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Original Investigation
March 27, 2019

Combined Surgery and Extensive Intraoperative Peritoneal Lavage vs Surgery Alone for Treatment of Locally Advanced Gastric Cancer: The SEIPLUS Randomized Clinical Trial

Author Affiliations
  • 1State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
  • 2Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, HeFei, Anhui, China
  • 3Department of General Surgery, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Cancer Hospital, Hefei, Anhui, China
  • 4Department of General Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
  • 5Department of Abdominal Surgery, Jiangxi Provincial Cancer Hospital, Nanchang, Jiangxi, China
  • 6Department of Surgical Oncology, Anqing Municipal Hospital, Anqing, Anhui, China
  • 7Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
  • 8Department of General Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
  • 9Department of Gastrointestinal Surgery, Yuebei People’s Hospital, Shaoguan, Guangdong, China
  • 10Department of General Surgery, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
  • 11Department of General Surgery, Lishui Municipal Central Hospital, Lishui, Zhejiang, China
JAMA Surg. 2019;154(7):610-616. doi:10.1001/jamasurg.2019.0153
Key Points

Question  How do the short-term outcomes following combined surgery and extensive intraoperative peritoneal lavage compare with those of open surgery alone for treatment of locally advanced gastric cancer?

Findings  In this multicenter randomized clinical trial that included 550 adults, the overall postoperative complication rate following surgery alone (17%) was significantly higher than that following combined surgery and lavage (11.1%). Patients receiving surgery plus lavage also exhibited reduced mortality and postoperative pain compared with those receiving surgery alone.

Meaning  Patients may benefit from the addition of extensive intraoperative peritoneal lavage with surgery for treatment of locally advanced gastric cancer.

Abstract

Importance  Peritoneal metastasis is the most frequent pattern of postoperative recurrence in patients with gastric cancer. Extensive intraoperative peritoneal lavage (EIPL) is a new prophylactic strategy for treatment of peritoneal metastasis of locally advanced gastric cancer; however, the safety and efficacy of EIPL is currently unknown.

Objective  To evaluate short-term outcomes of patients with advanced gastric cancer who received combined surgery and EIPL or surgery alone.

Design, Setting, and Participants  From March 2016 to November 2017, 662 patients with advanced gastric cancer receiving D2 gastrectomy were enrolled in a large, multicenter, randomized clinical trial from 11 centers across China. In total, 329 patients were randomly assigned to receive surgery alone, and 333 patients were randomly assigned to receive surgery plus EIPL. Clinical characteristics, operative findings, and postoperative short-term outcomes were compared between the 2 groups in the intent-to-treat population.

Main Outcomes and Measures  Short-term postoperative complications and mortality.

Results  The present analysis included data from 550 patients, 390 men and 160 women, with a mean (SD) age of 60.8 (10.7) years in the surgery alone group and 60.6 (10.8) in the surgery plus EIPL group. Patients assigned to the surgery plus EIPL group exhibited reduced mortality (0 of 279 patients) compared with those assigned to surgery alone (5 of 271 patients [1.9%]) (difference, 1.9%; 95% CI, 0.3%-3.4%; P = .02). A significant difference in the overall postoperative complication rate was observed between patients receiving surgery alone (46 patients [17.0%]) and those receiving surgery plus EIPL (31 patients [11.1%]) (difference, 5.9%; 95% CI, 0.1%-11.6%; P = .04). Postoperative pain occurred more often following surgery alone (48 patients [17.7%]) than following surgery plus EIPL (30 patients [10.8%]) (difference, 7.0%; 95% CI, 0.8%-13.1%; P = .02).

Conclusions and Relevance  Inclusion of EIPL can increase the safety of D2 gastrectomy and decrease postoperative short-term complications and wound pain. As a new, safe, and simple procedure, EIPL therapy is easily performed anywhere and does not require any special devices or techniques. Our study suggests that patients with advanced gastric cancer appear to be candidates for the EIPL approach.

Trial Registration  ClinicalTrials.gov identifier: NCT02745509

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