Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Zurich
Information provided by (Responsible Party):
Kuno Lehmann, University of Zurich Identifier:
First received: November 28, 2008
Last updated: December 10, 2014
Last verified: December 2014

This prospective study includes patients with histologically proven cancer of the esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is performed and individual lymph node stations (Nr 1-12 according to the Japanese classification) are histopathologically examined. Furthermore we evaluate the role of the PET-CT for early metabolic response evaluation in patients receiving neoadjuvant chemotherapy.

  • Trial with surgical intervention

Condition Intervention Phase
Stomach Cancer
Cancer of Esophagogastric Junction
Procedure: FDG-PET-CT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Diagnostic Accuracy of PET-CT [ Time Frame: preoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
all patients
all patients with Adenocarcinoma
Procedure: FDG-PET-CT
Radiologic standard procedure


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Histological prove of adenocarcinoma of the stomach.

Exclusion criteria:

  • Recurrent gastric carcinoma
  • No informed consent
  • Previous malignancy (exception: thyroid, bladder in situ, Cervix in situ)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00800969

Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Zurich, Switzerland
Sponsors and Collaborators
Kuno Lehmann
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Kuno Lehmann, University of Zurich Identifier: NCT00800969     History of Changes
Other Study ID Numbers: VIS-UGI-1
Study First Received: November 28, 2008
Last Updated: December 10, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Adenocarcinoma of the stomach and esophagogastric junction

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases processed this record on October 09, 2015