The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma
Study Details
Study Description
Brief Summary
SUMMARY
Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. It is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment.
Objective: To determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma.
Study design: Multicentre retrospective cohort study.
Study population: All Patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (MDT) between January 2016 and December 2018.
Intervention (if applicable): Not applicable.
Main study parameters/endpoints: The main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a DL and CT response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is an observational study, no burden or risks are associated with participation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Change in treatment [1 month (on average)]
Proportion of patients in which the diagnostic test led to change in treatment/management
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histologically proven gastric and esophagogastric junction adenocarcinoma.
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Patients who have had (either) DLS and/or CT response assessment (after chemotherapy).
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Discussed at MDT from January 2016 - December 2018
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≥18 years
Exclusion Criteria:
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Patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation;
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Patients with recurrent/residual disease after earlier treatment of gastric cancer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus MC | Rotterdam | Netherlands |
Sponsors and Collaborators
- Sander van Hootegem
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEC-2019-0284