Purpose <p>Acute necrotic collection (ANC) is an early, local complication of necrotizing pancreatitis, and guidelines recommend a deliberate delay in treating ANC. In patients with early persistent organ failure, such delay may be harmful. This study aimed to assess whether early intervention for ANC confers clinical benefits in this patient population.</p> Methods <p>This is a multicenter, open-label, randomized controlled trial. At 7&#xa0;days after disease onset, patients with ANC and persistent organ failure were screened for: (1) organ failure lasting longer than 7&#xa0;days; (2) organ failure worsening in severity; or (3) new-onset organ failure. If one or more criteria were met, they were randomized to receive either early percutaneous catheter drainage or standard care. The primary outcome was a composite of major complications and/or death during the index admission.</p> Results <p>Overall, 120 patients were randomized to early intervention (<i>N</i> = 63) or standard care (<i>N</i> = 57). There was no difference in the primary composite outcome (33.3% [21/63] versus 36.8% [21/57]; risk difference [RD] − 3.5%; 95% CI, − 20.6 to 13.6%) or the individual components, including mortality. The study groups did not differ in terms of organ failure free days to 21&#xa0;days after randomization (4&#xa0;days [interquartile range 0–14] versus 1&#xa0;day [interquartile range 0–15]). The requirement for minimally invasive debridement and open surgery was comparable between groups.</p> Conclusion <p>Early catheter drainage for ANCs in patients with necrotizing pancreatitis and early persistent organ failure, compared with standard delayed care, did not improve clinical outcomes. Future larger trials are needed to confirm our findings.</p>

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Early versus delayed catheter drainage for patients with necrotizing pancreatitis and early persistent organ failure (TIMING): a multicenter randomized controlled trial

  • Lu Ke,
  • Gang Li,
  • Wenjian Mao,
  • Gordon Doig,
  • Tao Chen,
  • Chao Li,
  • Cheng Qu,
  • Lanting Wang,
  • Lin Gao,
  • Wenhua He,
  • Liang Xia,
  • Feng Guo,
  • Yongjun Lin,
  • Quanxin Feng,
  • Zhiyong Liu,
  • Baiqiang Li,
  • Samir Jaber,
  • Georgios Papachristou,
  • Yin Zhu,
  • Yuxiu Liu,
  • John Windsor,
  • Zhihui Tong,
  • Weiqin Li,
  • Yan Chen,
  • Mingfeng Huang,
  • Jingchun Song,
  • Qingbo Zeng,
  • Weili Gu,
  • Weiwei Chen,
  • Qingcheng Xu,
  • Guobing Chen,
  • Yafei Li,
  • Lijuan Zhao,
  • Songjing Shi,
  • Weijie Yao,
  • Xiaofei Huang,
  • Haibin Ni,
  • Dandan Zhou,
  • Mingzhi Chen,
  • Junli Sun,
  • Keke Xin,
  • Chengjian He,
  • Hongyi Yao,
  • Zigui Zhu,
  • Fang Shao,
  • Yun Zhou,
  • Guixian Luo,
  • Xiaomei Chen,
  • Xiangyang Zhao,
  • Wei Zhao,
  • Long Fu,
  • Shumin Tu,
  • Bing Xue,
  • Xinting Pan,
  • Youdong Wan,
  • Qingyun Zhu,
  • Miao Chen,
  • Kang Li,
  • Hong Mei,
  • Dahuan Li,
  • Lening Ren,
  • Guoxiu Zhang,
  • Min Shao,
  • Dongsheng Zhao,
  • Zhenping Chen,
  • Nonghua Lv,
  • Qiang Li,
  • Honghai Xia,
  • Dongliang Yang,
  • Shusheng Zhou,
  • Weihua Lu,
  • Jingyi Wu,
  • Feng Zhou,
  • Jiyan Lin,
  • Quanxing Feng,
  • Mei Yang,
  • Hong Gao,
  • Shan Xu,
  • Lei Yu,
  • Bin Wu,
  • Huaguang Ye,
  • Jianfeng Tu,
  • Hongguo Yang

摘要

Purpose

Acute necrotic collection (ANC) is an early, local complication of necrotizing pancreatitis, and guidelines recommend a deliberate delay in treating ANC. In patients with early persistent organ failure, such delay may be harmful. This study aimed to assess whether early intervention for ANC confers clinical benefits in this patient population.

Methods

This is a multicenter, open-label, randomized controlled trial. At 7 days after disease onset, patients with ANC and persistent organ failure were screened for: (1) organ failure lasting longer than 7 days; (2) organ failure worsening in severity; or (3) new-onset organ failure. If one or more criteria were met, they were randomized to receive either early percutaneous catheter drainage or standard care. The primary outcome was a composite of major complications and/or death during the index admission.

Results

Overall, 120 patients were randomized to early intervention (N = 63) or standard care (N = 57). There was no difference in the primary composite outcome (33.3% [21/63] versus 36.8% [21/57]; risk difference [RD] − 3.5%; 95% CI, − 20.6 to 13.6%) or the individual components, including mortality. The study groups did not differ in terms of organ failure free days to 21 days after randomization (4 days [interquartile range 0–14] versus 1 day [interquartile range 0–15]). The requirement for minimally invasive debridement and open surgery was comparable between groups.

Conclusion

Early catheter drainage for ANCs in patients with necrotizing pancreatitis and early persistent organ failure, compared with standard delayed care, did not improve clinical outcomes. Future larger trials are needed to confirm our findings.