NCT03393182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

3.5 years

First QC Date

January 2, 2018

Last Update Submit

April 12, 2022

Conditions

Quality of LifeGastric CancerSurgerySurgical Complication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • QOL measurement : EORTC QLQ-C30/STO22

    screening(pre op) / Postoperative 30-day,3-month,6-month,12-month

Study Arms (2)

TLDG arm

EXPERIMENTAL

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

Procedure: TLDG arm

LADG arm

EXPERIMENTAL

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

Procedure: LADG arm

Interventions

TLDG armPROCEDURE

After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)

TLDG arm
LADG armPROCEDURE

After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)

LADG arm

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Related Publications (4)

  • Zhang Y, Li Z, Tian Y, Yu J, Wang J, Lee C, Wang K, He X, Qiao Q, Ji G, Xu Z, Yang L, Xu H, Du X, Su X, Xing J, Niu Z, Zhu L, Yan S, Li Y, Wang J, Li Z, Zhao Y, You J, Jing C, Fan L, Du Y, Zhao G, Song W, Xuan Y, Zang M, Chen J, Park S, Huang H; China-Korea Laparoscopic Gastrointestinal Surgery Study (CKLASS) Cooperative Group. Morbidity and quality of life of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer: a multi-center prospective randomized controlled trial (CKLASS01). Gastric Cancer. 2025 Jan;28(1):131-144. doi: 10.1007/s10120-024-01561-y. Epub 2024 Nov 5.

    PMID: 39499377DERIVED

  • Lee HH, Lee CM, Lee MS, Jeong IH, Son MW, Kim CH, Yoo MW, Oh SJ, Son YG, Choi SI, Jung MR, Seo SH, Park SH, Hwang SH, Min JS, Park S. Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial). J Gastric Cancer. 2024 Jul;24(3):257-266. doi: 10.5230/jgc.2024.24.e22.

    PMID: 38960885DERIVED

  • Park SH, Lee CM, Hur H, Min JS, Ryu SW, Son YG, Chae HD, Jeong O, Jung MR, Choi CI, Song KY, Lee HH, Kim HG, Jee YS, Hwang SH, Lee MS, Kim KH, Seo SH, Jeong IH, Son MW, Kim CH, Yoo MW, Oh SJ, Kim JG, Hwang SH, Choi SI, Yang KS, Huang H, Park S. Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07: a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4810-4820. doi: 10.1097/JS9.0000000000001543.

    PMID: 38716987DERIVED

  • 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.

    PMID: 30845995DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 8, 2018

Study Start

March 1, 2018

Primary Completion

August 18, 2021

Study Completion

February 18, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

KR(1)