Procedure or surgery | prophylactic injection therapy group |
Primary outcome
Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.
Time frame: within first two days after index endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
- Background: PubMed 19446256Cheung FK, Lau JY. Management of massive peptic ulcer bleeding. Gastroenterol Clin North Am. 2009 Jun;38(2):231-43. doi: 10.1016/j.gtc.2009.03.003.
- Background: PubMed 18206878Enestvedt BK, Gralnek IM, Mattek N, Lieberman DA, Eisen G. An evaluation of endoscopic indications and findings related to nonvariceal upper-GI hemorrhage in a large multicenter consortium. Gastrointest Endosc. 2008 Mar;67(3):422-9. doi: 10.1016/j.gie.2007.09.024. Epub 2008 Jan 18.
- Background: PubMed 7717312Yavorski RT, Wong RK, Maydonovitch C, Battin LS, Furnia A, Amundson DE. Analysis of 3,294 cases of upper gastrointestinal bleeding in military medical facilities. Am J Gastroenterol. 1995 Apr;90(4):568-73.
- Background: PubMed 19528359Pilotto A, Maggi S, Noale M, Franceschi M, Parisi G, Crepaldi G; IPOD Investigators. Development and validation of a new questionnaire for the evaluation of upper gastrointestinal symptoms in the elderly population: a multicenter study. J Gerontol A Biol Sci Med Sci. 2010 Feb;65(2):174-8. doi: 10.1093/gerona/glp073. Epub 2009 Jun 15.
- Background: PubMed 18387374Cappell MS, Friedel D. Initial management of acute upper gastrointestinal bleeding: from initial evaluation up to gastrointestinal endoscopy. Med Clin North Am. 2008 May;92(3):491-509, xi. doi: 10.1016/j.mcna.2008.01.005.
- Background: PubMed 19006607Kovacs TO. Management of upper gastrointestinal bleeding. Curr Gastroenterol Rep. 2008 Dec;10(6):535-42. doi: 10.1007/s11894-008-0099-3.
- Background: PubMed 8665233Kubba AK, Palmer KR. Role of endoscopic injection therapy in the treatment of bleeding peptic ulcer. Br J Surg. 1996 Apr;83(4):461-8. doi: 10.1002/bjs.1800830408.
- Background: PubMed 2384031Chung SC, Leung JW, Leung FW. Effect of submucosal epinephrine injection on local gastric blood flow. A study using laser Doppler flowmetry and reflectance spectrophotometry. Dig Dis Sci. 1990 Aug;35(8):1008-11. doi: 10.1007/BF01537250.
- Background: PubMed 14762781Calvet X, Vergara M, Brullet E, Gisbert JP, Campo R. Addition of a second endoscopic treatment following epinephrine injection improves outcome in high-risk bleeding ulcers. Gastroenterology. 2004 Feb;126(2):441-50. doi: 10.1053/j.gastro.2003.11.006.
- Background: PubMed 21830Green FW Jr, Kaplan MM, Curtis LE, Levine PH. Effect of acid and pepsin on blood coagulation and platelet aggregation. A possible contributor prolonged gastroduodenal mucosal hemorrhage. Gastroenterology. 1978 Jan;74(1):38-43.
- Background: PubMed 2693077Heldwein W, Schreiner J, Pedrazzoli J, Lehnert P. Is the Forrest classification a useful tool for planning endoscopic therapy of bleeding peptic ulcers? Endoscopy. 1989 Nov;21(6):258-62. doi: 10.1055/s-2007-1010729.
- Background: PubMed 16457402Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman Z Öner, MD principal investigator
Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic injection therapy in people with Duodenal Ulcer Bleeding, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery. (time frame: within first two days after index endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471496, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.