Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

Gastric Cancer Clinical Trial

— KLASS-04  

Official title:

Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02595086
• Other study ID #: KLASS-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2023

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer

Description:

Participating Surgeons

Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.

Patients Registration

It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center.

Each group 128 patients, total 256 subjects will be enrolled.

Randomization

The registration randomization should be done with 1:1 ratio for each researcher.

Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.

Procedure

Operations are performed according to the allocated group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients are included in the trial if they meet all of the following criteria:

• histologically proven primary gastric adenocarcinoma

• aged 20-80 years old

• performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale

• performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score

• clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)

• location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)

• written signed informed consent

Exclusion Criteria:

Patients are excluded if they meet any of the following criteria:

• pyloric deformity because peptic ulcer disease

• previous gastric surgery (e.g. gastro-jejunostomy, primary closure)

• synchronous lesion of early gastric cancer or adenoma in antrum

• prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies

• patients who need combined resection (eg. cholecystectomy)

• vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)

• participated in another clinical trial within the last six months or currently involved patients

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic PPG
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
• Laparoscopic DG
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu	Jung-gu
Korea, Republic of	National Cacner Center	Goyang-si
Korea, Republic of	Department of Surgery, Seoul National University BUNDANG Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dumping syndrome, assessed by Sigstad score (=7)		1 years postoperatively
Secondary	Relapse-free survival		3 years postoperatively
Secondary	Overall survival		3 years postoperatively
Secondary	Operative morbidity		30 days for early morbidity
Secondary	Operative mortality		mortality for 90 days
Secondary	Body weight change		check at every visit up to 3 years postoperatively
Secondary	Fat volume change on abdominal CT scan		check at every 1 year up to 3 years postoperatively
Secondary	Change of Hemoglobin		check at every visit up to 3 years postoperatively
Secondary	Change of Protein		check at every visit up to 3 years postoperatively
Secondary	Change of Albumin		check at every visit up to 3 years postoperatively
Secondary	QOL measurement (EORTC C30/STO22) (composite)		6 month, 1 year, 2 year, 3 year postoperatively
Secondary	Incidence of gallbladder stone		check at every 6 months up to 3 years postoperatively
Secondary	Gross and microscopic changes measured by gastroscopy (composite)		1 year, 2 year, 3 year postoperatively