The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03478449
• Other study ID #: DJY001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2020
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 276
• Est. completion date: December 30, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1) Physical conditions compliance with the requirements for curative gastrectomy

• 2) Consent to undergo the D2 lymphadenectomy

• 3) Comply with the protocol during the whole study period

• 4) No neoadjuvant therapy administration

• 5) Sign informed consent and permission of withdraw in the whole study period

• 6) Consent to provide the tissue specimens after surgery for this study

• 7) Pathological examination confirmation the adenocarcinoma of stomach before surgery

• 8) Estimation the overall survival after surgery no less than 6 months

• 9) No anesthesia or operation contraindication disease

• 10) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations

• 11) Negative cytological detection in operation

• 12) No seriously concomitance's diseases

• 13) Karnofsky Performance Scores (KPS) more than 60

Exclusion Criteria:

• 1) Women during pregnant stage and breast-feed stage

• 2) Women of childbearing age without any contraceptive measures

• 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months

• 4) Immunosuppressive therapists for organ transplantation

• 5) Seriously uncontrolled recurrent infection

• 6) other malignant tumors

• 7) No abilities of self-knowledge or mental disorders

• 8) Participating in other clinical trials

• 9) Siewert I and II esophagogastric junction tumors

• 10) Serious internal diseases obstruction surgery

Related Conditions & MeSH terms

• Exanimation
• Gastric Cancer
• Lymph Node Metastases
• Stomach Neoplasms

Intervention

Procedure:
• lymph node sorting for pathological examination
In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.

Locations

Country	Name	City	State
China	Cancer Hospital of Tianjin Medical University	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration of pN stage in gastric cancer patients	According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.	60 months