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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00935779
Other study ID # OAIC 043/02
Secondary ID
Status Completed
Phase N/A
First received July 7, 2009
Last updated July 8, 2009
Start date October 2002
Est. completion date December 2004

Study information

Verified date July 2009
Source University of Chile
Contact n/a
Is FDA regulated No
Health authority Chile: Instituto de Salud Pública de Chile
Study type Observational

Clinical Trial Summary

Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.


Description:

18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with operable local gastric adenocarcinoma

Exclusion Criteria:

- previous abdominal surgery

- previous open or blunt abdominal trauma

- history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.

- All other gastric malignancies such as lymphomas, GIST, carcinoids

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Chile Department of Surgery, Clinical Hospital, University of Chile Santiago Region Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

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