Proximal Early Gastric CancerNCT06511609
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.
A study testing double-flap technique（DFT）; double-tract reconstruction(DTR), in people with Proximal Early Gastric Cancer, run by Changzhi People's Hospital Affiliated to Changzhi Medical College.
Trial summary
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Proximal Early Gastric Cancer
- What is being tested?
- double-flap technique（DFT）; double-tract reconstruction(DTR),
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2027
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 80 years, regardless of gender;
- Patients diagnosed with gastric cancer through tissue biopsy;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- American Society of Anesthesiologists (ASA) classification of I to III;
- Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:
- Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);
- Voluntary signing of informed consent.
Who cannot join
- Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- Presence of contraindications to surgery;
- Multiple malignant lesions in the stomach;
- Presence of other malignancies that may affect the preservation of stomach function;
- Previous upper abdominal surgery (excluding cholecystectomy);
- Preoperative examination reveals active peptic ulcer;
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- Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
- Pregnant or breastfeeding women;
- Conditions deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.
Read the detailed description
This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.
- Conditions
- Proximal Early Gastric Cancer
- Being tested
- double-flap technique（DFT）; double-tract reconstruction(DTR),
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double-flap technique（DFT）; double-tract reconstruction(DTR),Procedure or surgery
DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| double-flap technique（DFT） | Experimental | Laparoscopic proximal gastrectomy with double flap anastomosis group Receives: Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR), |
| double-tract reconstruction（DTR） | Active comparator | Laparoscopic proximal gastrectomy with double-tract anastomosis group Receives: Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with reflux esophagitis
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.
Measured: Within 12 months after surgery
Secondary outcomes (13)
Postoperative complications
Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.
Measured: Within 12 months after surgery
Operation time
From the beginning of surgery to the end of surgery
Measured: Perioperative period
Kamikawa anastomosis time
The time of making the seromuscular flap and the time of esophagogastrostomy were included
Measured: Perioperative period
intraoperative blood loss
The operation begins to end the amount of bleeding.
Measured: Perioperative period
Weight change
Calculated in kilograms
Measured: Within 12 months after surgery
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m^2
Measured: Within 12 months after surgery
Albumin value
The concentration of albumin in the blood, expressed in g/L.
Measured: Within 12 months after surgery
Pre albumin value
The concentration of pre albumin in the blood, expressed in g/L.
Measured: Within 12 months after surgery
Hemoglobin value
The concentration of Hemoglobin in the blood, expressed in g/L.
Measured: Within 12 months after surgery
Folic acid value
The concentration of Folic acid value in the blood, expressed in ng/mL.
Measured: Within 12 months after surgery
Vitamin B12 value
The concentration of Vitamin B12 value in the blood, expressed in uug/L.
Measured: Within 12 months after surgery
Ferritin value
The concentration of Vitamin B12 value in the blood, expressed in ug/L.
Measured: Within 12 months after surgery
Nutritional risk screening 2002
The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status.
Measured: Within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Early 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
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhi People's Hospital Affiliated to Changzhi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WenQing Hu, Study chair, 502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511609
- Sponsor's protocol ID
- CZPH-0001
- Status last verified
- May 2024
- First submitted
- 8 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06511609
- Acronym / sponsor ID
- CZPH-0001
- Conditions
- Proximal Early Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Changzhi People's Hospital Affiliated to Changzhi Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Jul 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.
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.
Detailed description
This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double-flap technique（DFT） | Experimental | Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),Laparoscopic proximal gastrectomy with double flap anastomosis group |
| double-tract reconstruction（DTR） | Active comparator | Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),Laparoscopic proximal gastrectomy with double-tract anastomosis group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 20 and 80 years, regardless of gender;
- Patients diagnosed with gastric cancer through tissue biopsy;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- American Society of Anesthesiologists (ASA) classification of I to III;
- Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:
Key exclusion criteria (9 listed)
- Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- Presence of contraindications to surgery;
- Multiple malignant lesions in the stomach;
- Presence of other malignancies that may affect the preservation of stomach function;
- Previous upper abdominal surgery (excluding cholecystectomy);
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 |
|---|---|---|
| double-flap technique（DFT）; double-tract reconstruction(DTR),DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy. | Procedure or surgery | double-flap technique（DFT）, double-tract reconstruction（DTR） |
Primary outcome
Proportion of patients with reflux esophagitis
Time frame: Within 12 months after surgery
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.
13 secondary outcomes
Postoperative complications
Time frame: Within 12 months after surgery
Operation time
Time frame: Perioperative period
Kamikawa anastomosis time
Time frame: Perioperative period
intraoperative blood loss
Time frame: Perioperative period
Weight change
Time frame: Within 12 months after surgery
Body Mass Index (BMI)
Time frame: Within 12 months after surgery
Albumin value
Time frame: Within 12 months after surgery
Pre albumin value
Time frame: Within 12 months after surgery
Hemoglobin value
Time frame: Within 12 months after surgery
Folic acid value
Time frame: Within 12 months after surgery
Vitamin B12 value
Time frame: Within 12 months after surgery
Ferritin value
Time frame: Within 12 months after surgery
Nutritional risk screening 2002
Time frame: Within 12 months 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 22 Jul 2024.
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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.
WenQing Hu study chair
502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China
Questions about this trial
What is this clinical trial studying?
A study testing double-flap technique（DFT）; double-tract reconstruction(DTR), in people with Proximal Early Gastric Cancer, run by Changzhi People's Hospital Affiliated to Changzhi Medical College.
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 7 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 WenQing Hu, Dr. (03552066898, beibeihejiyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with reflux esophagitis (time frame: Within 12 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 22 Jul 2024.