Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center

In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: gastrectomy

Detailed Description

The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Derince
    • Kocasinan, Derince, Turkey, 41900
      • Kocaeli Derince Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer.

Description

Inclusion Criteria:

• Gastric cancer(adenocarcinoma) proven biopsy
• Operated by same surgical team
• Presence of distant metastasis

Exclusion Criteria:

• Patients who underwent palliative resection
• operated by a different surgical team
• ASA score: 4

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
open gastrectomy; The first group (Group 1; n: 30) consisted of patients who underwent open surgery	Procedure: gastrectomy; gastric resection with lymph node dissection(D1+,D2) for stomach cancer.
laparoscopic gastrectomy; The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy	Procedure: gastrectomy; gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	year	2014-2019
Body mass index	kg/m2	2014- 2019
Previous abdominal surgery status	yes or no	2014-2019
Comorbidity status	present or absent	2014 -2019
Neoadjuvant therapy status	present or absent	2014-2019
American Society of Anesthesiologists (ASA) score	1,2,3,4	2014-2019
Gender	male or female	2014-2019
Surgical technique	open or laparoscopic	2014-2019
Tumor localization	proximal, middle, lower	2014 - 2019
Gastrectomy type	total, subtotal	2014 - 2019
Lymph node dissection type	D1+, D2	2014 - 2019
Operation time	minute	2014 - 2019
Blood loss	ml	2014 - 2019
Complication (Clavien-Dindo Classification)	1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)	2014 - 2019
30-day mortality	present or absent	2014 - 2019
Number of harvested lymph node	number	2014 - 2019
Resection margin status	positive or negative	2014 - 2019
Tumor stage (American Joint Committee on Cancer 8th Edition)	0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)	2014 - 2019

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital

Publications and helpful links

General Publications

• Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.
• van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.
• Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2019-98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No