title: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery/Oncology, Faculdade Pernambucana de Saúde, Instituto de Medicina Integral Professor Fernando Figueira (FPS/IMIP), Recife, PE, Brasil.
authors.forename: Thales Paulo
authors.initials: TP
authors.lastname: Batista
authors.affiliation: Department of Abdominal Surgery, Hospital de Câncer de Pernambuco (HCP), Recife, PE, Brasil.
authors.forename: Mário Rino
authors.initials: MR
authors.lastname: Martins
authors.affiliation: Department of General Surgery, FPS/IMIP, Recife, PE, Brasil.
authors.forename: Euclides Dias
authors.initials: ED
authors.lastname: Martins-Filho
authors.affiliation: Department of Abdominal Surgery, Hospital de Câncer de Pernambuco (HCP), Recife, PE, Brasil.
authors.forename: Rogerio Luiz Dos
authors.initials: RL
authors.lastname: Santos
mesh_terms: D000328:Adult; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010533:Peritoneal Lavage; D010534:Peritoneal Neoplasms / Q000517:prevention & control* / Q000556:secondary; D011184:Postoperative Period; D012008:Recurrence; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*