Matsumoto Mio, Kato Mototsugu, Oba Koji, Abiko Satoshi, Tsuda Momoko, Miyamoto Shuichi, Mizushima Takeshi, Ono Masayoshi, Omori Saori, Takahashi Masakazu, Ono Shoko, Mabe Katsuhiro, Nakagawa Manabu, Nakagawa Soichi, Kudo Takahiko, Shimizu Yuichi, Sakamoto Naoya
Department of Gastroenterology, Sapporo Medical Center NTT EC, Sapporo, Japan.
Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan.
Dig Endosc. 2016 Jul;28(5):570-6. doi: 10.1111/den.12661. Epub 2016 May 25.
Prophylactic clipping has been widely used to prevent post-procedural bleeding in colon polypctomy. However, its efficiency has not been confirmed and there is no consensus on the usefulness of prophylactic clipping. The aim of the present study was to evaluate the preventive effect of prophylactic clipping on post-polypectomy bleeding.
A multicenter randomized controlled study was conducted from January 2012 to July 2013 in Japan. Patients who had polyps <2 cm in diameter were divided into a clipping group and a non-clipping group by cluster randomization. After endoscopic polypectomy, patients allocated to the clipping group underwent prophylactic clipping, whereas the procedure was completed without clipping in patients allocated to the non-clipping group. Occurrence of post-polypectomy bleeding was compared between the two groups.
Seven hospitals participated in this study. A total of 3365 polyps in 1499 patients were evaluated. The clipping group consisted of 1636 polyps in 752 patients, and the non-clipping group consisted of 1729 polyps in 747 patients. Post-polypectomy bleeding occurred in 1.10% (18/1636) of the cases in the clipping group, and in 0.87% (15/1729) of those in the non-clipping group. The difference was -0.22% (95% confidence interval [CI]: -0.96, 0.53). Upper limit of the 95% CI was lower than the non-inferiority margin (1.5%), and we could thus prove non-inferiority of non-clipping against clipping.
Prophylactic clipping is not necessary to prevent post-polypectomy bleeding for polyps <2 cm in diameter.
预防性钳夹术已广泛用于预防结肠息肉切除术后出血。然而，其有效性尚未得到证实，对于预防性钳夹术的实用性也未达成共识。本研究的目的是评估预防性钳夹术对息肉切除术后出血的预防效果。
2012年1月至2013年7月在日本进行了一项多中心随机对照研究。将直径<2 cm的息肉患者通过整群随机化分为钳夹组和非钳夹组。内镜下息肉切除术后，分配到钳夹组的患者接受预防性钳夹，而分配到非钳夹组的患者在不进行钳夹的情况下完成手术。比较两组息肉切除术后出血的发生率。
七家医院参与了本研究。共评估了1499例患者的3365个息肉。钳夹组包括752例患者的1636个息肉，非钳夹组包括747例患者的1729个息肉。钳夹组1.10%（18/1636）的病例发生了息肉切除术后出血，非钳夹组为0.87%（15/1729）。差异为-0.22%（95%置信区间[CI]：-0.96，0.53）。95%CI的上限低于非劣效界值（1.5%），因此我们可以证明非钳夹术相对于钳夹术的非劣效性。
对于直径<2 cm的息肉，预防性钳夹术并非预防息肉切除术后出血所必需。
