Clinical trial NCT05494086: Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer
Official title: Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: DPLDG group :Reduced Port Laparoscopic Distal Gastrectomy LDG group: Laparoscopic Distal Gastrectomy
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Early operative morbidity
timeFrame: Within 30 days following surgery
Secondary outcomes:
measure: 5 year overall survival rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Guoxin Li, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Tian Lin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: