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

NCT06475170 | Recruiting

• 1 other identifier: NorthernJiangsu1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; Reflux Esophagitis

Outcome Measures

Primary Outcomes (1)

• incidence of reflux esophagitis

  The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.

  12 months after surgery

Secondary Outcomes (3)

• incidence of anastomotic leakage

  30 days after surgery

• incidence of anastomotic stenosis

  12 months after surgery

• operative time

  1 day after surgery

Study Arms (2)

λ+α double-tract anastomosis

EXPERIMENTAL

Procedure: proximal gastrectomy combined with 'λ+α' double-tract anastomosis

double-tract anastomosis

ACTIVE COMPARATOR

Procedure: proximal gastrectomy combined with 'λ+α' double-tract anastomosis

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；

double-tract anastomosis; λ+α double-tract anastomosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years old, male or female; Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15); No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT; ASA grade 1-3; Patients without contraindications to surgery; Patients and their families voluntarily signed the informed consent form and participated in the study;

You may not qualify if:

• Patients diagnosed with primary tumors or distant metastasis; Patients whose tumor is located in the greater curvature side of the stomach; Patients with coagulation dysfunction that could not be corrected; Patients who were diagnosed with viral hepatitis and cirrhosis; Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin; Patients with organ failure such as heart, lung, liver, brain, and kidney failure; Patients with ascites or cachexia preoperatively in poor general conditions; Patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
• Patients refusing to sign the informed consent of the study;

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People'S Hospital

Yangzhou, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophagitis; Esophageal Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Central Study Contacts

Daorong Wang

CONTACT

18051062590; wdaorong666@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Northern Jiangsu People's Hospital

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CN (1)