Status:
TERMINATED
Elimination of Peritoneal Tumor Cells With Extensive Peritoneal Lavage During Surgery in Patients With Gastric Cancer
Lead Sponsor:
Universitätsmedizin Mannheim
Collaborating Sponsors:
Heidelberg University
Conditions:
Adenocarcinoma
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 lea...
Detailed Description
In spite of the existence of multimodal therapy, the long-term survival of patients with gastric cancer remains poor. In advanced tumor stages, five-year survival rates rarely exceed 30%. One of the f...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the stomach or cardia (Siewert Type 2 or 3), treated in curative intent with a gastrectomy or subtotal gastrectomy, and D2 lymphadenectomy.
- Adjuvant and neoadjuvant therapy do not constitute exclusion criteria
- Written informed consent
- Age ≥ 18 years
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01476553
Start Date
February 1 2011
End Date
March 1 2013
Last Update
May 2 2017
Active Locations (1)
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1
University Hospital Mannheim, Department of Surgery
Mannheim, Germany, 68167