Gastric CancerNCT04657848
Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy
A study testing proximal gastrectomy combined with Cheng's Giraffe reconstruction in people with Gastric Cancer and Reflux Esophagitis, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Reflux Esophagitis
- What is being tested?
- proximal gastrectomy combined with Cheng's Giraffe reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310000
Xiangdong Cheng, MD, +86-05714758155013, zyq201003@163.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Gastric Cancer, Reflux Esophagitis
- Being tested
- proximal gastrectomy combined with Cheng's Giraffe reconstruction
- Keywords
- proximal gastrectomy, Cheng's Giraffe reconstruction
- Medical subject headings
- Stomach Neoplasms, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal gastrectomy combined with Cheng's Giraffe reconstructionProcedure or surgery
proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: proximal gastrectomy combined with Cheng's Giraffe reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
Postoperative recovery
postoperative complication rate according to the Clavian-Dindo classification, postoperative death rate with 30 days
Measured: 12 months
Postoperative nutrition status
Change of Hemoglobin, Vitamin B12 cumulative supplement quantity
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657848
- Sponsor's protocol ID
- 2020361093
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy Analysis of Cheng's Giraffe Reconstruction After Proximal Gastrectomy in Early Adenocarcinoma of Esophagogastric Junction : A Prospective Open-label Study
- ClinicalTrials.gov ID
- NCT04657848
- Acronym / sponsor ID
- 2020361093
- Conditions
- Gastric Cancer, Reflux Esophagitis
- Keywords
- proximal gastrectomy, Cheng's Giraffe reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proximal gastrectomy combined with Cheng's Giraffe reconstruction | Experimental | Procedure: proximal gastrectomy combined with Cheng's Giraffe reconstructionproximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proximal gastrectomy combined with Cheng's Giraffe reconstructionproximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction) | Procedure or surgery | proximal gastrectomy combined with Cheng's Giraffe reconstruction |
Primary outcome
Rate of reflux esophagitis after operation
Time frame: 12 months
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.
3 secondary outcomes
Postoperative quality of life: European Organization for Research and Treatment of Cancer (EORTC)
Time frame: 12 months
Postoperative recovery
Time frame: 12 months
Postoperative nutrition status
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proximal gastrectomy combined with Cheng's Giraffe reconstruction in people with Gastric Cancer and Reflux Esophagitis, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangdong Cheng, MD (+86-05714758155013, zyq201003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reflux esophagitis after operation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.