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Life Quality and Efficacy Between Double-flap Technique (Kamikawa) and Side-Overlap Anastomosis (SOFY) after Proximal Gastrectomy: Study Protocol for a Prospective, Randomized Controlled Trial

Life Quality and Efficacy Between Double-flap Technique (Kamikawa) and Side-Overlap Anastomosis (SOFY) after Proximal Gastrectomy: Study Protocol for a Prospective, Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055560
Enrollment
Unknown
Registered
2022-01-12
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

gastric cancer

Interventions

Experimental group:Kamikawa anastomsis
Control group:SOFY anastomsis

Sponsors

Beijing Friendship Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Siewert type ? / ? esophagogastric junction carcinoma, cT1-2N0M0, tumor length <= 4 cm, longer abdominal esophagus; 2. Radical gastrectomy of proximal gastric cancer is required, and more than 1/2 of the distal remnant stomach can be preserved after resection; 3. Aged 18 to 75 years, regardless of gender, physical strength score ECOG <= 2 points, ASA <= 2 points, can tolerate surgical treatment, liver, kidney, bone marrow function normal; 4. Be able to comply with the protocol during the study and sign the informed consent; 5. Patients are willing to accept follow-up and cooperate with professional staff to make relevant records; 6. No history of gastrointestinal surgery, malignant tumor, chemotherapy or radiotherapy.

Exclusion criteria

Exclusion criteria: 1. Radical total gastrectomy is required; 2. SOFY or Kamikawa anastomosis is not suitable for esophagogastric junction carcinoma with tumor invasion of dentate line or large tumor range; 3. Patients with severe heart and lung disease who cannot tolerate surgery; 4. Patients who are unwilling to bear the risks of surgery and fail to sign the informed consent for surgery; 5. Uncontrollable medical diseases (including unstable angina pectoris, myocardial infarction and cerebrovascular accident within 6 months); 6. Unable to receive general anesthesia or surgery due to other organ conditions; 7. Have a history of uncontrolled epilepsy, central nervous system disease or mental disorder; 8. Organ transplantation requiring immunosuppressive therapy; 9. Serious and uncontrolled recurrent infection, or other serious and uncontrolled concomitant diseases; 10. Continuous systemic steroid hormone therapy; 11. Pregnant or lactating women of childbearing age; 12. Participate in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The incidence of reflux after operation;

Secondary

MeasureTime frame
PGSAS-45 scores;

Countries

China

Contacts

Public ContactYin Jie

Beijing Friendship Hospital,Capital Medical University

yj232325@sina.com+86 10 63138768

Outcome results

None listed

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