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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013775
• Other study ID #: MEC-2019-0284
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: May 12, 2021

Study information

• Verified date: August 2021
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: May 12, 2021
• Est. primary completion date: August 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

Intervention

Diagnostic Test:
• Computed tomography
Computed tomography to gauge response after preoperative chemotherapy cycles and excluded the development of interval metastases or irresectable disease
• Diagnostic laparoscopy with peritoneal lavage
Diagnostic laparoscopy lavage to exclude (small-volume) metastases and determine local resectability

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Sander van Hootegem

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in treatment	Proportion of patients in which the diagnostic test led to change in treatment/management	1 month (on average)