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To evaluate the safety and clinical value of lymph nodes dissection of hepatoduodenal ligament in advanced distal gastric cancer: a randomized controlled trial.

To evaluate the safety and clinical value of lymph nodes dissection of hepatoduodenal ligament in advanced distal gastric cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032440
Enrollment
Unknown
Registered
2020-04-28
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

Group 1:D2+ lymph node dissection of hepatoduodenal ligament
Group 2:D2 lymphadenectomy

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Primary gastric adenocarcinoma confirmed by histopathology; (2) Aged from 20 to 75 years old; (3) At least 15 lymph nodes were biopsied after operation; (4) Clinically resectable evaluated by MDT before surgery and distal radical gastrectomy proposed. Not emergency surgery. (5) Patients with local progression (cT3-4NxM0 or cTxN1-3M0) evaluated by preoperative CT. cT3-4 means the tumor invades the serosal layer.

Exclusion criteria

Exclusion criteria: (1) Previous or concurrent history of other tumors; (2) Patients with residual gastric cancer or recurrent residual gastric cancer; (3) Proposed neoadjuvant chemotherapy after multidisciplinary disscussion; (4) With distant metastasis (e.g., liver, lung, extraregional lymph node metastasis, peritoneal implantation) and positive cytology of peritoneal lavage fluid; (5) With hepatoduodenal lymphadenopathy evaluated by preoperative imaging; (6) Poor basic condition, unable to tolerate surgery. Preoperative ASA scores >= 4; (7) Pregnant or lactating women; (8) Patients who refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Overall 5-year survival;

Secondary

MeasureTime frame
5-year and 10-year recurrence-free survival;Overall 10-year survival;Surgery complications;Surgery-associated mortality;The total number of lymph nodes obtained;The total number of positive lymph nodes;TNM staging;

Countries

China

Contacts

Public ContactShirong Cai

The First Affiliated Hospital, Sun Yat-Sen University

caisrteam@163.com+86 13005199688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026