Comparison of Safety and Clinical Effects of Straight and Articulated Instruments (ArtiSential) in Laparoscopic Gastrectomy for Gastric Cancer Patients, a Prospective Randomized Study

NCT07100431 | Completed

• 1 other identifier: 3-2022-0165
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with gastric cancer, gastrectomy can be performed via laparoscopic/robotic or open surgery. It is crucial to completely remove the tumor along with an adequate extent of lymph node dissection. The number of lymph nodes retrieved during gastrectomy is considered an important factor associated with the quality of the surgery and can serve as an indicator of the completeness of the procedure. In particular, during the dissection of lymph node stations 8, 9, 11p and 12a - which are located near the superior aspect of the pancreas - pressure is often applied to the pancreas to secure an adequate surgical view. Recent studies have suggested that this may be associated with postoperative pancreatic complications. It is believed that the use of articulating instruments during laparoscopic gastrectomy may enable a safer dissection of lymph nodes located above the pancreas. However, to date, there have been lack of studies comparing the safety and efficacy of articulating versus straight instruments in laparoscopic gastrectomy. Therefore, this study aims to analyze the compare these two approaches.

Conditions

Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy

Outcome Measures

Primary Outcomes (1)

• The reduction in operative time achieved by using an articulating instrument for dissection of suprapancreatic lymph nodes during laparoscopic gastrectomy

  To confirm that the use of articulating instruments in radical gastrectomy can lead to more efficient and safer surgery compared to conventional straight instruments.

  During surgery, the total operation time, and the supra-pancreatic lymph node dissection time will be calculated respectively. The supra-pancreatic lymph node dissection time will be measured from the point of right gastric artery ligation to just before

Secondary Outcomes (3)

• The degree of pancreas injury after surgery

  Amylase levels will be measured in serum and peritoneal fluid on postoperative day 1 and 3.

• Estimated blood loss

  Estimated blood loss will be calculated during surgery.

• The number of retrieved lymph nodes

  The number of retrieved lymph nodes were counted after surgery

Study Arms (2)

Articulating group

EXPERIMENTAL

During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with an articulating laparoscopic instrument (ArtiSential®, LIVSMED, Maryland jaw) in their left hand.

Procedure: Articulating (experimental group); Procedure: Control (control group)

Control group

NO INTERVENTION

During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with a conventional straight laparoscopic instrument in their left hand.

Interventions

Articulating (experimental group) PROCEDURE

1\. Surgical procedure On the day of surgery, random allocation to either the experimental or the control group will be perfored just before the start of the procedure. All of the surgery will be conducted laparoscopically. The control group will undergo surgery using a conventional straight laparoscopic instrument, while the experimental group will use an articulating instrument. The surgical procedure will be the same for both groups. The total time of surgery and the time spent on the supra-pancreatic lymph node dissection will be recorded during the procedure. The estimated blood loss during surgery will be also measured.

Articulating group

Control (control group) PROCEDURE

2\. Postoperative follow-up Patients participating in this study will have the same postoperative care as those not participating in this study. To compare the degree of pancreatic injury, amylase and lipase levels will be measured in the serum and the peritoneal fluid frome the drainage on postoperative days 1 and 3. Postoperative complications will be classified and recorded according to the Clavien-Dindo classification for all complications occurring within 30 days after surgery. The dissected lymph nodes will be categorized by region, and the number of dissected lymph nodes will also be confirmed.

Articulating group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with gastric adenocarcinoma pathologically before surgery
• Patients scheduled for laparoscopic radical gastrectomy
• Patients aged more than 20
• Patients with an ECOG 0 or 1

You may not qualify if:

• Patients with a history of gastrectomy
• Patients with a history of pancreatitis or pancreatic surgery
• Patients with a history of abdominal surgery who are expected to have severe intra-abdominal adhesions
• Patients scheduled for total gastrectomy with D2 lymph node dissection

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were randomly assigned in a 1:1 ratio to two groups; the control group or the experimental (Articulating) group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: During supra-pancreatic lymph node dissection, the assistant provides downward traction on the pancreas head with an instrument in their left hand to secure a clear surgical view. In the Control group, a conventional straight laparoscopic instrument was used for this purpose, while in the Articulating group, an articulating laparoscopic instrument (ArtiSential®, LIVSMED, Maryland jaw) was used.

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: June 22, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 31, 2023
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

KR (1)