Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT00935779

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasm

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Ultra Structure of Peritoneum at Electronic Microscopy in Control Subjects and Patients With Gastric Cancer

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Jul 1, 2004

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Gastric cancer patients with operable local gastric adenocarcinoma were studied
Control group patients operated on for benign diseases served as controls, randomly selected among patients with chronic gastro-esophageal reflux disease who were considered good candidates for antireflux surgery and properly matched in sex and age to study group

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Clinical Hospital, University of Chile	Santiago	Region Metropolitana	Chile

Sponsors and Collaborators

University of Chile

Investigators

Principal Investigator: Patricio Burdiles, MD, Department of Surgery, Clinical Hospital, University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00935779

Other Study ID Numbers:

OAIC 043/02

First Posted:

Jul 9, 2009

Last Update Posted:

Jul 9, 2009

Last Verified:

Jul 1, 2009

Keywords provided by , ,

Stomach Neoplasms

Peritoneum

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Jul 9, 2009