Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481828
• Other study ID #: 2019-98
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2020

Study information

• Verified date: July 2020
• Source: Kocaeli Derince Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• gastrectomy
gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

Locations

Country	Name	City	State
Turkey	Kocaeli Derince Training and research Hospital	Kocasinan	Derince

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. Epub 2016 Jul 11. — View Citation

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. Review. — View Citation

Outcome

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