Clinical trial NCT03393182: Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).
Official title: A Multicenter Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopy-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric cancer_KLASS 07 (CKLASS01)(Korea-China Collaborated Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Gastric Cancer
Surgery
Surgical Complication
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Medical College of Fudan University
First posted: 2018-01-08
Enrollment: 443
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, multi-center trial that comparing surgical complications and Quality of Life between "Totally laparoscopic distal gastrectomy" and "Laparoscopy-assisted distal gastrectomy" in Korea.
Primary purpose: TREATMENT

Brief summary: The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.

Detailed description: The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery.

Early postoperative morbidity is classified as follows:

(1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc.

The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.

Eligibility criteria: Inclusion Criteria:

* Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
* Age between 20 and 80 years old
* Eastern Cooperative Oncology Group performance statu of 0 or 1
* Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system10 (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
* Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).)
* Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation

Exclusion Criteria:

* Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past
* Patients with intraabdominal adhesion due to previous intraperitoneal surgery
* Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy
* Patients who requires combined organ resection due to aggression of gastric cancer or other diseases
* Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions).
* Vulnerable people who can't communicate or are pregnant (or planning to be pregnant)
* Patients who are currently participating or participated in other clinical trials in the last six months.

Primary outcomes:
measure: Postoperative 30-day morbidity rate
timeFrame: Postoperative 30-day
Secondary outcomes:
measure: QOL measurement : EORTC QLQ-C30/STO22
timeFrame: screening(pre op) / Postoperative 30-day,3-month,6-month,12-month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
citation: Lee CM, Park JH, In Choi C, Lee HH, Min JS, Jee YS, Jeong O, Chae H, Choi SI, Huang H, Park S. A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol). BMC Cancer. 2019 Mar 7;19(1):206. doi: 10.1186/s12885-019-5396-8.