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

Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy in Early Adenocarcinoma of Esophagogastric Junction : A Prospective Open-label Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Reflux Esophagitis
• Intervention / Treatment: Procedure: proximal gastrectomy combined with Cheng's Giraffe reconstruction

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangdong Cheng, MD; Phone Number: +86-05714758155013; Email: zyq201003@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
      • Contact: Xiangdong Cheng, MD; Phone Number: +86-05714758155013; Email: zyq201003@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Preoperative endoscopy and biopsy confirmed adenocarcinoma of esophagogastric junction, and predictively feasible of transabdominal proximal gastrectomy.
2. Early gastric cancer, of preoperative staging AJCC 8th Edition cT1N0M0 and not suitable 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 Criteria:

1. Pregnancy, breast-feeding women.
2. The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
3. Severity mental diseases;
4. Patients with other severe complications cannot tolerate surgery: such as severe heart and 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 B grade, 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 the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: proximal gastrectomy combined with Cheng's Giraffe reconstruction; proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)	Procedure: proximal gastrectomy combined with Cheng's Giraffe reconstruction; proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of reflux esophagitis after operation	The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification and the reflux disease questionnaire (RDQ) scores were used to evaluate postoperative gastroesophageal reflux.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative quality of life: European Organization for Research and Treatment of Cancer (EORTC)	Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome.	12 months
Postoperative recovery	postoperative complication rate according to the Clavian-Dindo classification, postoperative death rate with 30 days	12 months
Postoperative nutrition status	Change of Hemoglobin, Vitamin B12 cumulative supplement quantity	12months

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 5, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: proximal gastrectomy, Cheng's Giraffe reconstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Esophagitis, Peptic; Esophagitis
• Other Study ID Numbers: 2020361093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No