Proximal Gastric AdenocarcinomaNCT05829213
A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
A study testing "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy in people with Proximal Gastric Adenocarcinoma and Adenocarcinoma of Esophagogastric Junction, run by Peking University at 1 site in China.
Trial summary
The double-flap technique (DFT) is an effective digestive tract reconstruction method after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux esophagitis. But its clinical application is restricted due to the technical complexity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Proximal Gastric Adenocarcinoma, Adenocarcinoma of Esophagogastric Junction, Anastomosis
- What is being tested?
- "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Nov 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric junction
- diameter of the tumor less than 4cm
- ECOG performance status score ≤2
- no distant metastasis
- informed consent is signed
Who cannot join
- metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction
- remnant gastric cancer
- patient requires emergency surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ziyu Li
Beijing, Beijing Municipality, 100142
Ziyu Li, MD PHD, 0086-10-88196605, ziyu_li@hsc.pku.edu.cn
Yinkui Wang, MD PHD, 0086-10-88196606, wykchangfeng@pku.edu.cn
About this study
Official title: A Modified "Arch-bridge-type" Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
The double-flap technique (DFT) is an effective digestive tract reconstruction method after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux esophagitis. But its clinical application is restricted due to the technical complexity. Our surgical team devise a modified esophagogastric reconstructive method which we term the "arch-bridge-type" reconstruction based on the principle of DFT. The aim of this single-arm prospective study is to assess the safety and feasibility of the "arch-bridge-type" reconstruction after PG.
Read the detailed description
- The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines.
- Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.
- Creating the seromuscular flap ("arch-bridge"): (1) The stomach is resected by a linear stapling device. (2) A "匚" shaped seromuscularflap (3.0cm×4.0cm) is created utilizing electrocautery extracorporeally by dissecting submocosal and muscular layer of the anterior wall of the remnant stomach. (3) The opening of the flap is interrupted sutured by 4-0 absorbable suture, then the "arch-bridge" is created.
4.The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.
- Being tested
- "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"arch-bridge-type" esophagogastric reconstruction after proximal gastrectomyProcedure or surgery
- The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines
- Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.
- Creating the seromuscular flap ("arch-bridge")
- The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| "arch-bridge-type" reconstruction arm | Experimental | In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction. Receives: Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical safety
The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc.
Measured: From surgery day to 30 days after surgery
Postoperative long-term quality of life (QoL)
The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45.
Measured: 1 year after surgery
Secondary outcomes (4)
Postoperative body weight status
Body weight loss will be recorded in outpatient.
Measured: 1 year after surgery
Postoperative reflux esophagitis
Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification.
Measured: 1 year after surgery
Refinement of surgery
During the operation, the whole process of the operation will be videotaped by laparoscopy, and after the operation, the change of the technical process of the operation was judged by comparing the operation in the video and the scheduled operation steps before the operation. In case of technical changes, the surgical team will communicate and discuss with the chief surgeon, and decide whether to adjust and optimize the surgical technique based on the postoperative situation of the patient, so as to form new technical details. Objective metrics include the total operative time, the time of esophagogastric anastomosis, the time of creating the" arch-bridge", intraoperative blood loss, the number of retrieved lymph nodes will be collected.
Measured: From surgery day to 30 days after surgery
Postoperative hemoglobin
Laboratory tests will be done to evaluate the level of hemoglobin.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Nov 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Gastric AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziyu Li, MD, Peking University
- Investigators
- Ziyu Li, MD PHD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829213
- Sponsor's protocol ID
- 2023YJZ11
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 25 Apr 2023
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified "Arch-bridge-type" Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
- ClinicalTrials.gov ID
- NCT05829213
- Acronym / sponsor ID
- 2023YJZ11
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 25 Apr 2023 (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 double-flap technique (DFT) is an effective digestive tract reconstruction method after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux esophagitis. But its clinical application is restricted due to the technical complexity. Our surgical team devise a modified esophagogastric reconstructive method which we term the "arch-bridge-type" reconstruction based on the principle of DFT. The aim of this single-arm prospective study is to assess the safety and feasibility of the "arch-bridge-type" reconstruction after PG.
Detailed description
- The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines.
- Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.
- Creating the seromuscular flap ("arch-bridge"): (1) The stomach is resected by a linear stapling device. (2) A "匚" shaped seromuscularflap (3.0cm×4.0cm) is created utilizing electrocautery extracorporeally by dissecting submocosal and muscular layer of the anterior wall of the remnant stomach. (3) The opening of the flap is interrupted sutured by 4-0 absorbable suture, then the "arch-bridge" is created.
4.The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "arch-bridge-type" reconstruction arm | Experimental | Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomyIn this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric junction
- diameter of the tumor less than 4cm
- ECOG performance status score ≤2
- no distant metastasis
- informed consent is signed
Key exclusion criteria (3 listed)
- metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction
- remnant gastric cancer
- patient requires emergency surgery
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 |
|---|---|---|
| "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines 2. Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. 3. Creating the seromuscular flap ("arch-bridge") 4. The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis. | Procedure or surgery | "arch-bridge-type" reconstruction arm |
Primary outcome
Surgical safety
Time frame: From surgery day to 30 days after surgery
The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc.
Postoperative long-term quality of life (QoL)
Time frame: 1 year after surgery
The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45.
4 secondary outcomes
Postoperative body weight status
Time frame: 1 year after surgery
Postoperative reflux esophagitis
Time frame: 1 year after surgery
Refinement of surgery
Time frame: From surgery day to 30 days after surgery
Postoperative hemoglobin
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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. This study is not recruiting at the moment.
Ziyu Li, MD PHD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy in people with Proximal Gastric Adenocarcinoma and Adenocarcinoma of Esophagogastric Junction, run by Peking University 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 5 inclusion and 3 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 25 Apr 2023. 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 Yinkui Wang, MD PHD (0086-10-88196606, wykchangfeng@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical safety (time frame: From surgery day to 30 days after surgery). The study lists 2 primary outcomes in all. 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 25 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.