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The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Billroth II with Braun Reconstruction | Experimental |
| |
| Billroth II Reconstruction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Billroth II reconstruction | Procedure | Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reflux gastritis assessed according to RGB classification | by endoscopic evaluation | 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessed by the PGSAS-45 Scale | The preoperative and postoperative QoL of patients between the two groups. | 6 months, 12 months |
| Nutritional status | Changes in body weight (kg) or BMI from baseline |
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Inclusion criteria
To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria:
Exclusion criteria
Patients will be excluded according to the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaolun Cai, MD, PhD | Contact | +86-028-85423610 | caizhaolun@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Zhang, MD | Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University | Study Chair |
| Zhaolun Cai, MD, PhD | Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Braun Anastomosis | Procedure | This is an additional surgical connection (anastomosis) created between two parts of the small intestine, specifically between the afferent (incoming) and efferent (outgoing) limbs of the jejunum near the gastrojejunostomy (the new connection between the stomach and small intestine created during a Billroth II procedure). |
|
| 6 months, 12 months |
| Time to first passage of flatus/stool | Time taken to pass first stool or flatus | within 30 days after surgery |
| Postoperative complications (assessed according to the Clavien-Dindo) | e.g., anastomotic leakage, anastomotic bleeding assessed by laboratory test in combination with clinical features, radiological diagnostic methods, endoscopy, diagnostic laparoscopy. | within 30 days after surgery |
| Long-term complications | e.g., food residue and bile reflux (assessed according to the RGB classification). | 6 months, 12 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |