Elimination of Peritoneal Tumor Cells With Extensive Peritoneal Lavage During Surgery in Patients With Gastric Cancer

NCT01476553 | Terminated

• 1 other identifier: UMM-EIPL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Japanese study showed that the additional use of an "Extensive Intraperitoneal Lavage" (EIPL), i.e. an extensive washing of the abdominal cavity with water, during surgery for gastric cancer can lead to a significant increase in survival. However, the study was confined to patients in whom upon commencing surgery, free peritoneal tumor cells were detected, which is only a small fraction of patients. The primary objective of our study is to assess in all patients undergoing removal of the stomach and adjacent lymph nodes for stomach cancer, if EIPL can eliminate free peritoneal tumor cells which have been present at the beginning of the surgery or after the stomach and lymph node removal. Secondary objectives are to assess how often free peritoneal tumor cells occur in patients with stomach cancer, how often surgical resection itself leads to a release of tumor cells, the safety of the EIPL procedure, and disease-free and overall survival of patients undergoing EIPL. Based on the outcome of this japanese study we want to test with special laboratory methods why this lavage leads to a better outcome. Specifically, the trial will test the hypotheses that a) lymph node dissection causes a release of tumor cells in the abdominal cavity, and b) EIPL eliminates free peritoneal tumor cells.

Conditions

Adenocarcinoma; Stomach Neoplasms

Keywords

gastric cancer; extensive intraperitoneal lavage; EIPL; intraperitoneal tumor cells; peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Peritoneal Conversion Rate (PCR)

  The Peritoneal Conversion Rate (PCR) is defined as the proportion of patients in whom no free peritoneal tumor cells are detected after EIPL among all patients in whom free peritoneal tumor cells were detected before EIPL. In other words, the PCR measures in what proportion of patients EIPL leads to an elimination of intraperitoneal tumor cells.

  intraoperative (day of surgery)

Secondary Outcomes (5)

• Peritoneal Release Rate (PRR)

  intraoperative (day of surgery)

• Prevalence of free peritoneal tumor cells before resection

  intraoperative (day of surgery)

• Overall Survival

  up to 3 years

• Recurrence-free survival

  up to 3 years

• Perioperative in-hospital morbidity

  up to the end of the hospital stay (estimated average two weeks after surgery)

Study Arms (1)

Intervention arm

EXPERIMENTAL

Extensive Intraperitoneal Lavage (EIPL)

Procedure: Extensive Intraperitoneal Lavage (EIPL)

Interventions

Extensive Intraperitoneal Lavage (EIPL) PROCEDURE

EIPL is performed after completing resection and lymphadenectomy: the abdominal cavity has to be washed ten times with one liter Ringer's solution. Each liter has to be well dispersed manually in the abdominal cavity, and removed and disposed completely. 100 ml of the last liter of lavage fluid will be harvested and sent for analysis. Contrary to the Japanese trial, Ringer's solution will be used instead of normal saline solution because of a presumed higher likelihood of peritoneal adhesions when employing the latter (7). Ringer's solution is the standard used for all intraperitoneal lavage procedures at the study centre. To avoid hypothermia, the lavage fluid will be warmed to body temperature (37° Celsius).

Also known as: EIPL, extensive intraperitoneal lavage, lavage

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adenocarcinoma of the stomach or cardia (Siewert Type 2 or 3), treated in curative intent with a gastrectomy or subtotal gastrectomy, and D2 lymphadenectomy.

You may not qualify if:

• Written informed consent
• Age ≥ 18 years
• Histologically proven peritoneal carcinomatosis (biopsies of macroscopically suspicious findings must be taken at the beginning of the operation and be analyzed immediately by fresh frozen section)
• Histologically proven distant metastases
• Other medical causes precluding EIPL (e.g. critical condition throughout the surgery with the need to terminate the operation as soon as possible)

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead
• Heidelberg University: collaborator

Study Sites (1)

University Hospital Mannheim, Department of Surgery

Mannheim, 68167, Germany

Location

Related Publications (8)

• Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.

  PMID: 20409751 BACKGROUND

• Okines A, Verheij M, Allum W, Cunningham D, Cervantes A; ESMO Guidelines Working Group. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v50-4. doi: 10.1093/annonc/mdq164. No abstract available.

  PMID: 20555102 BACKGROUND

• Marutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85.

  PMID: 12576435 BACKGROUND

• Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Yagi Y, Matsuda M, Yonemura Y, Baba H. Extensive intraoperative peritoneal lavage as a standard prophylactic strategy for peritoneal recurrence in patients with gastric carcinoma. Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e.

  PMID: 19638909 BACKGROUND

• Shimada S, Tanaka E, Marutsuka T, Honmyo U, Tokunaga H, Yagi Y, Aoki N, Ogawa M. Extensive intraoperative peritoneal lavage and chemotherapy for gastric cancer patients with peritoneal free cancer cells. Gastric Cancer. 2002;5(3):168-72. doi: 10.1007/s101200200029.

  PMID: 12378344 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Breborowicz A, Oreopoulos DG. Is normal saline harmful to the peritoneum? Perit Dial Int. 2005 Apr;25 Suppl 4:S67-70.

  PMID: 16300274 BACKGROUND

• Ronellenfitsch U, Ernst K, Mertens C, Trunk MJ, Strobel P, Marx A, Kienle P, Post S, Nowak K. Extensive intraperitoneal lavage to eliminate intraperitoneal tumor cells in gastrectomy with D2 lymphadenectomy for gastric cancer. Tumori. 2018 Oct;104(5):361-368. doi: 10.1177/0300891618792485. Epub 2018 Sep 5.

  PMID: 30185117 DERIVED

MeSH Terms

Conditions

Adenocarcinoma; Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Ulrich Ronellenfitsch, MD

  University Hospital Mannheim, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 22, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

DE (1)