Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid TherapyNCT07583927
Anemia on Sublingual Microcirculation in GDFT
An observational study of Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy and Macro-microcirculation Uncoupling, run by Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effects of anemia on sublingual microcirculation in patients undergoing goal-directed fluid therapy (GDFT) during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy, Macro-microcirculation Uncoupling
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult patients (age ≥18 years) scheduled for elective open radical gastrectomy for gastric cancer at Fudan University Shanghai Cancer Center. Patients are assigned to two groups based on their preoperative hemoglobin level: anemic group (Hb ≤10 g/dL) and non-anemic group (Hb >10 g/dL). All patients undergo standardized goal-directed fluid therapy during surgery and receive general anesthesia with endotracheal intubation.
Who may be able to join
- Scheduled for elective open radical gastrectomy
- Age ≥ 18 years
- ASA physical status I-III
- Undergoing general anesthesia with endotracheal intubation
Who cannot join
- Untreated ischemic heart disease or severe cardiovascular disease
- Acute or chronic respiratory failure, severe asthma, pulmonary bullae, pneumothorax, emphysema, bronchopleural fistula
- Oral or tongue disorders
- Scheduled for laparoscopic surgery
- Inability to position or observe the patient's head during surgery
- Refusal to participate after entering the operating room
- Intraoperative life-threatening events
- Hemodynamic instability during surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Cancer Center, Fudan University
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Effects of Anemia on Sublingual Microcirculation in Patients Undergoing Goal-Directed Fluid Therapy: A Prospective Observational Study
The goal of this observational study is to learn about the effects of anemia on sublingual microcirculation in patients undergoing goal-directed fluid therapy (GDFT) during surgery. The main question it aims to answer is:
Does anemia, under the condition of goal-directed fluid therapy, lead to significant changes in sublingual microcirculatory parameters (such as microvascular density and perfusion)?
Participants will include 54 patients scheduled for elective open radical gastrectomy (27 anemic vs. 27 non-anemic). Sublingual microcirculation will be assessed using a side-stream dark field imaging device at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). All patients will receive intraoperative GDFT guided by pulse pressure variation (PPV) and cardiac output (CO) via the Vigileo-FloTrac system.
- Conditions
- Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy, Macro-microcirculation Uncoupling
- Being tested
- No intervention
- Keywords
- Anemia, Sublingual Microcirculation, Goal-Directed Fluid Therapy (GDFT), Macro-microcirculation Uncoupling, Radical Gastrectomy
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. Participants are assigned to groups based on their preoperative anemia status (hemoglobin ≤10 g/dL vs. >10 g/dL). No experimental intervention is administered. All patients receive standardized clinical care including goal-directed fluid therapy and open radical gastrectomy as per routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Anemic Group | Patients with preoperative hemoglobin (Hb) ≤ 10 g/dL scheduled for elective open radical gastrectomy. All patients receive standardized goal-directed fluid therapy (GDFT) and undergo sublingual microcirculation assessment at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). Receives: Other: No intervention | |
| Non-anemic Group | Patients with preoperative hemoglobin (Hb) > 10 g/dL scheduled for elective open radical gastrectomy. All patients receive standardized goal-directed fluid therapy (GDFT) and undergo sublingual microcirculation assessment at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Vessel Density (TVD)
Total vessel density is defined as total vessel length (mm) per unit area (mm²), calculated as: TVD = total vessel length / area of the field of view. Sublingual microcirculation videos are acquired using a side-stream dark field imaging device (MicroScan, MicroVision Medical). Vessels with diameter <20 μm are analyzed using MicroSee image management software. Three videos are recorded at each measurement time point, and the average value is reported.
Measured: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Perfused Vessel Density (PVD)
Perfused vessel density is defined as perfused vessel length (mm) per unit area (mm²), calculated as: PVD = perfused vessel length / area of the field of view. Perfusion is defined as continuous or sluggish flow (score ≥2 on the microvascular flow scale). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter <20 μm are analyzed using MicroSee software. Three videos are recorded at this time point, and the average PVD value is reported.
Measured: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Proportion of Perfused Vessels (PPV)
Proportion of perfused vessels is defined as the percentage of total vessel length that is perfused, calculated as: PPV (%) = (perfused vessel length / total vessel length) × 100%. Perfusion is defined as continuous or sluggish flow (score ≥2 on the microvascular flow scale). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter <20 μm are analyzed using MicroSee software. Three videos are recorded at this time point, and the average PPV is reported.
Measured: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Microvascular Flow Index (MFI)
Microvascular flow index is a semi-quantitative measure of microvascular flow velocity. The field of view is divided into four quadrants. Flow in each quadrant is scored as: 0 = no flow, 1 = intermittent flow, 2 = sluggish flow, 3 = continuous flow. MFI is calculated as the average score across the four quadrants (range 0-3, with higher scores indicating better microvascular flow). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter <20 μm are analyzed. Three videos are recorded at this time point, and the average MFI is reported.
Measured: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid TherapyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583927
- Sponsor's protocol ID
- 2604-Exp428
- Status last verified
- Apr 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Wei S, He Z, Zhang J. Alteration of sublingual microcirculation in anemic patients during gastric cancer surgery under goal-directed fluid therapy: a prospective cohort study. J Clin Monit Comput. 2026 Oct 15. doi: 10.1007/s10877-026-01511-2. Online ahead of print.
PubMed 42879041
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anemia on Sublingual Microcirculation in Patients Undergoing Goal-Directed Fluid Therapy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07583927
- Acronym / sponsor ID
- 2604-Exp428
- Conditions
- Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy, Macro-microcirculation Uncoupling
- Keywords
- Anemia, Sublingual Microcirculation, Goal-Directed Fluid Therapy (GDFT), Macro-microcirculation Uncoupling, Radical Gastrectomy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 May 2026 (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.
The goal of this observational study is to learn about the effects of anemia on sublingual microcirculation in patients undergoing goal-directed fluid therapy (GDFT) during surgery. The main question it aims to answer is:
Does anemia, under the condition of goal-directed fluid therapy, lead to significant changes in sublingual microcirculatory parameters (such as microvascular density and perfusion)?
Participants will include 54 patients scheduled for elective open radical gastrectomy (27 anemic vs. 27 non-anemic). Sublingual microcirculation will be assessed using a side-stream dark field imaging device at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). All patients will receive intraoperative GDFT guided by pulse pressure variation (PPV) and cardiac output (CO) via the Vigileo-FloTrac system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemic Group | – | Other: No interventionPatients with preoperative hemoglobin (Hb) ≤ 10 g/dL scheduled for elective open radical gastrectomy. All patients receive standardized goal-directed fluid therapy (GDFT) and undergo sublingual microcirculation assessment at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). |
| Non-anemic Group | – | Other: No interventionPatients with preoperative hemoglobin (Hb) > 10 g/dL scheduled for elective open radical gastrectomy. All patients receive standardized goal-directed fluid therapy (GDFT) and undergo sublingual microcirculation assessment at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (age ≥18 years) scheduled for elective open radical gastrectomy for gastric cancer at Fudan University Shanghai Cancer Center. Patients are assigned to two groups based on their preoperative hemoglobin level: anemic group (Hb ≤10 g/dL) and non-anemic group (Hb >10 g/dL). All patients undergo standardized goal-directed fluid therapy during surgery and receive general anesthesia with endotracheal intubation.
Key inclusion criteria (4 listed)
- Scheduled for elective open radical gastrectomy
- Age ≥ 18 years
- ASA physical status I-III
- Undergoing general anesthesia with endotracheal intubation
Key exclusion criteria (8 listed)
- Untreated ischemic heart disease or severe cardiovascular disease
- Acute or chronic respiratory failure, severe asthma, pulmonary bullae, pneumothorax, emphysema, bronchopleural fistula
- Oral or tongue disorders
- Scheduled for laparoscopic surgery
- Inability to position or observe the patient's head during surgery
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 interventionThis is an observational study. Participants are assigned to groups based on their preoperative anemia status (hemoglobin ≤10 g/dL vs. >10 g/dL). No experimental intervention is administered. All patients receive standardized clinical care including goal-directed fluid therapy and open radical gastrectomy as per routine practice. | Other | Anemic Group, Non-anemic Group |
Primary outcome
Total Vessel Density (TVD)
Time frame: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Total vessel density is defined as total vessel length (mm) per unit area (mm²), calculated as: TVD = total vessel length / area of the field of view. Sublingual microcirculation videos are acquired using a side-stream dark field imaging device (MicroScan, MicroVision Medical). Vessels with diameter <20 μm are analyzed using MicroSee image management software. Three videos are recorded at each measurement time point, and the average value is reported.
Perfused Vessel Density (PVD)
Time frame: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Perfused vessel density is defined as perfused vessel length (mm) per unit area (mm²), calculated as: PVD = perfused vessel length / area of the field of view. Perfusion is defined as continuous or sluggish flow (score ≥2 on the microvascular flow scale). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter <20 μm are analyzed using MicroSee software. Three videos are recorded at this time point, and the average PVD value is reported.
Proportion of Perfused Vessels (PPV)
Time frame: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Proportion of perfused vessels is defined as the percentage of total vessel length that is perfused, calculated as: PPV (%) = (perfused vessel length / total vessel length) × 100%. Perfusion is defined as continuous or sluggish flow (score ≥2 on the microvascular flow scale). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter <20 μm are analyzed using MicroSee software. Three videos are recorded at this time point, and the average PPV is reported.
Microvascular Flow Index (MFI)
Time frame: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).
Microvascular flow index is a semi-quantitative measure of microvascular flow velocity. The field of view is divided into four quadrants. Flow in each quadrant is scored as: 0 = no flow, 1 = intermittent flow, 2 = sluggish flow, 3 = continuous flow. MFI is calculated as the average score across the four quadrants (range 0-3, with higher scores indicating better microvascular flow). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter <20 μm are analyzed. Three videos are recorded at this time point, and the average MFI is reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 42879041Li Y, Wei S, He Z, Zhang J. Alteration of sublingual microcirculation in anemic patients during gastric cancer surgery under goal-directed fluid therapy: a prospective cohort study. J Clin Monit Comput. 2026 Oct 15. doi: 10.1007/s10877-026-01511-2. Online ahead of print.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy and Macro-microcirculation Uncoupling, run by Fudan University at 1 site in China.
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 8 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: enrolling by invitation, as of the sponsor's last update on 13 May 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total Vessel Density (TVD) (time frame: before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).). The study lists 4 primary outcomes in all. 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 NCT07583927, which also lists 1 linked publication.
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 13 May 2026.