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

NCT04657848 | Unknown

• 1 other identifier: 2020361093
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Reflux Esophagitis

Keywords

proximal gastrectomy, Cheng's Giraffe reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative quality of life: European Organization for Research and Treatment of Cancer (EORTC)

  12 months

• Postoperative recovery

  12 months

• Postoperative nutrition status

  12months

Study Arms (1)

proximal gastrectomy combined with Cheng's Giraffe reconstruction

EXPERIMENTAL

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

Interventions

proximal gastrectomy combined with Cheng's Giraffe reconstruction PROCEDURE

proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)

proximal gastrectomy combined with Cheng's Giraffe reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, 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

Xiangdong Cheng, MD

CONTACT

+86-05714758155013; zyq201003@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 8, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2023
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

CN (1)