title: Endoscopic versus operative treatment in high-risk ulcer bleeding patients - results of a randomised study.
abstract: OBJECTIVE
  The treatment of peptic ulcer bleeding is still a matter of controversy in high-risk patients with arterial bleeding or a visible vessel. Patients with recurrent bleeding during hospital stay carry an increased risk of death. Therapeutic concepts using early elective operation compete with solitary endoscopic treatment. Numerous prospective studies have contrasted comparable improvements for the different therapeutic regimens but there is still a lack of a randomised comparison.
  
  
  METHODS
  We initiated a multicentre randomised clinical trial comparing endoscopic fibrin glue injection with early elective operation in peptic ulcer patients with arterial bleeding or a visible vessel > or =2 mm. After initial endoscopic control of bleeding, patients were randomised to repeated fibrin glue injection or early elective operation. Outcome criteria were recurrent bleeding and death. The study was terminated after a planned interim analysis.
  
  
  RESULTS
  Due to strict inclusion and exclusion criteria 61 patients were randomised and 55 patients could be included in the per-protocol analysis, 23 in the early elective operation group and 32 in the patient group with endoscopic therapy. The type of surgery in the early elective operation group was usually gastric resection (79%). Recurrent bleeding occurred in 50% of the endoscopically treated patient group, and in the operative group in one patient (relative risk: 11.5; 95% CI: 1.6 to 80.7). There were no statistically significant differences between the two treatment groups with respect to mortality (relative risk: 0.7, 95% CI: 0.1 to 4.8).
  
  
  CONCLUSIONS
  Early elective surgery is an effective procedure in bleeding peptic ulcer patients at high risk for re-bleeding. Fibrin glue injection carries a risk for re-bleeding, however, the majority of these re-bleeding episodes can be controlled by re-endoscopic treatment, but a subgroup will need an emergency operation with a fatal outcome in individual patients.
authors.affiliation: Department of General and Trauma Surgery, St.-Vinzenz Hospital, Düsseldorf, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Imhof
authors.forename: Christian
authors.initials: C
authors.lastname: Ohmann
authors.forename: Hans-Dietrich
authors.initials: HD
authors.lastname: Röher
authors.forename: Holger
authors.initials: H
authors.lastname: Glutig
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005743:Gastrectomy / Q000379:methods*; D005773:Gastroscopy / Q000379:methods; D016558:Hemostasis, Endoscopic / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000175:diagnosis* / Q000601:surgery / Q000628:therapy*; D011183:Postoperative Complications; D012008:Recurrence; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D015718:Fibrin Tissue Adhesive