Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).

Korea University

Status: Completed

Conditions: Gastric Cancer; Quality of Life; Surgery; Surgical Complication

Treatments: Procedure: TLDG arm; Procedure: LADG arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03393182

KLASS07(CKLASS01)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 443 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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443 participants in 2 patient groups

TLDG arm

Experimental group

Description:

TLDG arm(Totally laparoscopic distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.

Treatment:

Procedure: TLDG arm

LADG arm

Experimental group

Description:

LADG arm(Laparoscopy-assisted distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy

Treatment:

Procedure: LADG arm