Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorP. Herzen Moscow Oncology Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert I and II) cT1-3N0-2M0 undergoing proximal gastrectomy with curative intent - via open, laparoscopic or robotic approach between 01th January 2025 and 31th December 2026

Disqualifiers

Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on a previous staging laparoscopy, or those with known synchronous other cancers.

Esophagogastric Junction Siewert I malignancy

Patients submitted to Emergency surgery or surgery without curative intent

Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Proximal Gastrectomy

    Procedure/Surgery

    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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Patients with morbidity and mortality1 intervention
Group B: Patients without morbidity and mortality1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
within 90 days after operation
2

Overall survival

Overall survival within 1 year after operation

Time frame
1 year after operation
3

Frequency of local recurrence

Frequency of local recurrence within 1 year after operation

Time frame
1 year after operation
4

Frequency of tumor progression

Frequency of tumor progression within 1 year after operation

Time frame
1 year after operation

Secondary outcomes

1

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

Time frame
6 and 12 months after surgery
2

Incidence of development of esophageal anastomotic stricture

Incidence of development of esophageal anastomotic stricture in the postoperative period.

Time frame
6 and 12 months after surgery
3

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

Time frame
6 and 12 months after surgery
4

Pressure of the esophageal anastomosis

Pressure of the esophageal anastomosis in the postoperative period according to esophageal manometry

Time frame
6 and 12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

P. Herzen Moscow Oncology Research Institute

Lead sponsor

A.Loginov Moscow Clinical Scientific Center

Collaborator