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OpenTrials
Completed

NCT Number: NCT07100431

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

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.

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Key information

Conditions

Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Articulating (experimental group)

Procedure
  • 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.

Control (control group)

Procedure
  • 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.

Primary outcomes

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

    Time frame: 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

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

Secondary outcomes

  1. The degree of pancreas injury after surgery

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

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

  2. Estimated blood loss

    Time frame: Estimated blood loss will be calculated during surgery.

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

  3. The number of retrieved lymph nodes

    Time frame: The number of retrieved lymph nodes were counted after surgery

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

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.