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Feasibility and safety of laparoscopic proximal gastrectomy with double flap anastomosis for early gastric cancer: a phase II single-center, single-arm study

Feasibility and safety of laparoscopic proximal gastrectomy with double flap anastomosis for early gastric cancer: a phase II single-center, single-arm study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037823
Enrollment
Unknown
Registered
2020-09-02
Start date
2020-09-07
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

Gastric Cancer

Interventions

group interventon:surgery

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20 - 80 years; 2. Informed consent; 3. The proximal 1/3 primary gastric lesion was pathologically diagnosed as gastric adenocarcinoma by endoscopic biopsy; 4. Preoperative staging was T1N0-1M0 or T2N0M0 (according to ajCC-8THTNM tumor staging); 5. Preoperative ASA score was I-III; 6. Patients with cardiopulmonary function can tolerate laparoscopic surgery.

Exclusion criteria

Exclusion criteria: 1. The patient has a history of upper abdominal surgery and is not suitable for laparoscopic surgery. 2. The intraoperative anastomosis of residual esophagus and stomach is too large, so the reconstruction method needs to be changed. 3. The tumor invaded the esophagus by more than 3cm of dentate line; 4. Has a serious mental illness; 5. Pregnant women; 6. A history of continuous systemic corticosteroid or immunosuppressive drug therapy within 1 month.

Design outcomes

Secondary

MeasureTime frame
Nutrition indicators;Operative time;number of harvested lymph nodes;R0 resection rate;intraoperative blood loss;unplanned hospitalization rate within 30 days after surgery;mobidity;motality within 30-day after operation;

Primary

MeasureTime frame
Incidences of reflux esophagitis and anastomotic stenosis 12 months after operation;

Countries

China

Contacts

Public ContactHan Fanghai

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

fh_han@163.com+86 13580317677

Outcome results

None listed

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