First Hospital of Jilin University
Changchun, Jilin, 130012, China
Location status: Recruiting
NCT Number: NCT06929949
Gastric cancer ranks as the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. In China, its incidence and mortality rank third among all cancers. While the global incidence of gastric cancer is declining, proximal gastric cancer and adenocarcinoma of the esophagogastric junction (AEG) are on the rise. Due to the unique characteristics of AEG, there is no standardized treatment consensus, making the selection of an optimal surgical approach and reconstruction method crucial for improving patient outcomes.
For early-stage proximal gastric cancer and AEG, total gastrectomy (TG) and proximal gastrectomy (PG) are common surgical options. PG, increasingly favored for its function-preserving benefits, has been shown to be a safe and effective alternative to TG. While TG effectively removes lymph nodes and reduces reflux risk, it leads to permanent loss of gastric function and nutritional deficiencies. PG better preserves gastrointestinal function but is limited by the risk of reflux esophagitis, highlighting the need for improved reconstruction techniques.
Several reconstruction methods exist after PG, including esophagogastric anastomosis, jejunal interposition, double-tract reconstruction (DTR), double-flap technique (DFT), and tubular gastric anastomosis, each with varying efficacy in preventing reflux. Studies suggest that DTR reduces reflux and improves quality of life compared to esophagogastric anastomosis, while DFT, first introduced in 1998, has gained popularity for its advantages in maintaining nutrition and minimizing reflux. Additionally, tubular gastric anastomosis, which constructs a narrow gastric tube to facilitate tension-free anastomosis, has shown potential benefits for AEG patients.
Most existing studies on laparoscopic or robot-assisted reconstruction techniques for proximal gastric cancer are retrospective, lacking high-quality prospective evidence. Furthermore, comparative data on their anti-reflux efficacy and postoperative quality of life remains l
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Changchun, Jilin, 130012, China
Location status: Recruiting
Gastric cancer is the fifth most common malignant tumor worldwide and ranks fourth in cancer-related mortality. In China, the incidence and mortality rate of gastric cancer rank third among all malignancies. While the global incidence of gastric cancer has been steadily declining, the incidence of proximal gastric cancer has been rising. Additionally, the incidence of adenocarcinoma of the esophagogastric junction (AEG) has been increasing annually, showing an upward trend worldwide. Due to its unique anatomical location and significant tumor biological heterogeneity, there is no standardized consensus on the optimal treatment for AEG. Therefore, selecting an appropriate surgical resection and reconstruction approach remains crucial for improving the prognosis of patients with proximal gastric cancer and AEG.
For early-stage proximal gastric cancer and AEG, either total gastrectomy (TG) or proximal gastrectomy (PG) can be performed. With the advancement of function-preserving surgical concepts, PG has been increasingly recognized as a viable option. The Japanese Clinical Oncology Group (JCOG1401) trial demonstrated that laparoscopic proximal gastrectomy (LPG) is a safe and effective treatment for early-stage proximal gastric cancer compared to laparoscopic total gastrectomy (LTG). However, patients undergoing TG often experience long-term postoperative quality-of-life concerns. Although TG can effectively remove lymph nodes and reduce the risk of gastroesophageal reflux, it results in the permanent loss of gastric storage, mechanical grinding, and secretory functions, as well as reduced feasibility of postoperative endoscopic examination. TG patients may also suffer from nutritional deficiencies, including vitamin B12 deficiency, iron deficiency, weight loss, anemia, diarrhea, and dumping syndrome. In contrast, PG offers advantages in preserving gastrointestinal function and nutritional status. However, its widespread adoption is limited by the risk of reflux esophagitis. Thus, selecting an optimal reconstruct
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
The proportion of patients with reflux esophagitis diagnosed by digestive endoscopy (LA classification), barium meal (barium meal) and (GerdQ scale).
Time frame: Within 30 days after surgery
The total number of patients who underwent surgical treatment was used as the denominator, and the number of patients with any postoperative complication was used as the numerator to calculate the incidence percentage.
Time frame: Within 30 days after surgery
The total number of patients who underwent surgical treatment was used as the denominator, and the number of patients who died after surgery was used as the numerator to calculate the incidence percentage.
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Body weight will be monitored during follow-up after surgery.
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Quality of life was assessed by EORTC QLQ-STO22 questionnaires.
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Quality of life was assessed by EORTC QLQ-C30 questionnaires.
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
Hematological examination
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
CT scan was performed to assess the L3 skeletal muscle index (LSMI).
Time frame: Follow-up evaluations are performed up to 2 years postoperatively.
C13/14 examination by blowing or by endoscopic biopsy.
Time frame: Follow-up evaluations are performed up to 3 years postoperatively.
Time frame: Follow-up evaluations are performed up to 3 years postoperatively.
Contact information is provided by the study sponsor or research team.
The First Hospital of Jilin University
Other
A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
Acronym: STARS-GC10
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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