Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy

Last updated: December 5, 2020
Sponsor: Zhejiang Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Heartburn

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT04657848
2020361093
  • Ages 18-70
  • All Genders

Study Summary

In the past years, the adenocarcinoma of the esophagogastric junction (AEG) has been increasing obviously in China. It may be caused by the reason of increased body weight, alcohol consumption, gastroesophageal reflux disease and premalignant. In western countries, the 5-year rate of advanced AEG was less than 30%, it was the same in China. There was significant difference in epidemiology, pathogenic mechanism, biological characteristics and prognosis between AEG and antrum tumors, so AEG was regarded as a kind of independent disease. Up till now, the scope of lymph node dissected, the selection of operation approach, the resection range and the digestive tract reconstruction for the treatment of AEG were in dispute, especially in the reconstruction of digestive tract after operation. The purpose of this study is to investigate the efficacy and safety of the proximal gastrectomy combined with Giraffe anastomosis for early adenocarcinoma of esophagogastric junction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Preoperative endoscopy and biopsy confirmed adenocarcinoma of esophagogastricjunction, and predictively feasible of transabdominal proximal gastrectomy.
  2. Early gastric cancer, of preoperative staging AJCC 8th Edition cT1N0M0 and notsuitable for endoscopic resection;
  3. Completion of abdominal CT scan and ultrasound endoscopy
  4. Age：18 to 70 years ;
  5. Karnofsky score ≥ 70
  6. With good compliance and informed consent required.

Exclusion

Exclusion Criteria:

  1. Pregnancy, breast-feeding women.
  2. The existence of the peripheral nervous system disorders or significant neurologicaldisorders and a history of central nervous system disorders.
  3. Severity mental diseases;
  4. Patients with other severe complications cannot tolerate surgery: such as severe heartand lung diseases, heart function below clinical stage 2, uncontrollable hypertension,pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD Bgrade, and severe malnutrition, etc.
  5. With other malignancies which were not cured.
  6. Patients have already joined other clinical trials
  7. After signature the Clinical trial agreement, patients and their agent will quit thetrial.

Study Design

Total Participants: 100
Study Start date:
June 01, 2020
Estimated Completion Date:
June 01, 2023

Study Description

In the past years, the adenocarcinoma of the esophagogastric junction (AEG) has been increasing obviously in China. It may be caused by the reason of increased body weight, alcohol consumption, gastroesophageal reflux disease and premalignant. In western countries, the 5-year rate of advanced AEG was less than 30%, it was the same in China. There was significant difference in epidemiology, pathogenic mechanism, biological characteristics and prognosis between AEG and antrum tumors, so AEG was regarded as a kind of independent disease. Up till now, the scope of lymph node dissected, the selection of operation approach, the resection range and the digestive tract reconstruction for the treatment of AEG were in dispute, especially in the reconstruction of digestive tract after operation.

The digestive tract reconstruction methods for AEG II were determined by the surgical approach. The controversy exists regarding whether reconstruction method with low esophageal reflux should be used to treat AEG patients. The gastric tube reconstruction, the antrum-preserving double-tract reconstruction and the Roux-en-Y reconstruction were the common methods. Some studies showed that the 24-h pH profile in the patients with gastric tube reconstruction was similar to the healthy person, but it may be related to the increasing incidence of gastroesophageal reflux disease in the healthy person and the anti-reflux medication used in the patients. Although the antrum-preserving double-tract reconstruction have a good function of anti-reflux, the complicated operation and too many anastomotic stomas increased the rate of postoperative happened. The common physiological mechanism of anti-reflux was caused by the lower esophageal sphincter, esophagogastric junction, His angle and so on. Therefore, in our center, we use a new reconstruction which combine the advantages of gastric tube reconstruction with rebuilding the His angle and fundus of gastric. We call it Gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Giraffe anastomosis).

Connect with a study center

  • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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