Gastric CancerNCT03958032
Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer
An observational study of Gastric Cancer and Sarcopenia, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Sarcopenia, Malnutrition; Cachexia
- How many people
- 185 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2016to 10 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients undergoing surgery due to gastric cancer will be included in this study.
Who may be able to join
- Patients undergoing gastric surgery for gastric cancer
- Histologically proven gastric adenocarcinoma
- Patients over 18 years
- Patients who agreed to participate in the study
Who cannot join
- patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
- patients received palliative surgery without gastric resection (bypass procedures)
- patients required thoracotomy/thoracoscopy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University, Faculty of Medicine
Trabzon, 61080
About this study
We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer
Read the detailed 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.
- Conditions
- Gastric Cancer, Sarcopenia, Malnutrition; Cachexia, Complication
- Being tested
- No intervention
- Keywords
- sarcopenia, cancer, gastrointestinal
- Medical subject headings
- Stomach Neoplasms, Sarcopenia, Malnutrition, Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with gastric cancer | All consecutive patients undergoing surgery due to gastric cancer will be included in this study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
complications graded by Clavien-Dindo Complication Classification System
Measured: within 30 days after surgery
Secondary outcomes (9)
Length of hospital stay
time interval from the date of operation to the date of discharge
Measured: up to 90 days
Mortality
Dying after surgery
Measured: within 30 days after surgery
Readmission rate
readmission to the hospital because of the adverse events after discharge
Measured: within 30 days after surgery
Incidence of sarcopenia
Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People
Measured: one day before surgery
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.
Measured: one day before surgery
Psoas muscle mass volume
muscle mass volume of Psoas muscle with 3D reconstruction
Measured: one day before surgery
Muscle strength
evaluated by handgrip strength test (with digital dynamometer)
Measured: one day before surgery
Physical performance
evaluated by 4-meter gait speed test
Measured: one day before surgery
Major complication
grade 3 or higher complications graded by Clavien-Dindo Complication Classification System
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start3 Dec 2016
- Primary completion10 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali GUNER, Karadeniz Technical University
- Investigators
- Ali GUNER, MD, Principal investigator, Karadeniz Technical University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958032
- Sponsor's protocol ID
- sarcopenia01
- Status last verified
- Jun 2020
- First submitted
- 18 May 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova 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.
PubMed 20392703Fukuda 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.
PubMed 26407875Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe 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.
PubMed 26331988Guner 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.
PubMed 28529985
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer
- ClinicalTrials.gov ID
- NCT03958032
- Acronym / sponsor ID
- sarcopenia01
- Conditions
- Gastric Cancer, Sarcopenia, Malnutrition; Cachexia, Complication
- Keywords
- sarcopenia, cancer, gastrointestinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 3 Dec 2016 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with gastric cancer | – | Other: No interventionAll consecutive patients undergoing surgery due to gastric cancer will be included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients undergoing surgery due to gastric cancer will be included in this study.
Key inclusion criteria (4 listed)
- Patients undergoing gastric surgery for gastric cancer
- Histologically proven gastric adenocarcinoma
- Patients over 18 years
- Patients who agreed to participate in the study
Key exclusion criteria (3 listed)
- patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
- patients received palliative surgery without gastric resection (bypass procedures)
- patients required thoracotomy/thoracoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo 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. | Other | Participants with gastric cancer |
Primary outcome
Postoperative complications
Time frame: within 30 days after surgery
complications graded by Clavien-Dindo Complication Classification System
9 secondary outcomes
Length of hospital stay
Time frame: up to 90 days
Mortality
Time frame: within 30 days after surgery
Readmission rate
Time frame: within 30 days after surgery
Incidence of sarcopenia
Time frame: one day before surgery
Muscle mass volume
Time frame: one day before surgery
Psoas muscle mass volume
Time frame: one day before surgery
Muscle strength
Time frame: one day before surgery
Physical performance
Time frame: one day before surgery
Major complication
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova 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.
- Background: PubMed 26407875Fukuda 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.
- Background: PubMed 26331988Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe 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.
- Background: PubMed 28529985Guner 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.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali GUNER, MD principal investigator
Karadeniz Technical University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Sarcopenia, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958032, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.