Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Multicenter Prospective Randomized Controlled Trial of Comparing Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy for Upper Third Early Gastric Cancer (KLASS-05)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892643
• Other study ID #: B-1609-361-001
• Status: Completed
• Phase: N/A
• Start date: October 27, 2016
• Est. completion date: September 17, 2020

Study information

• Verified date: January 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

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 Bundang Hospital Medical Research Collaborating Center.

Each group 69 patients, total 138 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: Completed
• Enrollment: 138
• Est. completion date: September 17, 2020
• Est. primary completion date: September 17, 2018
• 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 adenocarcinoma through endoscopic biopsy Aged 20-80 years old Written signed informed consent No other malignancies Proximal gastric cancer met by following conditions ; Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to mucosa or submucosa (cT1) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis.

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

Exclusion Criteria:

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

History of anemia Patients who need total gastrectomy History of pre-operative chemotherapy or radiation therapy for gastric cancer Patients who need combined resection (except cholecystectomy) Presence of other malignancies Prior treatment against systemic inflammatory disease Previous gastric surgery Vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic proximal gastrectomy
Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
• Laparoscopic total gastrectomy
Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Keimyung University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Eulji University Hospital, Deajon	Daejeon
Korea, Republic of	Chonnam National University Hospital	Hwasun
Korea, Republic of	National Cancer Center	Ilsan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Hemoglobin	from blood sample	up to 2 years postoperatively
Primary	Vitamin B12 cumulative supplement quantity	from blood sample	up to 2 years postoperatively
Secondary	Operative morbidity	Complications occuring after operation	30 days for early morbidity
Secondary	Operative mortality	Mortality after operation	mortality for 90 days
Secondary	QOL measurement	EORTC C30/STO22	6 month, 1 year, 2 year, postoperatively
Secondary	Reflux esophagitis	assessed by Visick score and endoscopic grading according to LA classification	check at every 12 months up to 2 years postoperatively
Secondary	Relapse-free survival	Relapse-free survival	2 years postoperatively
Secondary	Overall survival	Overall survival	2 years postoperatively