Gastric Cancer (GC)NCT07117812
Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy
A study testing Laparoscopic purse-string forceps and multifunctional sealing ring in people with Gastric Cancer (GC) and Gastrectomy, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer (GC), Gastrectomy, Anastomosis, Roux-en-Y
- What is being tested?
- Laparoscopic purse-string forceps and multifunctional sealing ring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, regardless of gender; Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ cancer, only Siewert type III and type II (without requiring thoracotomy) are eligible (applicable to multiple primary cancers); Preoperative assessment by a gastrointestinal surgeon and imaging specialist confirming cStage I-III disease with eligibility for curative-intent R0 resection. Patient consents to surgery and is deemed surgically fit by the surgeon; Anticipated R0 resection achievable via total gastrectomy with D1+/D2 lymphadenectomy; Expected survival ≥6 months; ECOG Performance Status (PS) score (see Appendix 2) of 0 or 1; Adequate major organ function; Body weight ≥40 kg or BMI >18.5 and <30 kg/m²; No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy; Patient has read and fully understood the informed consent form and voluntarily signed it
Who cannot join
- History of other active malignancies within the past 5 years or concurrent malignancies (except cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate/cervix/breast, Stage I lung/colorectal cancer, etc.).
- Previous upper abdominal surgery (excluding laparoscopic cholecystectomy). History of gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
- Requirement for concurrent surgery for other diseases. Emergency surgery due to gastric cancer complications (bleeding, obstruction, or perforation).
- Planned or prior organ/bone marrow transplantation. Blood transfusion within 2 weeks before surgery, bleeding history, or Grade ≥3 hemorrhage (CTCAE v4.0) within 4 weeks.
- Coagulopathy (INR >1.5 without anticoagulants) or use of anticoagulants (warfarin/heparin). Prophylactic low-dose warfarin (≤1 mg/day) or aspirin (≤100 mg/day) is permitted if INR ≤1.5.
- Arterial/venous thrombosis within 6 months (e.g., stroke, DVT, pulmonary embolism), excluding catheter-related thrombosis from prior chemotherapy.
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- Myocardial infarction within 6 months or uncontrolled arrhythmia (QTc ≥450 ms [men]/≥470 ms [women] by Fridericia's formula).
- NYHA Class III-IV heart failure or LVEF <50%. Ventilatory dysfunction (FEV1 <50% predicted). Urinary protein ≥++ or 24-hour urine protein >1.0 g. Clinically significant pleural/peritoneal effusion requiring intervention. HIV infection. Active tuberculosis. Non-healing wounds or incomplete fracture healing. Active/suspected autoimmune disease (stable cases without immunosuppressants allowed).
- Severe autoimmune diseases (e.g., SLE, IBD), chronic diarrhea disorders, or active HBV/HCV (HBV DNA <500 copies/mL permitted).
- Systemic corticosteroids (>10 mg/day prednisone equivalent) within 14 days (topical/inhaled steroids or physiologic replacement doses allowed).
- Active infection requiring systemic antibiotics within 14 days (prophylactic antibiotics permitted).
- Live vaccines within 28 days (inactivated flu vaccines allowed). Concurrent participation in another surgical trial. Alcohol/drug abuse history (abstinent patients eligible). Non-compliance or incomplete data affecting safety/efficacy assessments. Pregnancy/lactation. Other conditions deemed high-risk by investigators. Investigator-determined ineligibility.
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
Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established.
Hand-sewn anastomosis relies on advanced endoscopic suturing skills, making it technically demanding and only performed in a limited number of hospitals.
Read more
Linear anastomosis is simple to perform and the most widely used in clinical practice. However, it requires resection of a longer segment of the distal esophagus and may struggle to ensure adequate margins for high-positioned tumors or unclear resection boundaries.
Circular anastomosis is a classic method. Its end-to-side approach preserves more esophageal length, making it suitable for high-positioned tumors without the need to close a common opening. Various techniques (e.g., the reverse-puncture method and the Orvil™ transoral anvil technique) have been reported. However, due to challenges such as purse-string suturing, complex anvil placement, and restricted stapler maneuverability, widespread adoption remains difficult.
Prof. Du Jianjun's team innovatively employed endoscopic purse-string forceps and a multifunctional sealing ring to achieve circular anastomosis, demonstrating preliminary technical advantages. This study further explores its feasibility and short-term outcomes in totally endoscopic total gastrectomy.
- Conditions
- Gastric Cancer (GC), Gastrectomy, Anastomosis, Roux-en-Y, Laparoscopic
- Being tested
- Laparoscopic purse-string forceps and multifunctional sealing ring
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic purse-string forceps and multifunctional sealing ringProcedure or surgery
Also called LPSF and MSR
Performing totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Roux-en-Y esophagojejunostomy using purse-string forceps and sealing ring | Experimental | Performing totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring. Receives: Procedure: Laparoscopic purse-string forceps and multifunctional sealing ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative complications
Early postoperative complications were defined as adverse events occurring within 30 days after surgery. All complications were classified according to the Clavien-Dindo grading system and recorded numerically.
Measured: 30 days
Secondary outcomes (2)
Postoperative recovery situation
The time of first getting out of bed after surgery, the time of postoperative ventilation, the time of liquid diet after surgery, the time of soft food after surgery, the length of hospital stay after surgery, and the total amount of abdominal drainage; The changes of albumin, prealbumin, white blood cells, hemoglobin, C-reactive protein, IL-6, etc. in the peripheral blood after surgery.
Measured: 30 days
Late postoperative complications
Events observed from day 31 to month 24 after surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117812
- Sponsor's protocol ID
- 2025-SR-633
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy
- ClinicalTrials.gov ID
- NCT07117812
- Acronym / sponsor ID
- 2025-SR-633
- Conditions
- Gastric Cancer (GC), Gastrectomy, Anastomosis, Roux-en-Y, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established.
Hand-sewn anastomosis relies on advanced endoscopic suturing skills, making it technically demanding and only performed in a limited number of hospitals.
Linear anastomosis is simple to perform and the most widely used in clinical practice. However, it requires resection of a longer segment of the distal esophagus and may struggle to ensure adequate margins for high-positioned tumors or unclear resection boundaries.
Circular anastomosis is a classic method. Its end-to-side approach preserves more esophageal length, making it suitable for high-positioned tumors without the need to close a common opening. Various techniques (e.g., the reverse-puncture method and the Orvil™ transoral anvil technique) have been reported. However, due to challenges such as purse-string suturing, complex anvil placement, and restricted stapler maneuverability, widespread adoption remains difficult.
Prof. Du Jianjun's team innovatively employed endoscopic purse-string forceps and a multifunctional sealing ring to achieve circular anastomosis, demonstrating preliminary technical advantages. This study further explores its feasibility and short-term outcomes in totally endoscopic total gastrectomy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Roux-en-Y esophagojejunostomy using purse-string forceps and sealing ring | Experimental | Procedure: Laparoscopic purse-string forceps and multifunctional sealing ringPerforming totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years, regardless of gender; Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ cancer, only Siewert type III and type II (without requiring thoracotomy) are eligible (applicable to multiple primary cancers); Preoperative assessment by a gastrointestinal surgeon and imaging specialist confirming cStage I-III disease with eligibility for curative-intent R0 resection. Patient consents to surgery and is deemed surgically fit by the surgeon; Anticipated R0 resection achievable via total gastrectomy with D1+/D2 lymphadenectomy; Expected survival ≥6 months; ECOG Performance Status (PS) score (see Appendix 2) of 0 or 1; Adequate major organ function; Body weight ≥40 kg or BMI >18.5 and <30 kg/m²; No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy; Patient has read and fully understood the informed consent form and voluntarily signed it
Key exclusion criteria (12 listed)
- History of other active malignancies within the past 5 years or concurrent malignancies (except cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate/cervix/breast, Stage I lung/colorectal cancer, etc.).
- Previous upper abdominal surgery (excluding laparoscopic cholecystectomy). History of gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
- Requirement for concurrent surgery for other diseases. Emergency surgery due to gastric cancer complications (bleeding, obstruction, or perforation).
- Planned or prior organ/bone marrow transplantation. Blood transfusion within 2 weeks before surgery, bleeding history, or Grade ≥3 hemorrhage (CTCAE v4.0) within 4 weeks.
- Coagulopathy (INR >1.5 without anticoagulants) or use of anticoagulants (warfarin/heparin). Prophylactic low-dose warfarin (≤1 mg/day) or aspirin (≤100 mg/day) is permitted if INR ≤1.5.
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 |
|---|---|---|
| Laparoscopic purse-string forceps and multifunctional sealing ringAlso: LPSF and MSRPerforming totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring. | Procedure or surgery | Laparoscopic Roux-en-Y esophagojejunostomy using purse-string forceps and sealing ring |
Primary outcome
Early postoperative complications
Time frame: 30 days
Early postoperative complications were defined as adverse events occurring within 30 days after surgery. All complications were classified according to the Clavien-Dindo grading system and recorded numerically.
2 secondary outcomes
Postoperative recovery situation
Time frame: 30 days
Late postoperative complications
Time frame: 2 years
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 15 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic purse-string forceps and multifunctional sealing ring in people with Gastric Cancer (GC) and Gastrectomy, run by The First Affiliated Hospital with Nanjing Medical University.
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 1 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: opening soon, as of the sponsor's last update on 15 Aug 2025. 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 Yawei Qian, Ph.D. (+8615365083368, ywess1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative complications (time frame: 30 days). 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 15 Aug 2025.