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Trial Title:
Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer
NCT ID:
NCT05494086
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
DPLDG group :Reduced Port Laparoscopic Distal Gastrectomy LDG group: Laparoscopic Distal
Gastrectomy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
DPLDG
Description:
Dual-port laparoscopic distal gastrectomy
Arm group label:
DPLDG arm
Intervention type:
Procedure
Intervention name:
LDG
Description:
Laparoscopic distal gastrectomy
Arm group label:
LDG arm
Summary:
Dual-port laparoscopic gastrectomy (DPLG) has been widely performed in recent years for
treating gastric cancers. The present study explore the safety and effect of dual-port
laparoscopic distal gastrectomy (DPLDG).
Detailed description:
As a novel minimally invasive technique,laparoscopic surgery has presently become widely
accepted as an alternative treatment for malignant diseases. In the treatment of gastric
cancers, it has been reported to be an optionalprocedure with the advantages of less
invasiveness,less blood loss, faster postoperative recovery and shorter hospital stay,
when compared to open surgery. In general, four or five trocars are required in
conventional laparoscopic distal gastrectomy (CLDG), and each port results in abdominal
injury, which may lead to port site complications, such as wound infection, dehiscence
and small bowel herniation. Hence, it remains challenging to determine whether surgical
wounds could be minimized during laparoscopic gastric surgery. The development of
reduced-port laparoscopic techniques has been largely due to the appearance of
multi-channel ports. A conventional trocar port can only be used for inserting a single
instrument. With the advancement of laparoscopic devices, a variety of multi-channel
ports have been introduced and used in laparoscopic surgeries. At present, multi-channel
ports that have been reported include Uni-X devices (Pnavel Systems, Brooklyn, NY, USA),
TriPort devices (Advanced Surgical Concepts,Wicklow, Ireland), SILS devices (Covidien,
Norwalk, CT, USA), OctoPort devices (DalimSurgNet, Seoul, Korea) and self-made
multichannel devices from medical centers globally. The number of ports located on these
multichannel devices varies from two to four. Twoport and three-port devices are more
commonly used at present in laparoscopic gastric cancer surgery. In recent years, the use
of reduced-port laparoscopic gastrectomy has rapidly increased. Several studies have
suggested that, in contrast to conventional laparoscopic gastrectomy (CLG), the
reduced-port method has some apparent postoperative benefits in the treatment of gastric
cancers, such as shorter hospital stay, less pain, less blood loss and better cosmetic
results. Among these studies, most have been about distal gastrectomy. Hence, the
application of this technique in total gastrectomy is at present relatively less. As a
type of reduced-port technique, Kawamura et al. first used this technique in 2011 to
treat early distal gastric cancers, and suggested that dual-port laparoscopic distal
gastrectomy (DPLDG) is superior to conventional approaches from the cosmetic standpoint,
and has the potential to become a technically acceptable procedure. However, due to the
more limited operating space when compared to CLDG, it has been generally considered that
DPLDG is more difficult to perform than CLDG. The difficulty of DPLDG is mainly due to
insufficient intraoperative traction and exposure, which makes the principle of
triangulation and counteraction in DPLDG less good when compared to those in CLDG. In
addition, since merely one additional trocar is located at one side of the abdominal
wall, it is difficult for the surgeon to change position with the assistant, when
necessary. The application of DPLDG to distal gastric cancer remains controversial, and
critical comments have been made regarding it.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. patients within 18--75 years old;
2. patients with a preoperative pathological diagnosis of gastric adenocarcinoma;
3. patients with a clinical tumor stage of T1N1,T2N0 according to the preoperative
examinations (gastroscopy, ultrasound gastroscopy and computed tomography);
4. patients with a plan to undergo laparoscopic distal gastrectomy and obtain R0
surgical results;
5. patients without severe heart, liver, lung, or kidney dysfunction;
6. patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of
0-1; and (7) patients with American Society of Anesthesiologists (ASA) I-II.
Exclusion Criteria:
1. patients with a history of upperabdominal surgery;
2. patients who presentedas an emergency case;
3. patients with other histories of malignant diseases within 5 years;
4. patients with prior neoadjuvant chemotherapy or radiation therapy; and (5)patients
who need simultaneous surgical treatment for other malignant diseases.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Tian Lin, Prof.
Phone:
8613560035029
Phone ext:
86
Email:
lintian108@163.com
Contact backup:
Last name:
Xinhua Chen
Phone:
8615626452302
Investigator:
Last name:
Tian Lin, Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Guoxin Li, Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Xinhua Chen
Email:
Principal Investigator
Start date:
August 1, 2022
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494086