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Totally Laparoscopic Total Gastrectomy (overlap reconstruction) versus Laparoscopic-Assisted Total Gastrectomy for the safety and efficacy of locally advanced Siewert III Esophagogastric Junction Cancer and upper and middle part of gastric cancer: The Study Protocol for a Single-Center Randomized Controlled Trial

Totally Laparoscopic Total Gastrectomy (overlap reconstruction) versus Laparoscopic-Assisted Total Gastrectomy for the safety and efficacy of locally advanced Siewert III Esophagogastric Junction Cancer and upper and middle part of gastric cancer: The Study Protocol for a Single-Center Randomized Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025667
Enrollment
Unknown
Registered
2019-09-04
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

locally advanced Siewert III Esophagogastric Junction Cancer and upper and middle part of gastric cancer

Interventions

TLTG overlap:TLTG overlap
LATG:LATG

Sponsors

Xijing Hospital, the Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) age between 18–65 years; 2) Siewert type III adenocarcinoma of esophagogastric junction and upper and middle part of gastric cancer; 3) not received neoadjuvant chemotherapy; 4) feasible to perform D2 (lymph node dissection according to the Japanese gastric cancer guidelines 2010 third edition recommended) radical total gastrectomy (R0 resection), 5) absence of distant metastases and surrounding adjacent organ invasion on preoperative contrast enhanced computed tomography (CT) chest and abdomen; 6) preoperative staging cT2-4aN0-3M0 (according to AJCC-7th TNM tumor staging); 7) voluntary participation in the study and provide informed consent; 8) preoperative ECOG score of 0 to 2; 9) preoperative white blood cells (WBC) >= 3 x10^9 / L, absolute neutrophil count (NEU) >= 1.5 x10^9/L, platelet (PLT) >= 100 x10^9/L; 10) preoperative ASA score I-III.

Exclusion criteria

Exclusion criteria: 1) contraindications for laparoscopic surgery; 2) uncontrolled severe medical diseases, including unstable angina or myocardial infarction within 6 months, congestive heart failure greater than NYHA 2, arrhythmia requiring antiarrhythmic drugs, thrombosis or embolic events within 6 months, severe central nervous system, blood system disease or heart, lung, liver, kidney dysfunction and immunodeficiency, liver cirrhosis, portal hypertension, splenomegaly; 3) trauma, fracture, or serious surgery within 6 weeks before the start of the study; 4) autologous bone marrow transplantation or stem cell rescue treatment within 4 months before the start of the study; 5) history of allogeneic organ transplantation; 6) pregnant or lactating women; 7) serious mental illness; 8) history of previous esophageal or gastric surgery; 9) history of other malignant tumors within 5 years; 10) emergency surgery; 11) participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Overall complications occurred within 30 days after surgery;

Secondary

MeasureTime frame
3-year disease free survival;3-year overall survival;

Countries

China

Contacts

Public ContactGang Ji

Xijing Hospital, the Fourth Military Medical University

jigangfmmu@163.com+86 29-84771525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026