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| Name | Class |
|---|---|
| Tang-Du Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Henan Provincial People's Hospital |
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1) To explore a simple, safe, post-proximal gastrectomy reconstruction method with good absorption and digestive function in order to improve patients' postoperative quality of life; 2) To fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field in China; 3) To utilize the experience and foundation of gastrointestinal surgery in the treatment of gastric cancer and integrate the advantageous resources in China; 4) To establish a large-sample, multicenter randomized clinical study in order to promote the establishment and improvement of relevant norms of gastrointestinal reconstruction
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths each year. Although the incidence of gastric cancer has decreased worldwide compared to the past, the incidence of esophagogastric junction cancer and upper 1/3 gastric cancer is gradually increasing. Currently, the main treatment for esophagogastric junction cancer and upper gastric cancer is surgery. However, there is no clinical consensus on the choice of surgical approach for these patients. Compared with total gastrectomy, proximal gastrectomy can preserve the physiological function of the stomach and has great advantages in nutrient absorption, thus it has been widely accepted in Asian countries.
However, the risk of developing reflux esophagitis after proximal gastrectomy is high, which seriously affects patients' postoperative quality of life. In order to reduce the occurrence of postoperative complications, clinicians continue to improve the methods of GI reconstruction. Currently, the common methods of GI reconstruction after proximal gastrectomy include esophagogastrostomy (EG), jejunal intubation (JI), jejunal pouch intubation (JPI), and dual-tract reconstruction (DTR). However, the choice of the optimal reconstruction method after proximal gastrectomy remains controversial, and there is no standard approach to GI reconstruction. In 2016, Kuroda et al. reported a new surgical approach with a double-flap technique after proximal gastrectomy and showed satisfactory short-term outcomes compared with conventional esophagogastric anastomosis. At the 1-year postoperative follow-up, no reflux esophagitis was detected in all patients. At the same time, the rate of anastomotic stenosis was noteworthy.
This study will be the first attempt at a left-open single-flap technique, which was modified from the double-flap technique. The short-term outcome was satisfactory in all patients. This study will establish a large sample, multicenter randomized clinical study. By exploring a simple, safe, good absorption and digestive function method of post-proximal gastrectomy reconstruction to improve patients' postoperative quality of life and fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field. This will promote the establishment and improvement of the specifications related to gastrointestinal reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the trial group (left-opening single-flap group) | Experimental | left-opening single-flap group |
|
| the control group (double-flap group) | Active Comparator | double-flap group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left-opening single-flap technique | Procedure | left-opening single-flap technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reflux esophagitis | Incidence of reflux esophagitis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall postoperative complication rate | Overall postoperative complication rate | 30 days |
| Incidence of anastomotic fistula | Incidence of anastomotic fistula |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Li, MD | Contact | +8613474299901 | xjyylixiaohua@163.com | |
| Gang Ji, MD | Contact | +8613572152581 | xijingweichang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nan Wang, MD | Tang-Du Hospital | Study Chair |
| Chao Zhang, MD | Henan Provincial People's Hospital | Study Chair |
| Lei Wang, MD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36465382 | Derived | Yang QC, Wang WD, Mo ZC, Yue C, Zhou HK, Gao RQ, Yu J, Dong DH, Liu JQ, Wei JP, Yang XS, Ji G, Li XH. Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial. Front Oncol. 2022 Nov 17;12:973810. doi: 10.3389/fonc.2022.973810. eCollection 2022. |
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| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
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| double-flap group technique | Procedure | double-flap group technique |
|
| 30 days |
| Operation time | Operation time | intraoperative |
| Bleeding loss volume | Bleeding loss volume | intraoperative |
| incidence of anastomotic stricture | incidence of anastomotic stricture | 30 days |
| Incidence of reflux esophagitis | Incidence of reflux esophagitis | 6 days |
| General Hospital of Ningxia Medical University |
| Study Chair |
| Renwei Chang, MD | The First Affiliated Hospital of Shanxi Medical University | Study Chair |
| Junjun She, MD | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |