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

Quality of Life Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393182
• Other study ID #: KLASS07(CKLASS01)
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: February 18, 2022

Study information

• Verified date: April 2022
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: February 18, 2022
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Quality of Life
• Stomach Neoplasms
• Surgery
• Surgical Complication

Intervention

Procedure:
• TLDG arm
After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
• LADG arm
After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Shanghai Medical College of Fudan University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative 30-day morbidity rate	Check the morbidity rate; :Wound, seroma, hematoma, wound infection, wound dehiscence, wound evisceration, Fluid collection/Abscess, Intraabdominal bleeding, Intraluminal bleeding, Postoperative ileus, Anastomosis stenosis, Anastomosis leakage, Pancreatitis or pancreatic fistula, Complication(Pulmonary, Urinary, Renal, Hepatic, Cardiac, Endocrine) etc.	Postoperative 30-day
Secondary	QOL measurement : EORTC QLQ-C30/STO22	EORTC QLQ-C30/STO22	screening(pre op) / Postoperative 30-day,3-month,6-month,12-month