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

NCT ID: NCT07100431

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Articulating group

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.

Group Type: EXPERIMENTAL

Articulating (experimental group)

Intervention Type: 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.

Control (control group)

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Articulating (experimental group)

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.

Intervention Type: PROCEDURE

Control (control group)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery

2. Patients scheduled for laparoscopic radical gastrectomy

3. Patients aged more than 20

4. Patients with an ECOG 0 or 1

Exclusion Criteria

1. Patients with a history of gastrectomy

2. Patients with a history of pancreatitis or pancreatic surgery

3. Patients with a history of abdominal surgery who are expected to have severe intra-abdominal adhesions

4. Patients scheduled for total gastrectomy with D2 lymph node dissection

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Gyu Kwon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GangnamSeverance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2022-0165

Identifier Type: -

Identifier Source: org_study_id