Gastric CancerNCT06300879
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
A study testing Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique in people with Gastric Cancer and Adenocarcinoma of Esophagogastric Junction, run by Huashan Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
- 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 Jan 2024to 30 Jun 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old;
- Pathologically confirmed as adenocarcinoma;
- Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
- If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
- For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
- Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
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- No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
- No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
- Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
- Preoperative ASA (American Society of Anesthesiologists) score I-III.
- Good function of important organs.
- Signed informed consent.
Who cannot join
- Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
- Pregnant or lactating women;
- Patients with severe mental illness;
- Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
- Severe respiratory diseases, with FEV1 < 50% of predicted value;
- History of other malignant tumors in the past 5 years;
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- Severe liver or kidney dysfunction;
- Unstable angina or myocardial infarction within the last 6 months;
- History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
- Systemic use of glucocorticoids within the last 1 month;
- Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
- Patient has participated in or is currently participating in other clinical trials (within the last 6 months).
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, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Hankun Hao, doctor, +86 18121186328, haohankun@163.com
About this study
Official title: A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).
The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
- Being tested
- Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
- Keywords
- proximal gastrectomy, totally laparoscopic gastrectomy, fissure technique
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure techniqueProcedure or surgery
Surgical Operation:
- Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach.
- Lymph Node Dissection Range:D1+ to D2 lymph node dissection.
- Anastomosis Method: esophagogastrostomy by fissure technique.
- Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis.
- Surgical Approach:Totally laparoscopic proximal gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique Receives: Procedure: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess intraoperative Perioperative Safety by Duration of surgery.
Time spent on the whole operation（minutes）
Measured: intraoperative
Assess intraoperative Perioperative Safety by Duration of anastomosis.
Time spent on the anastomosis in minutes
Measured: intraoperative
Assess intraoperative Perioperative Safety by blood loss .
Intraoperative blood loss in milliliters
Measured: intraoperative
Postoperative recovery course
Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Measured: 30 days after the surgery
Postoperative TNM staging by Pathological findings .
AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor .
Measured: 30 days after the surgery
Secondary outcomes (4)
The incidence of postoperative reflux esophagitis
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Measured: 3 months after surgery
The incidence of postoperative anastomotic stenosis
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Measured: 3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30
QLQ-C30 is a comprehensive assessment of the overall quality of life dimensions before and after surgery for patients. Higher scores represent poorer quality of life for patients after surgery.
Measured: 3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale
QLQ-STO22 is a specific assessment for postoperative situations related to anastomosis, such as swallowing and eating.Higher scores represent poorer quality of life for patients after surgery.
Measured: 3 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 posted8 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (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 Huashan 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
- Model description
- Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Hankun, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300879
- Sponsor's protocol ID
- 2023-1058
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique
- ClinicalTrials.gov ID
- NCT06300879
- Acronym / sponsor ID
- 2023-1058
- Keywords
- proximal gastrectomy, totally laparoscopic gastrectomy, fissure technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Mar 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 is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).
The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure techniquePerforming totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 years old;
- Pathologically confirmed as adenocarcinoma;
- Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
- If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
- For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
Key exclusion criteria (12 listed)
- Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
- Pregnant or lactating women;
- Patients with severe mental illness;
- Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
- Severe respiratory diseases, with FEV1 < 50% of predicted value;
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 |
|---|---|---|
| Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure techniqueSurgical Operation: 1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. 2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. 3. Anastomosis Method: esophagogastrostomy by fissure technique. 4. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis. 5. Surgical Approach:Totally laparoscopic proximal gastrectomy. | Procedure or surgery | Experimental group |
Primary outcome
Assess intraoperative Perioperative Safety by Duration of surgery.
Time frame: intraoperative
Time spent on the whole operation（minutes）
Assess intraoperative Perioperative Safety by Duration of anastomosis.
Time frame: intraoperative
Time spent on the anastomosis in minutes
Assess intraoperative Perioperative Safety by blood loss .
Time frame: intraoperative
Intraoperative blood loss in milliliters
Postoperative recovery course
Time frame: 30 days after the surgery
Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Postoperative TNM staging by Pathological findings .
Time frame: 30 days after the surgery
AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor .
4 secondary outcomes
The incidence of postoperative reflux esophagitis
Time frame: 3 months after surgery
The incidence of postoperative anastomotic stenosis
Time frame: 3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30
Time frame: 3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale
Time frame: 3 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 2 May 2025.
- 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 Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique in people with Gastric Cancer and Adenocarcinoma of Esophagogastric Junction, run by Huashan 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess intraoperative Perioperative Safety by Duration of surgery. (time frame: intraoperative). The study lists 5 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 2 May 2025.