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

NCT05013775 | Completed

• 1 other identifier: MEC-2019-0284
• Study Type: observational
• Target: 697
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in treatment

  Proportion of patients in which the diagnostic test led to change in treatment/management

  1 month (on average)

Interventions

Computed tomography DIAGNOSTIC_TEST

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_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with gastric and gastro-oesophageal adenocarcinoma who presented or were referred to one of the participating centres and have been discussed at multidisciplinary team meetings (MDT) for curative management from January 2016 through December 2018. The University Medical Center of the Johannes Gutenberg University Mainz will only contribute with data on DL and not on patients who underwent CT response assessment.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sander van Hootegem: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Tomography, X-Ray Computed; Laparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 19, 2021
• Study Start: January 15, 2019
• Primary Completion: August 22, 2020
• Study Completion: May 12, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

NL (1)