*Baylor College of Medicine, The Elkins Pancreas Center, Michael E. DeBakey Department of Surgery, and The Dan L. Duncan Cancer Center, Houston, TX †Department of Surgery, The Ohio State University, Columbus, OH ‡Department of Surgery, University of Florida, Gainesville, FL §Department of Surgery, Jefferson Medical College, Philadelphia, PA ¶Department of Surgery, Baptist Memorial Hospital/The University of Tennessee Health Science Center, Memphis, TN ‖Department of Surgery, Indiana University, Indianapolis, IN **Department of Surgery, University of Pennsylvania, Philadelphia, PA ††Department of Surgery, University of South Florida, Tampa, FL; and ‡‡Department of Surgery, The University of Texas Medical Branch, Galveston, TX.
Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460.
To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications.
Some surgeons have abandoned the use of drains placed during pancreas resection.
We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups.
There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage.
This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.
通过随机前瞻性多中心试验检验以下假设，即不使用腹腔引流的胰十二指肠切除术（PD）不会增加并发症的频率或严重程度。
一些外科医生已放弃在胰腺切除术中使用引流管。
我们将 137 名患者随机分为 PD 组（n = 68，引流组）和非 PD 组（n = 69，无引流组），比较了这两种方法的安全性和并发症谱。
引流组和无引流组在人口统计学、合并症、病理学、胰管大小、胰腺质地、基线生活质量或手术技术方面无差异。与 PD 联合腹腔引流相比，PD 不联合腹腔引流增加了每位患者的并发症数量[1（0-2）比 2（1-4），P = 0.029]；增加了至少有 1 例≥2 级并发症的患者数量[35（52%）比 47（68%），P = 0.047]；以及更高的平均并发症严重程度[2（0-2）比 2（1-3），P = 0.027]。PD 不联合腹腔引流与胃轻瘫、腹腔积液、腹腔脓肿（10%比 25%，P = 0.027）、严重（≥2 级）腹泻、需要术后经皮引流以及住院时间延长的发生率更高有关。数据安全监测委员会因 PD 患者中无腹腔引流组的死亡率从 3%增加到 12%而提前停止了该研究。
本研究提供了 1 级数据，表明在所有 PD 病例中消除腹腔引流会增加并发症的频率和严重程度。
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