Preliminary Efficacy Analysis of 'λ+α' Double-Tract Reconstruction After Laparoscopic Proximal Gastrectomy

Sponsor
Northern Jiangsu People's Hospital
Study ID
NCT06475170
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • proximal gastrectomy combined with 'λ+α' double-tract anastomosis — PROCEDURE
    1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines 2. Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. 3. The jejunum is dissected 30 cm from the flexor ligament and the distal jejunum is lifted in an anterior colonic direction to the esophageal dissection. 4. Esophagojejunal anastomosis at 16 cm from the distal jejunal stump； 5. Residual gastrojejunostomy at 8 cm from the distal jejunal stump；

Study Details

The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, based on the stomach's anatomical features and the intercalated jejunum's anti-reflux mechanism, we propose a true dual-channel anastomosis for GI reconstruction, i.e., the "λ+α dual-channel anastomosis". This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "λ+α double-channel anastomosis" in the treatment of early gastric cancer.

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: λ+α double-tract anastomosis
  • Active Comparator: double-tract anastomosis

Primary Outcome Measure

incidence of reflux esophagitis [ Time Frame: 12 months after surgery ]

Central Contacts

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