Clinical trial · Interventional
Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer
Prospective Randomized Controlled Trial on Clinical Application Value of Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery and Billroth-I Anastomosis in Laparoscopy-assisted Surgery for Distal Gastric Cancer
NCT02289183CI-TRIAL-00043201MDSGunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopy-assisted distal gastrectomy | Procedure | — | UNRESOLVED |
| Totally laparoscopic distal gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Totally laparoscopic distal gastrectomy
- description
- The totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy will be performed for the treatment of patients with distal gastric cancer assigned to this group.
- interventionNames
- Procedure: Totally laparoscopic distal gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopy-assisted distal gastrectomy
- description
- The laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis will be performed for the treatment of patients with distal gastric cancer assigned to this group.
- interventionNames
- Procedure: Laparoscopy-assisted distal gastrectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age from 18 to 75 years (including 18 and 75 years old) * Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition * Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy * Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) * American Society of Anesthesiology score (ASA) class I, II, or III * Written informed consent Exclusion Criteria: * Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging * History of other malignant disease within past five years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within past six months * History of cerebrovascular accident within past six months * History of continuous systematic administration of corticosteroids within one month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of predicted values
References
Publications (0)
Data not yet available
No reference posted for this study.