Third, endoscopic high risk stigmata are frequently discovered at the second endoscopy and this observation is often used to justify repeat endoscopic therapy; however, the natural history of these lesions after therapy has already been applied is unknown. A randomized trial addresses the above problems, allowing known and unknown con-founders to be balanced, and allows the natural history of residual high risk stigmata to be documented. Therefore, the remainder of the discussion focuses on randomized trials.
There have been six randomized trials of second look endoscopy , including two that were published in abstract form only. Of these studies, four (Table 1) showed that a routine second look endoscopy is not effective for reducing rebleeding rates or other adverse outcomes. One of the two positive studies was published only in abstract form several years ago. The other had a sample size of only 20 patients in each treatment arm.
The earliest randomized trial was published by Villanueva et al. A total of 104 patients was randomized, after initial injection therapy with epinephrine, to either a second procedure at 18 h to 24 h with retreatment if persistent high risk stigmata were found, or a repeat endoscopy only if there were signs of clinical rebleeding. Rebleeding rates were 21% with second look endoscopy compared with 29% in the conservative group. There was also a trend toward a higher rate of surgery in the conservative group (8% versus 15%).
TABLE 1 Summary of the four full-manuscript randomized trials
|Control (%)||Second look (%)||Control (%)||Second look (%)||Control (%)||Second look (%)|
|Villanueva et al||104||29||21||15||8||4||2||18% rebled early*59% had high risk stigmata on second scope 45% versus 36% rebleeding in high and low risk stratification on second endoscopy|
|Saeed et al||40||24||0t||NA||NA||10||5||70% active bleeders 0% rebled early*84% had high risk stigmata on second scope High proportion of late rebleeders (40%)|
|Rutgeerts et al||536||19*||15||5*||3||5*||4||Three-arm study of polidocanol versus fibrin glue versus repeated fibrin glue|
|Messmann et al||105||17||21||4||6||4||6||29% rebled early*19% had high risk stigmata on second scope 21% of bleeds were in patients with low risk at second endoscopy|
“Early’implies that bleeding occurred before second look endoscopy was arranged; <0.05; *Fibrin glue arm. NA Not available