Anti-Reflux Alimentary ReconstructionNCT06347757
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy
A study testing Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy in people with Anti-Reflux Alimentary Reconstruction and Laparoscopic Proximal Gastrectomy, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anti-Reflux Alimentary Reconstruction, Laparoscopic Proximal Gastrectomy, Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction
- What is being tested?
- Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 15 Mar 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
- Age between 18-75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
- American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
- 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) (14) according to the eighth edition of the AJCC;
- Patients without contraindications to surgery;
- Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;
Who cannot join
- Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
- Combined resection required due to other diseases (except cholecystectomy).
- History of cancer or concurrent cancer in other organs.
- Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
- Patients with coagulation dysfunction which could not be corrected;
- Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
- Receipt of chemotherapy or radiotherapy before either surgical procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols (Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction) After Laparoscopic Proximal Gastrectomy
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
Read the detailed description
In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.
- Conditions
- Anti-Reflux Alimentary Reconstruction, Laparoscopic Proximal Gastrectomy, Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction
- Being tested
- Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal GastrectomyProcedure or surgery
laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR).
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction | Experimental | Not described Receives: Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy |
| laparoscopic proximal gastrectomy with double-tract reconstruction | Active comparator | Not described Receives: Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy |
| laparoscopic proximal gastrectomy with tube-like stomach reconstruction | Active comparator | Not described Receives: Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reflux esophagitis
Measured: At 1 year after LPG
Secondary outcomes (5)
Incidence of anastomotic leakage
Measured: At 1 year after LPG
Incidence of anastomotic stenosis
Measured: At 1 year after LPG
Operative time
Measured: Intraoperative
Intra-operative blood loss
Measured: Intraoperative
Overall survival, and disease-free survival
Measured: At 1 and 3 years after LPG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-Reflux Alimentary ReconstructionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daorong Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347757
- Sponsor's protocol ID
- NorthernJiangsuhospital1
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian Z, Cheng Y, Wang Y, Ren J, Wang S, Wang D. A 3-Arm case-matched analysis of anti-reflux reconstruction methods after laparoscopic proximal gastrectomy - Single tract jejunal interposition vs double tract reconstruction vs tube-like stomach reconstruction. Eur J Surg Oncol. 2025 Feb;51(2):109482. doi: 10.1016/j.ejso.2024.109482. Epub 2024 Nov 19.
PubMed 39580964
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols (Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction) After Laparoscopic Proximal Gastrectomy
- ClinicalTrials.gov ID
- NCT06347757
- Acronym / sponsor ID
- NorthernJiangsuhospital1
- Conditions
- Anti-Reflux Alimentary Reconstruction, Laparoscopic Proximal Gastrectomy, Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Apr 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 efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
Detailed description
In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction | Experimental | Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy |
| laparoscopic proximal gastrectomy with double-tract reconstruction | Active comparator | Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy |
| laparoscopic proximal gastrectomy with tube-like stomach reconstruction | Active comparator | Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
- American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
- 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) (14) according to the eighth edition of the AJCC;
- Patients without contraindications to surgery;
Key exclusion criteria (7 listed)
- Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
- Combined resection required due to other diseases (except cholecystectomy).
- History of cancer or concurrent cancer in other organs.
- Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
- Patients with coagulation dysfunction which could not be corrected;
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 |
|---|---|---|
| Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomylaparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR). | Procedure or surgery | laparoscopic proximal gastrectomy with double-tract reconstruction, laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction, laparoscopic proximal gastrectomy with tube-like stomach reconstruction |
Primary outcome
Incidence of reflux esophagitis
Time frame: At 1 year after LPG
5 secondary outcomes
Incidence of anastomotic leakage
Time frame: At 1 year after LPG
Incidence of anastomotic stenosis
Time frame: At 1 year after LPG
Operative time
Time frame: Intraoperative
Intra-operative blood loss
Time frame: Intraoperative
Overall survival, and disease-free survival
Time frame: At 1 and 3 years after LPG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 39580964Tian Z, Cheng Y, Wang Y, Ren J, Wang S, Wang D. A 3-Arm case-matched analysis of anti-reflux reconstruction methods after laparoscopic proximal gastrectomy - Single tract jejunal interposition vs double tract reconstruction vs tube-like stomach reconstruction. Eur J Surg Oncol. 2025 Feb;51(2):109482. doi: 10.1016/j.ejso.2024.109482. Epub 2024 Nov 19.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy in people with Anti-Reflux Alimentary Reconstruction and Laparoscopic Proximal Gastrectomy, run by Northern Jiangsu People's 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: finished, as of the sponsor's last update on 30 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reflux esophagitis (time frame: At 1 year after LPG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06347757, which also lists 1 linked publication.
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 30 Apr 2024.