Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer

NCT05585073 | Completed

• 1 other identifier: SD-GC
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.

Conditions

Surgery-Complications

Outcome Measures

Primary Outcomes (1)

• surgery complicated

  Incidence of operative complications between qualified group and unqualified group

  30 days after operation

Study Arms (2)

qualified of D2 Lymph node dissection group

Other: Whether lymph node dissection is qualified or not

not-qualified D2 Lymph node dissection group

Other: Whether lymph node dissection is qualified or not

Interventions

Whether lymph node dissection is qualified or not OTHER

Klass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND

not-qualified D2 Lymph node dissection group; qualified of D2 Lymph node dissection group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The CLASS-01 trial is a prospective multicenter randomized controlled study (ClinicalTrials.gov.number:NCT01609309) to compare the oncological efficacy of laparoscopy and laparotomy in the treatment of locally advanced distal gastric cancer. In this study, 119 patients who underwent laparoscopic surgery at our center who participated in CLASS-01 were selected. All the patients were operated with 2D laparoscopic system.The 2D/3D trial is a prospective clinical trial (ClinicalTrials.gov.number:NCT02327481) that compares the curative effect of 2D and 3D laparoscopic radical gastrectomy in our center. Seventy cases of 2D laparoscopic distal gastrectomy (LDG) were selected

You may qualify if:

• all patients undergoing laparoscopic surgery
• Laparoscopic system is 2D and has complete D2 lymph node dissection.

You may not qualify if:

• patients undergoing laparotomy
• incomplete video or clinicopathological information

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Gastric Surgery

Fuzhou, Fujian, China

Location

Related Publications (1)

• Lu J, Huang JB, Wu D, Xie JW, Wang JB, Lin JX, Zheng CH, Huang CM, Li P. Factors affecting the quality of laparoscopic D2 lymph node dissection for gastric cancer: a cohort study from two randomized controlled trials. Int J Surg. 2023 May 1;109(5):1249-1256. doi: 10.1097/JS9.0000000000000290.

  PMID: 37026819 DERIVED

MeSH Terms

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 18, 2022
• Study Start: January 1, 2022
• Primary Completion: May 10, 2022
• Study Completion: June 20, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)