Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy
Primary Purpose
Gastric Cancer, Reflux Esophagitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
proximal gastrectomy combined with Cheng's Giraffe reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring proximal gastrectomy, Cheng's Giraffe reconstruction
Eligibility Criteria
Inclusion Criteria:
- Preoperative endoscopy and biopsy confirmed adenocarcinoma of esophagogastric junction, and predictively feasible of transabdominal proximal gastrectomy.
- Early gastric cancer, of preoperative staging AJCC 8th Edition cT1N0M0 and not suitable for endoscopic resection;
- Completion of abdominal CT scan and ultrasound endoscopy
- Age:18 to 70 years ;
- Karnofsky score ≥ 70
- With good compliance and informed consent required.
Exclusion Criteria:
- Pregnancy, breast-feeding women.
- The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
- Severity mental diseases;
- 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.
- With other malignancies which were not cured.
- Patients have already joined other clinical trials
- After signature the Clinical trial agreement, patients and their agent will quit the trial.
Sites / Locations
- Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
proximal gastrectomy combined with Cheng's Giraffe reconstruction
Arm Description
proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Postoperative recovery
postoperative complication rate according to the Clavian-Dindo classification, postoperative death rate with 30 days
Postoperative nutrition status
Change of Hemoglobin, Vitamin B12 cumulative supplement quantity
Full Information
NCT ID
NCT04657848
First Posted
November 24, 2020
Last Updated
December 5, 2020
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04657848
Brief Title
Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy
Official Title
Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy in Early Adenocarcinoma of Esophagogastric Junction : A Prospective Open-label Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Reflux Esophagitis
Keywords
proximal gastrectomy, Cheng's Giraffe reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
proximal gastrectomy combined with Cheng's Giraffe reconstruction
Arm Type
Experimental
Arm Description
proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)
Intervention Type
Procedure
Intervention Name(s)
proximal gastrectomy combined with Cheng's Giraffe reconstruction
Intervention Description
proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)
Primary Outcome Measure Information:
Title
Rate of reflux esophagitis after operation
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Postoperative quality of life: European Organization for Research and Treatment of Cancer (EORTC)
Description
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.
Time Frame
12 months
Title
Postoperative recovery
Description
postoperative complication rate according to the Clavian-Dindo classification, postoperative death rate with 30 days
Time Frame
12 months
Title
Postoperative nutrition status
Description
Change of Hemoglobin, Vitamin B12 cumulative supplement quantity
Time Frame
12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preoperative endoscopy and biopsy confirmed adenocarcinoma of esophagogastric junction, and predictively feasible of transabdominal proximal gastrectomy.
Early gastric cancer, of preoperative staging AJCC 8th Edition cT1N0M0 and not suitable for endoscopic resection;
Completion of abdominal CT scan and ultrasound endoscopy
Age:18 to 70 years ;
Karnofsky score ≥ 70
With good compliance and informed consent required.
Exclusion Criteria:
Pregnancy, breast-feeding women.
The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
Severity mental diseases;
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.
With other malignancies which were not cured.
Patients have already joined other clinical trials
After signature the Clinical trial agreement, patients and their agent will quit the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangdong Cheng, MD
Phone
+86-05714758155013
Email
zyq201003@163.com
Facility Information:
Facility Name
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Cheng, MD
Phone
+86-05714758155013
Email
zyq201003@163.com
12. IPD Sharing Statement
Learn more about this trial
Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy
We'll reach out to this number within 24 hrs