Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958032
• Other study ID #: sarcopenia01
• Status: Completed
• Start date: December 3, 2016
• Est. completion date: June 10, 2020

Study information

• Verified date: June 2020
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

Description:

Among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. The only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. Therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. For the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. Previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. The majority of studies regarding gastric cancer was published from Eastern countries owing to their high incidence. There are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. In the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: June 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing gastric surgery for gastric cancer

2. Histologically proven gastric adenocarcinoma

3. Patients over 18 years

4. Patients who agreed to participate in the study

Exclusion Criteria:

1. patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)

2. patients received palliative surgery without gastric resection (bypass procedures)

3. patients required thoracotomy/thoracoscopy

Related Conditions & MeSH terms

• Cachexia
• Complication
• Gastric Cancer
• Malnutrition
• Malnutrition; Cachexia
• Sarcopenia
• Stomach Neoplasms

Intervention

Other:
• No intervention
No intervention is planned for the participants for the treatment of gastric cancer. Treatment decision will be in line with clinical practice guidelines. Surgical team will be blind to the participant's sarcopenia status.

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University, Faculty of Medicine	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. — View Citation

Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Nagatsuma Y, Nakayama T, Tanikawa S, Maeda S, Uemura M, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Sarcopenia is associated with severe postoperative complications in elderly gastric cancer patients undergoing gastrectomy. Gastric Cancer. 2016 Jul;19(3):986-93. doi: 10.1007/s10120-015-0546-4. Epub 2015 Sep 25. — View Citation

Guner A. Recent trends of gastric cancer treatment in Turkey. Transl Gastroenterol Hepatol. 2017 Apr 26;2:31. doi: 10.21037/tgh.2017.04.01. eCollection 2017. Review. — View Citation

Tegels JJ, van Vugt JL, Reisinger KW, Hulsewé KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	complications graded by Clavien-Dindo Complication Classification System	within 30 days after surgery
Secondary	Length of hospital stay	time interval from the date of operation to the date of discharge	up to 90 days
Secondary	Mortality	Dying after surgery	within 30 days after surgery
Secondary	Readmission rate	readmission to the hospital because of the adverse events after discharge	within 30 days after surgery
Secondary	Incidence of sarcopenia	Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People	one day before surgery
Secondary	Muscle mass volume	muscle mass volume of a cross-sectional computerized- tomography image of the L3, corrected for patient height resulting in L3 muscle index.	one day before surgery
Secondary	Psoas muscle mass volume	muscle mass volume of Psoas muscle with 3D reconstruction	one day before surgery
Secondary	Muscle strength	evaluated by handgrip strength test (with digital dynamometer)	one day before surgery
Secondary	Physical performance	evaluated by 4-meter gait speed test	one day before surgery
Secondary	Major complication	grade 3 or higher complications graded by Clavien-Dindo Complication Classification System	within 30 days after surgery