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A prospective randomized controlled trial of comparing the peri-operative safety and short-term quality of life between two intracorporeal gastroduodenostomy

A prospective randomized controlled trial of comparing the peri-operative safety and short-term quality of life between two intracorporeal gastroduodenostomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036747
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Gastric Cancer

Interventions

DA group:Totally laparoscopic distal gastrectomy with Delta-shaped gastroduodenostomy
Delta SPLT group:Totally laparoscopic distal gastrectomy with Self-pulling and latter transected delta-shaped gastroduodenostomy

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 and <= 85 years; 2) Histologically proven gastric adenocarcinoma or high-grade intraepithelial neoplasia (cTis-3NxM0, by preoperative gastrofiberscopy); 3) The longest diameter of the tumor is no larger than 3cm and without pyloric invasion; 4) Eastern Cooperative Oncology Group (ECOG) performence status:0 or 1; 5) ASA physical status class I-III; 6) Patients are voluntarily enrolled into the study, sign the informed consent form and have good compliance.

Exclusion criteria

Exclusion criteria: 1) Pregnant or breast-feeding women 2) History of severe psychosis; 3) Previous epigastric intra-abdominal surgery (exclude laparoscopic cholecystectomy); 4) Bulky lymph nodes (>3cm) detected by preoperative examination; 5) History of other malignant tumor in the last 5 years; 6) History of neo-adjuvant chemotherapy or radiotherapy; 7) No indication for D2 lymphadenectomy; 8) History of unstable angina of myocardial infarction in the past 6 months; 9) History of cerebral infarction or cerebral hemorrhage in the past 6 months; 10) History of continuous generalized adrenal cortex hormone treatment in the past 1 month; 11) Other simultaneous surgery; 12) Emergent surgery.

Design outcomes

Primary

MeasureTime frame
Perioperative safety;

Secondary

MeasureTime frame
Short-term quality of life;Long-term quality of life;

Countries

China

Contacts

Public ContactJun Hong
cosmoshong@hotmail.com+86 13917478196

Outcome results

None listed

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