Korean J Gastroenterol.  2015 Aug;66(2):85-91. 10.4166/kjg.2015.66.2.85.

Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?

• Lee SH
• Jung JT
• Lee DW
• Ha CY
• Park KS
• Lee SH
• Yang CH
• Park YS
• Jeon SW

• KMID: 2373319
• DOI: http://doi.org/10.4166/kjg.2015.66.2.85

Abstract

BACKGROUND/AIMS
Endoscopic hemoclip application is an effective and safe method of endoscopic hemostasis. We conducted a multicenter retrospective study on hemoclip and hemoclip combination therapy based on prospective cohort database in terms of hemostatic efficacy not in clinical trial but in real clinical practice.
METHODS
Data on endoscopic hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB) were prospectively collected from February 2011 to December 2013. Among 1,584 patients with NVUGIB, 186 patients treated with hemoclip were enrolled in this study. Subjects were divided into three groups: Group 1 (n=62), hemoclipping only; group 2 (n=88), hemoclipping plus epinephrine injection; and group 3 (n=36), hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. Primary outcomes included rebleeding, other therapeutic management, hospitalization period, fasting period and mortality. Secondary outcomes were bleeding associated mortality and overall mortality.
RESULTS
Active bleeding and peptic ulcer bleeding were more common in group 3 than in group 1 and in group 2 (p<0.001). However, primary outcomes (rebleeding, other management, morbidity, hospitalization period, fasting period and mortality) and secondary outcomes (bleeding associated mortality and total mortality) were not different among groups.
CONCLUSIONS
Combination therapy of epinephrine injection and other modalities with hemoclips did not show advantage over hemoclipping alone in this prospective cohort study. However, there is a tendency to perform combination therapy in active bleeding which resulted in equivalent hemostatic success rate, and this reflects the role of combination therapy in clinical practice.

Keyword

Gastrointestinal hemorrhage; Endoscopic hemostasis

MeSH Terms

Adult
Aged
Angiography
Cohort Studies
Combined Modality Therapy
Databases, Factual
Epinephrine/therapeutic use
Female
Gastrointestinal Hemorrhage/etiology/*therapy
*Hemostasis, Endoscopic
Humans
Male
Middle Aged
Prospective Studies
Proton Pump Inhibitors/therapeutic use
Retrospective Studies
Stomach Ulcer/complications/drug therapy/pathology
Surgical Instruments
Treatment Outcome
Epinephrine
Proton Pump Inhibitors

Figure

• 

  Fig. 1. Overall schema of patient enrollment. Group 1, treated by hemoclipping only; group 2, treated by hemoclipping plus epinephrine injection; group 3, treated by hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. NVUGIB, non-variceal upper gastrointestinal bleeding; Plt, platelet.

Reference

References

1. Yuan Y, Wang C, Hunt RH. Endoscopic clipping for acute non-variceal upper-GI bleeding: a metaanalysis and critical appraisal of randomized controlled trials. Gastrointest Endosc. 2008; 68:339–351.

2. Sung JJ, Tsoi KK, Lai LH, Wu JC, Lau JY. Endoscopic clipping versus injection and thermo-coagulation in the treatment of non-variceal upper gastrointestinal bleeding: a metaanalysis. Gut. 2007; 56:1364–1373.

3. Gevers AM, De Goede E, Simoens M, Hiele M, Rutgeerts P. A randomized trial comparing injection therapy with hemoclip and with injection combined with hemoclip for bleeding ulcers. Gastrointest Endosc. 2002; 55:466–469.

4. Shimoda R, Iwakiri R, Sakata H, et al. Evaluation of endoscopic hemostasis with metallic hemoclips for bleeding gastric ulcer: comparison with endoscopic injection of absolute ethanol in a prospective, randomized study. Am J Gastroenterol. 2003; 98:2198–2202.

5. Chung IK, Ham JS, Kim HS, Park SH, Lee MH, Kim SJ. Comparison of the hemostatic efficacy of the endoscopic hemoclip method with hypertonic saline-epinephrine injection and a combination of the two for the management of bleeding peptic ulcers. Gastrointest Endosc. 1999; 49:13–18.

6. Hahn OM, Schilsky RL. Randomized controlled trials and comparative effectiveness research. J Clin Oncol. 2012; 30:4194–4201.

7. Brass EP. The gap between clinical trials and clinical practice: the use of pragmatic clinical trials to inform regulatory decision making. Clin Pharmacol Ther. 2010; 87:351–355.

8. Davidson MH. Differences between clinical trial efficacy and re-al-world effectiveness. Am J Manag Care. 2006; 12(15 Suppl):S405–S411.

9. Chung IK. How can we maximize skills for non-variceal upper gastrointestinal bleeding: injection, clipping, burning, or others? Clin Endosc. 2012; 45:230–234.

10. Barkun AN, Bardou M, Kuipers EJ, et al. International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010; 152:101–113.

11. Park CH, Joo YE, Kim HS, Choi SK, Rew JS, Kim SJ. A prospective, randomized trial comparing mechanical methods of hemostasis plus epinephrine injection to epinephrine injection alone for bleeding peptic ulcer. Gastrointest Endosc. 2004; 60:173–179.

12. Lo CC, Hsu PI, Lo GH, et al. Comparison of hemostatic efficacy for epinephrine injection alone and injection combined with hemoclip therapy in treating high-risk bleeding ulcers. Gastrointest Endosc. 2006; 63:767–773.

13. Barkun A, Bardou M, Marshall JK. Nonvariceal Upper GI Bleeding Consensus Conference Group. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2003; 139:843–857.

14. Barkun AN, Martel M, Toubouti Y, Rahme E, Bardou M. Endoscopic hemostasis in peptic ulcer bleeding for patients with high-risk lesions: a series of meta-analyses. Gastrointest Endosc. 2009; 69:786–799.

15. Laine L, McQuaid KR. Endoscopic therapy for bleeding ulcers: an evidence-based approach based on meta-analyses of randomized controlled trials. Clin Gastroenterol Hepatol. 2009; 7:33–47. quiz 1–2.

16. Marmo R, Rotondano G, Piscopo R, Bianco MA, D'Angella R, Cipolletta L. Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a metaanalysis of controlled trials. Am J Gastroenterol. 2007; 102:279–289. quiz 469.

17. Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996; 38:316–321.

18. Chen IC, Hung MS, Chiu TF, Chen JC, Hsiao CT. Risk scoring systems to predict need for clinical intervention for patients with nonvariceal upper gastrointestinal tract bleeding. Am J Emerg Med. 2007; 25:774–779.