Comparison of Safety and Clinical Effects of Straight and Articulated Instruments (ArtiSential) in Laparoscopic Gastrectomy for Gastric Cancer Patients, a Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gangnam Severance Hospital
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- The reduction in operative time achieved by using an articulating instrument for dissection of suprapancreatic lymph nodes during laparoscopic gastrectomy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Patients were randomly assigned in a 1:1 ratio to two groups; the control group or the experimental (Articulating) group.
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Articulating (experimental group) (Procedure)
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.
Intervention: Control (control group) (Procedure)
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.
Outcomes
Primary Outcomes
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
- The number of retrieved lymph nodes(The number of retrieved lymph nodes were counted after surgery)
- 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.)
Investigators
In Gyu Kwon
Assistant Professor
Gangnam Severance Hospital