Clinical trial · Interventional
Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy
Remnant Stomach-jejunum Double Tract Anastomosis vs. Gastric Tube Anastomosis to Proximal Gastrectomy of Early Gastric Cancer- a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough paticipants enroll in this study.
Summary
Brief summary (as posted)
Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. When compared with the advanced upper third gastric cancer, proximal gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric cancer located in the upper third of the stomach. However, due to abandon the anti-reflux barrier of the digestive system caused by the dissection of the cardia and the lower esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as well as the reflux esophagitis caused by the traditional esophagostomy permanently influence the postoperative quality of life for those patients. Nowadays, relationship between the digestive track reconstruction for proximal gastrectomy and the postoperative quality of life is still with controversies. Previous study reported the gastric tube anastomosis can minimize the reflux related symptoms when compared with traditional esophagogastrostomy. There still exited some patients need long-term anti-acid drug to control the reflux symptoms although underwent the gastric tube anastomosis. The double-track anastomosis for proximal gastrectomy may successfully control the reflux symptoms and there existed study found it is as safe as the esophagostomy. But there has no randomized control study to compare the postoperative quality of life between the gastric tube anastomosis and double-track anastomosis for proximal gastrectomy. By the reasons above, a randomized controlled trial is conducted with the intention to compare the intraoperative and postoperative mortality and morbidity and the postoperative quality of life between the esophagogastrostomy and the double-track anastomosis in the proximal gastrectomy for gastric cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complications | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Reflux Esophagitis | — | UNRESOLVED | — |
| Remnant Gastritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Double-track anastomosis | Procedure | — | UNRESOLVED |
| Gastric tube anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group B (double-track anastomosis)
- description
- Patients in the Group B will received the double-track anastomosis with proximal gastrectomy.
- interventionNames
- Procedure: Double-track anastomosis
- type
- OTHER
- label
- Group A (Gastric tube anastomosis)
- description
- Patients in the Group A (Gastric tube anastomosis) will take the gastric tube anastomosis with proximal gastrectomy.
- interventionNames
- Procedure: Gastric tube anastomosis
Primary outcomes (1)
- measure
- postoperative mortality and morbidity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma, and predictively feasible of proximal gastrectomy ; 2. Predictively resectable diseases, early gastric cancer, of preoperative staging JGCA 14th Edition cT1N0M0-T2N0M0; 3. Age:≤75 years, or ≥18 years; 4. Without serious disease and malignance disease; 5. Patients without previous history of upper abdominal surgery; 6. WHO performance score ≤2, ASA score ≤3; 7. No limit to sexual and race; 8. informed consent required. Exclusion Criteria: 1. With the history of the malignance disease; 2. Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc. 3. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation; 4. Severity mental diseases; 5. After signature the Clinical trial agreement, patients and their agent will quit the trial; 6. primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery 7. After signature the Clinical trial agreement, patients and their agent will quit the trial.
References
Publications (0)
Data not yet available