Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2026
A Multicenter, Single-Blind, Randomized Trial Comparing Stapler Closure With Clip-on-Staple Method Versus Stapler Closure Alone During Distal Pancreatectomy (CLIP-DP Trial).
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Ninomiya Mizuki, Shirabe Ken, Fukuzawa Kengo, Sugimachi Keishi, Soejima Yuji, Maeda Takashi, Yamashita Yo-Ichi, Morine Yuji, Imai Katsunori, Utsunomiya Tohru, Iguchi Tomohiro, Nishizaki Takashi, Matsumoto Toshifumi, Hayashi Hiromitsu, Yamagata Motoyuki, Shimokawa Mototsugu, Yoshizumi Tomoharu
Аннотация
OBJECTIVE: To determine whether the clip-on-staple method reduces clinically relevant postoperative pancreatic fistula (CR-POPF) following distal pancreatectomy (DP).
BACKGROUND: CR-POPF remains the most significant source of morbidity after DP, particularly in patients with thick pancreatic parenchyma. Effective, pragmatic strategies to reduce CR-POPF are needed.
METHODS: The CLIP-DP trial was a multicenter, single-blind, randomized controlled study conducted at 16 Japanese institutions (UMIN000042217). Adults undergoing DP were randomized 1:1 to reinforced stapler closure alone (Arm A) or the clip-on-staple method (Arm B). Allocation employed a central system with minimization method stratified by pancreatic thickness (≤12 mm vs >12 mm), surgical approach, and institution. The primary endpoint was CR-POPF (grade B/C) or death within 30 days. Analyses were prespecified for both the full-analysis set (FAS) and per-protocol set (PPS).
RESULTS: Among 190 randomized patients, 177 were included in the FAS (Arm A, n = 85; Arm B, n = 92) and 170 in the PPS (Arm A, n = 82; Arm B, n = 88). In the FAS, CR-POPF or death occurred in 23.5% of Arm A versus 15.2% of Arm B (P = 0.184, 2-sided α = 0.20). In the PPS, corresponding rates were 24.4% and 12.5% (P = 0.049). Subgroup analysis showed a pronounced reduction in CR-POPF among patients with pancreatic thickness >12 mm (FAS: 32.4% vs 11.9%, P = 0.032; PPS: 32.3% vs 7.5%, P= 0.004). Secondary outcomes and safety profiles were comparable, with no deaths within 90 days.
CONCLUSIONS: The clip-on-staple method reduces CR-POPF after DP compared with stapler closure alone, with the greatest benefit in thick pancreas.
BACKGROUND: CR-POPF remains the most significant source of morbidity after DP, particularly in patients with thick pancreatic parenchyma. Effective, pragmatic strategies to reduce CR-POPF are needed.
METHODS: The CLIP-DP trial was a multicenter, single-blind, randomized controlled study conducted at 16 Japanese institutions (UMIN000042217). Adults undergoing DP were randomized 1:1 to reinforced stapler closure alone (Arm A) or the clip-on-staple method (Arm B). Allocation employed a central system with minimization method stratified by pancreatic thickness (≤12 mm vs >12 mm), surgical approach, and institution. The primary endpoint was CR-POPF (grade B/C) or death within 30 days. Analyses were prespecified for both the full-analysis set (FAS) and per-protocol set (PPS).
RESULTS: Among 190 randomized patients, 177 were included in the FAS (Arm A, n = 85; Arm B, n = 92) and 170 in the PPS (Arm A, n = 82; Arm B, n = 88). In the FAS, CR-POPF or death occurred in 23.5% of Arm A versus 15.2% of Arm B (P = 0.184, 2-sided α = 0.20). In the PPS, corresponding rates were 24.4% and 12.5% (P = 0.049). Subgroup analysis showed a pronounced reduction in CR-POPF among patients with pancreatic thickness >12 mm (FAS: 32.4% vs 11.9%, P = 0.032; PPS: 32.3% vs 7.5%, P= 0.004). Secondary outcomes and safety profiles were comparable, with no deaths within 90 days.
CONCLUSIONS: The clip-on-staple method reduces CR-POPF after DP compared with stapler closure alone, with the greatest benefit in thick pancreas.