A peptide-first hemostatic strategy for oozing-type postsphincterotomy bleeding during endoscopic retrograde cholangiopancreatography: a multicenter noninferiority randomized controlled trial (PROTECT-EST) - 18/07/26
, Tsukasa Ikeura, MD, PhD 4, Mamoru Takenaka, MD, PhD 5, Daiki Fumihara, MD 6, Nobu Nishioka, MD, PhD 1, 2, Saori Onda, MD, PhD 1, 2, Takafumi Kanadani, MD 1, 2, Yoshitaro Yamamoto, MD, PhD 1, 2, Kimi Bessho, MD 1, 2, Nobuhiro Hattori, MD 1, 2, Shinji Nakayama, MD, PhD 4, Takashi Ito, MD, PhD 4, Koh Nakamaru, MD, PhD 4, Masataka Masuda, MD, PhD 4, Ayaka Takaori, MD, PhD 4, Tomohiro Fukunaga, MD, PhD 5, Masayuki Kurimoto, MD, PhD 5, Toshiyuki Morisawa, MD, PhD 6, Keisuke Furumatsu, MD, PhD 6, Akitoshi Hakoda, MD, PhD 1Abstract |
Background and Aims |
Immediate bleeding after endoscopic sphincterotomy (EST) is a common adverse event during ERCP. However, the optimal first-line hemostatic strategy remains undefined because comparative randomized trials are lacking. We aimed to evaluate the noninferiority of a self-assembling peptide (SAP)–first strategy compared with conventional balloon tamponade for oozing-type immediate post-EST bleeding, with superiority testing performed as a prespecified exploratory analysis.
Methods |
PROTECT-EST (A peptide-first hemostatic strategy for oozing-type postsphincterotomy bleeding during endoscopic retrograde cholangiopancreatography: a multicenter noninferiority randomized controlled trial) was a multicenter, investigator-initiated, parallel-group randomized controlled trial conducted at tertiary referral centers in Japan. Adults with oozing-type bleeding persisting for ≥180 seconds after EST without spontaneous hemostasis were randomly assigned (1:1) to SAP application or balloon tamponade as the initial hemostatic strategy. The primary end point was successful initial hemostasis, defined as the absence of active oozing for ≥3 minutes after the assigned intervention. Noninferiority was tested first, and superiority was assessed as a prespecified exploratory analysis.
Results |
A total of 130 patients were randomized (SAP group, n = 65; balloon group, n = 65). SAP met the prespecified noninferiority criterion. In the prespecified exploratory superiority analysis, successful initial hemostasis occurred in 60 of 65 patients (92.3%) in the SAP group and 50 of 65 patients (76.9%) in the balloon group (risk difference, 15.4 percentage points; 95% CI, 3.1-27.7; P = .027). The mean time to completion of the initial hemostatic intervention was shorter in the SAP group, and rescue hemostatic devices were required less frequently (7.7% vs 23.1%; P = .033). Adverse events and delayed hemorrhage were similar between groups. In supportive bootstrap-based economic analyses, the SAP-first strategy was generally more effective and not more costly.
Conclusions |
In this noninferiority trial, a SAP-first strategy was noninferior to balloon tamponade for oozing-type immediate post-EST bleeding and, in exploratory analyses, was associated with higher initial hemostasis, shorter procedure time, and less rescue device use. SAP may represent a practical first-line option, although external validation is warranted.
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Abbreviations : ASGE, CSEMS, EST, INR, OR, PT, SAP, USD
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