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Comparison of the efficacy and prognosis of different digestive tract reconstruction methods in laparoscopic radical gastrectomy for distal gastric cancer

Comparison of the efficacy and prognosis of different digestive tract reconstruction methods in laparoscopic radical gastrectomy for distal gastric cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037056
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

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:Roux-en-Y
Group 2:Billroth II+Braun
Group 3:uncut Roux-en-Y

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with age >= 18 years and <= 75 years old; 2. Patients with resectable distal gastric malignant tumor confirmed by PET-CT, abdominal enhanced CT, gastroscopy and pathology, or advanced distal gastric malignant tumor with surgical indications after MDT neoadjuvant / transformation therapy; 3. All patients underwent total laparoscopic distal gastrectomy (D2 lymph node dissection); 4. Patients who voluntarily participate in this study should sign the informed consent form. If the subjects can not read or sign, the informed consent form should be signed by the legal representative under the condition of informed consent of the subjects. For the subjects who are unable to express their consent, the above introduction and explanation should be provided to their legal representatives, and the legal representatives should sign the informed consent form; 5. Patients of childbearing age and their spouses are willing to take contraceptive measures.

Exclusion criteria

Exclusion criteria: 1. Patients with upper gastrointestinal bleeding and tumor perforation need emergency surgical intervention; 2. Patients with previous history of upper abdominal surgery or extensive abdominal adhesions found by laparoscopic exploration; 3. Patients with ASA grade IV; 4. Patients with severe adhesion to surrounding tissues were included in the advanced gastric cancer group, and the MDT; team assessed that they could try open surgery, but could not perform laparoscopic surgery; 5. Patients with severe hematological and immune system diseases or malignant tumors of other tissues and organs; 6. Patients with other serious diseases, including but not limited to: (1) Uncontrollable congestive heart failure (NYHA grade III or IV), unstable angina pectoris, poorly controlled arrhythmia, uncontrolled moderate hypertension (SBP > 160mmhg or DBP > 100mmhg). (2) Active infection. (3) Uncontrolled diabetes. (4) HIV infection. (5) Patients with interstitial pneumonia or low oxygen saturation. (6) Active autoimmune diseases requiring long-term steroid use. (7) Patients who have received allografts. (8) Mental illness affecting informed consent and / or protocol compliance. (9) Severe cirrhosis, bleeding and coagulation dysfunction (INR > 1.3) and peripheral platelet count were significantly reduced < 50x10^9 / L; 7. Patients with serious diseases considered unsuitable for the study by other researchers.

Design outcomes

Primary

MeasureTime frame
perioperative complications;Grading of bile reflux under endoscope;Quality of life;Readmitment state within 30 days after surgery;

Secondary

MeasureTime frame
Two years disease-free survival;Two years overall survival;

Countries

China

Contacts

Public ContactPing Dong

Xinhua Hospital afflicted to Shanghai JiaoTong University School of Medicine

dongping_1050@163.com+86 13918005687

Outcome results

None listed

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