Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy

NCT07117812 | Not Yet Recruiting

• 1 other identifier: 2025-SR-633
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer (GC); Gastrectomy; Anastomosis, Roux-en-Y; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (2)

• Postoperative recovery situation

  30 days

• Late postoperative complications

  2 years

Study Arms (1)

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.

Procedure: Laparoscopic purse-string forceps and multifunctional sealing ring

Interventions

Laparoscopic purse-string forceps and multifunctional sealing ring PROCEDURE

Performing totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring.

Also known as: LPSF and MSR

Laparoscopic Roux-en-Y esophagojejunostomy using purse-string forceps and sealing ring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

methionine synthase reductase

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yawei Qian, Ph.D.

CONTACT

+8615365083368; ywess1990@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08