Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap fo… (NCT07117812) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy
50 participantsStarted 2025-09-01
Plain-language 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.
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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. E…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early postoperative complications
Timeframe: 30 days
Trial details
NCT IDNCT07117812
SponsorThe First Affiliated Hospital with Nanjing Medical University