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

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07100431

3-2022-0165

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Articulating group

Experimental group

Description:

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.

Treatment:

Procedure: Articulating (experimental group)

Procedure: Control (control group)

Control group

No Intervention group

Description:

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.