Gastric CancerNCT06741501
Preliminary Efficacy Analysis of "C" Single Flap Plasty Reconstruction After Laparoscopic Proximal Gastrectomy
A study testing "C" Single Flap Plasty Reconstruction and Normal Reconstruction in people with Gastric Cancer and Reflux Esophagitis, run by Daorong Wang at 1 site in China.
Trial summary
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Reflux Esophagitis
- What is being tested?
- "C" Single Flap Plasty Reconstruction and Normal Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-80 years old, male or female;
- Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) according to the eighth edition of the AJCC ;
- No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT;
- ASA grade 1-3;
- Patients without contraindications to surgery;
- Patients and their families voluntarily signed the informed consent form and participated in the study;
Who cannot join
- Patients diagnosed with primary tumors or distant metastasis;
- Patients whose tumor is located in the greater curvature side of the stomach;
- Patients with coagulation dysfunction that could not be corrected;
- Patients who were diagnosed with viral hepatitis and cirrhosis;
- Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
- Patients with organ failure such as heart, lung, liver, brain, and kidney failure;
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- Patients with ascites or cachexia preoperatively in poor general conditions;
- Patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
- Patients refusing to sign the informed consent of the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Daorong Wang, doctor, 0514-87373114, wdaorong666@sina.com
About this study
Official title: Laparoscopic Proximal Gastrectomy with "C" Single Flap Plasty Reconstruction for Upper-Third Gastric Cancer: a Randomized Clinical Trial.
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, we propose a reconstruction called the "C" Single Flap Plasty Reconstruction. This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "C" Single Flap Plasty Reconstruction in the treatment of gastric cancer.
- Conditions
- Gastric Cancer, Reflux Esophagitis
- Being tested
- "C" Single Flap Plasty Reconstruction, Normal 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.
"C" Single Flap Plasty ReconstructionProcedure or surgery
- C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux.
Normal ReconstructionProcedure or surgery
- Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques.
| Study group | Role | What they receive |
|---|---|---|
| "C" Single Flap Plasty Reconstruction | Experimental | 1. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site.
2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed.
3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux. Receives: Procedure: "C" Single Flap Plasty Reconstruction |
| Normal Reconstruction | Active comparator | 1. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall.
2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques. Receives: Procedure: Normal Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
Measured: 6 months after surgery
Secondary outcomes (1)
incidence of anastomotic leakage
The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daorong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daorong Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741501
- Sponsor's protocol ID
- northernjiangsu007
- Status last verified
- Dec 2024
- First submitted
- 13 Oct 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Proximal Gastrectomy with "C" Single Flap Plasty Reconstruction for Upper-Third Gastric Cancer: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06741501
- Acronym / sponsor ID
- northernjiangsu007
- Conditions
- Gastric Cancer, Reflux Esophagitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Daorong WangUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Dec 2024 (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.
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, we propose a reconstruction called the "C" Single Flap Plasty Reconstruction. This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "C" Single Flap Plasty Reconstruction in the treatment of gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "C" Single Flap Plasty Reconstruction | Experimental | Procedure: "C" Single Flap Plasty Reconstruction1. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux. |
| Normal Reconstruction | Active comparator | Procedure: Normal Reconstruction1. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-80 years old, male or female;
- Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) according to the eighth edition of the AJCC ;
- No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT;
- ASA grade 1-3;
- Patients without contraindications to surgery;
Key exclusion criteria (9 listed)
- Patients diagnosed with primary tumors or distant metastasis;
- Patients whose tumor is located in the greater curvature side of the stomach;
- Patients with coagulation dysfunction that could not be corrected;
- Patients who were diagnosed with viral hepatitis and cirrhosis;
- Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
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 |
|---|---|---|
| "C" Single Flap Plasty Reconstruction1. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux. | Procedure or surgery | "C" Single Flap Plasty Reconstruction |
| Normal Reconstruction1. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques. | Procedure or surgery | Normal Reconstruction |
Primary outcome
incidence of reflux esophagitis
Time frame: 6 months after surgery
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
1 secondary outcome
incidence of anastomotic leakage
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "C" Single Flap Plasty Reconstruction and Normal Reconstruction in people with Gastric Cancer and Reflux Esophagitis, run by Daorong Wang 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 9 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: opening soon, as of the sponsor's last update on 19 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daorong Wang, doctor (8618051062590, wdaorong666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of reflux esophagitis (time frame: 6 months after surgery). 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 19 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.