Department of Oncology, University of Milan, Milan, Italy.
Hepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Ann Surg. 2019 Nov;270(5):791-798. doi: 10.1097/SLA.0000000000003514.
The aim of this study was to assess safety and efficacy of pancreatic duct occlusion (PDO) with neoprene-based glue in selected patients undergoing pancreatoduodenectomy (PD) at high risk of postoperative pancreatic fistula (POPF).
PD is the reference standard approach for tumors of the pancreaticoduodenal region. POPF is the most relevant complication after PD. PDO has been proposed as an alternative to anastomosis to manage the pancreatic stump.
A single-center, prospective, nonrandomized trial enrolled 100 consecutive PD for cancer. Patients at high risk for POPF according to Fistula Risk Score (FRS) >15% (≥6 points) were treated with PDO using neoprene glue (study cohort); patients with FRS ≤15% (≤5 points) received pancreaticojejunal anastomosis (PJA: control cohort). Primary endpoint was complication rate grade ≥3 according to Dindo-Clavien Classification (DCC). Other postoperative outcomes were monitored (ClinicalTrials.gov NCT03738787).
Fifty-one patients underwent PDO and 49 PJA. DCC ≥3, postoperative mortality, and POPF grade B-C were 25.5% versus 24.5% (P = 0.91), 5.9% versus 2% (P = 0.62), and 11.8% versus 16.3% (P = 0.51) in the study versus control cohort, respectively. At 1 and 3 years, new-onset diabetes was diagnosed in 13.7% and 36.7% of the study cohort versu 4.2% and 12.2% in controls (P = 0.007).
PDO with neoprene-based glue is a safe technique that equalizes early outcome of selected patients at high risk of POPF to those at low risk undergoing PJA. Neoprene-based PDO, however, triples the risk of diabetes at 1 and 3 years.
本研究旨在评估在接受胰十二指肠切除术（PD）的高危患者中使用氯丁基胶进行胰管阻塞（PDO）的安全性和疗效，这些患者术后发生胰瘘（POPF）的风险较高。
PD 是胰十二指肠区域肿瘤的标准治疗方法。POPF 是 PD 后最相关的并发症。PDO 已被提议作为吻合术的替代方法来处理胰腺残端。
一项单中心、前瞻性、非随机试验纳入了 100 例连续的癌症 PD 患者。根据 Fistula Risk Score（FRS）>15%（≥6 分），高危发生 POPF 的患者接受氯丁基胶 PDO 治疗（研究组）；FRS≤15%（≤5 分）的患者接受胰肠吻合术（PJA：对照组）。主要终点是根据 Dindo-Clavien 分类（DCC）≥3 级的并发症发生率。监测其他术后结果（ClinicalTrials.gov NCT03738787）。
51 例患者接受 PDO，49 例患者接受 PJA。DCC≥3 级、术后死亡率和 POPF 分级 B-C 的发生率在研究组和对照组分别为 25.5%与 24.5%（P=0.91）、5.9%与 2%（P=0.62）、11.8%与 16.3%（P=0.51）。在研究组中，1 年和 3 年时新诊断的糖尿病发生率分别为 13.7%和 36.7%，而对照组分别为 4.2%和 12.2%（P=0.007）。
使用氯丁基胶的 PDO 是一种安全的技术，可使高危 POPF 患者的早期结果与接受 PJA 的低危患者相均衡。然而，氯丁基胶的 PDO 使 1 年和 3 年时糖尿病的风险增加了两倍。
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