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| Name | Class |
|---|---|
| A.Loginov Moscow Clinical Scientific Center | UNKNOWN |
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Proximal gastric and esophagogastric junction cancers comprise up to 40% of gastric malignancies. For localized disease, proximal gastrectomy is the main radical procedure, but reconstruction of GI tract often leads to significant functional issues.
Rising use of proximal resections and broader indications have increased attention to postoperative quality of life (QoL). Common reconstructions include direct esophagogastrostomy (various types), double-tract reconstruction, jejunal interposition, and newer anti-reflux anastomoses (e.g., double-flap, overlap, tunnel techniques).
Each method has unique pros and cons regarding reflux esophagitis, food passage, dumping syndrome, nutritional changes, and long-term QoL.
No consensus exists on the optimal technique, leading to variable practices and outcomes. Most research focuses on oncologic radicality and survival, while functional results and QoL remain understudied.
Systematic evaluation of functional outcomes across reconstruction types after proximal subtotal gastrectomy is needed in Russian Federation to improve QoL, advance research, and standardize treatment of proximal gastric and EGJ cancers.
Proximal gastric and esophagogastric junction cancer account for up to 40% of all gastric malignancies. For localized disease, proximal gastrectomy remains the primary radical surgical procedure. However, roconstruction of gastrointestinal continuity after this procedure is associated with significant functional disturbances.
The increasing frequency of proximal resections and expanding indications have heightened focus on postoperative quality of life (QoL). Currently used reconstruction techniques include direct esophagogastrostomy (in various modifications), double-tract reconstruction, jejunal interposition, and emerging anti-reflux esophagogastric anastomoses (e.g., double-flap technique, single-overlap, tunnel reconstruction, etc).
Each method carries distinct advantages and disadvantages concerning reflux esophagitis, food passage, dumping syndrome, nutritional status alterations, and long-term QoL.
Despite this variety, no universal consensus exists regarding the optimal reconstruction technique, resulting in heterogeneous surgical practices and variable functional outcomes. Most studies prioritize oncologic radicality and overall survival, whereas functional results and QoL remain under-investigated.
To enhance patient QoL, advance research, and standardize treatment of proximal gastric and esophagogastric junction cancers in the Russian Federation, there is a clear need for systematic evaluation of functional outcomes across different reconstruction types following proximal subtotal gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with morbidity and mortality | Patients who suffered from any type of morbidity after surgery |
| |
| Patients without morbidity and mortality | Patients who did not suffered from any type of morbidity after surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal Gastrectomy | Procedure | Resection of the upper third to one-half of the stomach and the distal portion of the esophagus with different types of digestive system reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment | the types of complication is classified into as follows: esophageal anastomotic leak requiring surgical treatment, esophageal anastomotic leak not requiring surgical treatment, gastric stump necrosis, postoperative bleeding requiring surgical treatment, postoperative bleeding not requiring surgical treatment, postoperative ileum, postoperative pancreatic fistula type B, postoperative pancreatic fistula type C, duodenal stump leak / duodenal stump insufficiency, impaired evacuation from the gastric stump (more than 10 days after surgery), postoperative intestinal perforation or necrosis, persistent air leak through the pleural drain, wound dehiscence (evisceration, hernia), incarcerated diaphragmatic hernia, chylothorax or other types of lymph leakage, infectious complications of the postoperative wound, other complications requiring repeat intervention or another invasive procedure, other. | within 90 days after operation |
| Overall survival | Overall survival within 1 year after operation | 1 year after operation |
| Frequency of local recurrence | Frequency of local recurrence within 1 year after operation | 1 year after operation |
| Frequency of tumor progression | Frequency of tumor progression within 1 year after operation | 1 year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of development and the severity of reflux esophagitis | Incidence of development and the severity (degree of expression) of reflux esophagitis according to the Los Angeles classification in the postoperative period | 6 and 12 months after surgery |
| Incidence of development of esophageal anastomotic stricture |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert II and III) cT1-3N0-2M0undergoing elective proximal gastrectomy curative intent - via open, laparoscopic or robotic approach
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrey Ryabov, MD, PhD | Contact | +7 (495) 150-11-22 | ryabovdoc@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Andrey Ryabov, MD, PhD | P.Herzen Moscow Oncological Research Institute | Study Director |
| Vladimir Khomyakov, MD, PhD | P.Herzen Moscow Oncological Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P.Herzen Moscow Oncological Research Institute | Recruiting | Moscow | Russia |
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Incidence of development of esophageal anastomotic stricture in the postoperative period. |
| 6 and 12 months after surgery |
| Incidence and severity of dumping syndrome | Incidence and severity of dumping syndrome, along with quality of life assessment in the postoperative period according to the KOQUSS-40 questionnaire at 6 and 12 months postoperatively | 6 and 12 months after surgery |
| Pressure of the esophageal anastomosis | Pressure of the esophageal anastomosis in the postoperative period according to esophageal manometry | 6 and 12 months after surgery |
| The level of body weight reduction | The level of body weight reduction in the postoperative period | 6 and 12 months after surgery |
| The level of hemoglobin | The level of hemoglobin in 6 and 12 months after surgery | 6 and 12 months after surgery |
| Food passage rate through the esophagus and the stump of the stomach | The rate of passage of food through the esophagus and the stump of the stomach, as well as evacuation from the stump of the stomach into the small intestine based on scintigraphy of the stomach and esophagus after 12 months after surgery | 6 and 12 months after surgery |
| Nuriddin Abdulkhakimov, PhD |
| P.Herzen Moscow Oncological Research Institute |
| Principal Investigator |
| Pavel Smirnov | P.Herzen Moscow Oncological Research Institute | Principal Investigator |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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