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

NCT ID: NCT05013775

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 697 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-05-12

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.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Computed tomography

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

Intervention Type: DIAGNOSTIC_TEST

Diagnostic laparoscopy with peritoneal lavage

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sander van Hootegem

OTHER

Sponsor Role: lead

Responsible Party

Sander van Hootegem

Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

MEC-2019-0284

Identifier Type: -

Identifier Source: org_study_id