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The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma

The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05013775
Enrollment
697
Registered
2021-08-19
Start date
2019-01-15
Completion date
2021-05-12
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

DIAGNOSTIC_TESTComputed tomography

Computed tomography to gauge response after preoperative chemotherapy cycles and excluded the development of interval metastases or irresectable disease

DIAGNOSTIC_TESTDiagnostic laparoscopy with peritoneal lavage

Diagnostic laparoscopy lavage to exclude (small-volume) metastases and determine local resectability

Sponsors

Sander van Hootegem
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with histologically proven gastric and esophagogastric junction adenocarcinoma. * Patients who have had (either) DLS and/or CT response assessment (after chemotherapy). * Discussed at MDT from January 2016 - December 2018 * ≥18 years

Exclusion criteria

* Patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation; * Patients with recurrent/residual disease after earlier treatment of gastric cancer.

Design outcomes

Primary

MeasureTime frameDescription
Change in treatment1 month (on average)Proportion of patients in which the diagnostic test led to change in treatment/management

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026