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Completed

NCT Number: NCT01471496

Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers

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.

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Key information

Conditions

Duodenal Ulcer Bleeding Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Department of General Surgery

Istanbul, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endoscopic diagnose of Forrest type 2b duodenal ulcer.

Exclusion criteria

  • 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.

Treatment and study plan

prophylactic injection therapy

Procedure

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.

Other names: prophylactic sclerotherapy

Primary outcomes

  1. Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.

    Time frame: within first two days after index endoscopy

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Prophylactic Injection Therapy Reduces Recurrent Bleeding Rate In Forrest Type IIb Duodenal Ulcer Bleeding

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 15, 2011
Registry last updated
Nov 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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