A PHASE II TRIAL EXPLORING THE EXTENSIVE INTRA-OPERATIVE PERITONEAL LAVAGE (EIPL) AS A PROPHYLACTIC STRATEGY FOR PERITONEAL RECURRENCE IN LOCALLY ADVANCED GASTRIC CANCER: reporting postoperative morbidity and mortality after early closure

Abstract

-Background -The Extensive Intraoperative Peritoneal Lavage (EIPL) has been proposed as a practical prophylactic strategy to decrease the risk of peritoneal metastasis in gastric cancer. Objective -To explore the safety and efficacy of the EIPL in our locally advanced gastric cancer patients. Methods -This study is an open-label, double-center, single-arm phase II clinical trial developed at two tertiary hospitals from Recife (Pernambuco, Brazil). Results -The study protocol was prematurely closed due to slow accrual after only 16 patients had been recruited to participate. Eight of them were excluded of the protocol study during the laparotomy, whereas four cases were also excluded from the per-protocol analysis. Two patients had died in hospital before 30 days and six were alive with no evidence of cancer relapses after a follow-up ranging from five to 14,2 months (median of 10.6 months). In the intention-to-treat analysis, three of eight patients suffered of gastrointestinal leakages and two of them had died. On a per-protocol basis, two of four patients presented this type of postoperative complication and one of them had died. All deaths occurred as a somewhat consequence of gastrointestinal leakages. Conclusion -We could not make any conclusion about the safety and efficacy of the EIPL, but the possibility of this approach might increase the rate of gastrointestinal leakage is highlighted. HEADINGS -Stomach neoplasms. Lymph node excision. Local neoplasm recurrence.Declared conflict of interest of all authors: none Disclosure of funding: no funding received

Extensive intraperitoneal lavage to eliminate intraperitoneal tumor cells in gastrectomy with D2 lymphadenectomy for gastric cancer

“…This is an argument in favor of the procedural safety of EIPL and does not support the assumption of a higher risk of morbidity, and particularly of anastomotic or duodenal stump leakage, which was brought up by a Brazilian trial. 13…”

Effect of World Health Organization (WHO) Histological Classification on Predicting Lymph Node Metastasis and Recurrence in Early Gastric Cancer

“…Recurrence in EGC causes treatment failure and leads to 13.7–23% of all related deaths [ 12 , 13 ]. However, independent predictors for recurrence in EGC have not been well studied because of the low recurrence rate [ 6 , 8 , 10 , 11 ].…”

Combination of Surgery With Extensive Intraoperative Peritoneal Lavage for Patients With Advanced Gastric Cancer

“…In our own experience, a study was prematurely closed owing to slow accrual after only 8 patients had been allocated to EIPL protocol. In our intent-to-treat analysis, 3 of 8 patients experienced gastrointestinal leakages, and 2 of them had died as a somewhat consequence of leakages . Herein, the possibility of this approach might increase the rate of gastrointestinal leakage was highlighted, but we could not make a definitive conclusion about the safety and efficacy of the EIPL.…”

“…Despite the initial enthusiasm with the reported decreasing of postoperative short-term complications, mortality, and wound pain, I would like to add some criticism to this issue in light of previous experiences . First, the authors present some arguments for explaining their unexpected results, but the evidences for supporting their favorable findings are lacking.…”