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

August 12, 2025 updated by: Li Yang, The First Affiliated Hospital with Nanjing Medical University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Roux-en-Y esophagojejunostomy using purse-string forceps and sealing ring
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
Performing totally laparoscopic radical total gastrectomy with R0 resection, completing esophagojejunostomy using purse-string forceps and multifunctional sealing ring.
Other Names:
  • LPSF and MSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative recovery situation
Time Frame: 30 days
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.
30 days
Late postoperative complications
Time Frame: 2 years
Events observed from day 31 to month 24 after surgery.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 5, 2025

First Submitted That Met QC Criteria

August 5, 2025

First Posted (Actual)

August 12, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-SR-633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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