GastrostomyPFRSSNCT04919577
Predictive Factors for Roux Stasis Syndrome
An observational study of Gastrostomy, run by Peking University Third Hospital at 1 site in China.
Trial summary
Patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 were retrospectively analyzed. The occurrence of RSS was evaluated and examined for correlations with demographic and clinicopathological data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrostomy
- What is being tested?
- X-ray
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2014to 1 May 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 at Peking University Third Hospital were retrospectively selected
Who may be able to join
- pathologically diagnosed with gastric cancer
- underwent distal gastrectomy with R-Y reconstruction
- the date of admission is between March 2014 and March 2021
- the admission place is Peking University Third Hospital.
Who cannot join
- patients with distant metastasis
- patients with palliative surgery
- death occurred within 14 days after operation
- patients with primary malignant disease in other organs besides stomach.
Trial locations and contacts
1 site in 1 country.
China1 site
General Surgery Department, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Predictive Factors for Roux Stasis Syndrome After Distal Gastrectomy With Roux-en-Y Reconstruction in Gastric Cancer Patients: A Retrospective Comparative Cohort
Patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 were retrospectively analyzed. The occurrence of RSS was evaluated and examined for correlations with demographic and clinicopathological data. "R" package was used to build a nomogram.
Read the detailed description
Patient Selection Ethical approval for this study was obtained from the medical ethics research committee of Peking University Third Hospital (IRB00006761-2019173).
Consecutive patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 at Peking University Third Hospital were retrospectively selected (the detailed screening process was shown in Figure 1).
The exclusion criteria for this study were: (1) patients with distant metastasis, (2) patients with palliative surgery, (3) death occurred within 14 days after operation, (4) patients with primary malignant disease in other organs besides stomach.
Surgical Procedure RY reconstruction was performed after standard distal gastrectomy and D2 lymph node dissection. There are several key steps involved in the RY reconstruction process. Firstly, the jejunum was dissected at 20.2cm (average value) distal to Treitz's ligament. Secondly, a side-to-side antecolic gastrojejunostomy was created using a linear stapler between the gastric stump and the distal segment of jejunum. Finally, an end-to-side or side-to-side jejunostomy was performed in output limb at about 37.2cm (average value) distal to the gastrojejunostomy (Figure 2). A cholecystectomy was performed if the patient had gallbladder-related disease.
Data collection We divided these patients into two group depending on whether RSS occurred and retrospectively analyzed the following items: gender, age, body mass index (BMI), smoking, diabetes, high carcinoembryonic antigen (CEA), hypoproteinemia, hyperlipidemia, operation approach, operation time, cholecystectomy, length of input and output loops, intestinal anastomosis approach, pathological T (pT) stage, lymph node metastasis, pathological stage, lymphovascular invasion, nerve invasion and postoperative hospital stay. According to the standard classification of BMI in China11, we divided patients into three groups, including underweight group (BMI < 18.5 kg/m2), obesity group (BMI ≥ 28.0 kg/m2) and normal group (18.5 kg/m2 ≥ BMI < 28.0 kg/m2). The cancer stage was defined according to the 8th cancer Edition Cancer Staging System presented by American Joint Committee on Cancer.
Identification of RSS We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. All three conditions must be met at the same time and should occur within 30 days after operation.
Two gastroenterologists screened each patient one by one according to the RSS definition. The third gastroenterologist discussed the inconsistent patients and jointly confirmed whether the patient had RSS.
Statistical Analysis Statistical analysis was performed using the SPSS Statistics version 26.0 software program (IBM, USA). Qualitative data were compared using the chi-square test or Fisher's exact test. Quantitative data were tested by nonparametric test with Mann-Whitney U test. We choose the variables with P < 0.1 in univariate analysis and the variables that may be related to RSS clinically to be included in multivariate analysis, using Binary logistic regression analysis (Forward Conditional). Box-Tidwell method was used to verify that the continuous independent variable and the dependent variable logit transform value to be linear relationship (p > 0.05). Linear regression was used to verify that there was no multicollinearity between each independent variable (Tolerance > 0.1, VIF < 10). Based on the logistic regression results, a nomogram for predicting RSS occurrence after radical gastrectomy for distal gastrectomy with RY anastomosis was established, and performance was quantified to determine discrimination and calibration. The model was internally validated using the 1,000 bootstrapping method to obtain relatively unbiased estimates. Nomogram was built using the "rms" package in R version 3.5.2.All tests were bilateral, and P < 0.05 was considered statistically significant.
- Conditions
- Gastrostomy
- Being tested
- X-ray
- Keywords
- Roux stasis syndrome Gastric cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rayDiagnostic test
Also called CT and Upper Gastroenterography
We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. All three conditions must be met at the same time and should occur within 30 days after operation.
| Study group | Role | What they receive |
|---|---|---|
| RSS- Group | Patients without RSS after distal gastrectomy. Receives: Diagnostic Test: X-ray | |
| RSS+ Group | Patients with RSS after distal gastrectomy. Receives: Diagnostic Test: X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roux stasis syndrome
Yes or No. We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. If all three conditions meet at the same time and occur within 30 days after operation, we choose Yes, otherwise, we choose No.
Measured: 2014.03.01 to 2021.03.01
Secondary outcomes (14)
Age
unit: years. Checking the admission record.
Measured: 2014.03.01 to 2021.03.01
body mass index (BMI)
unit: kg/m^2. Checking the admission record, get the information of weight in kilograms and height in meters, weight/height^2 get the BMI.
Measured: 2014.03.01 to 2021.03.01
smoking, diabetes
Yes or No. Checking the admission record for a history of smoking and diabetes.
Measured: 2014.03.01 to 2021.03.01
operation approach
Open or Laparoscopic. Checking the surgery record.
Measured: 2014.03.01 to 2021.03.01
operation time
unit: min. Checking the anesthesia record.
Measured: 2014.03.01 to 2021.03.01
cholecystectomy
Yes or No. Checking the surgery record to determine if cholecystectomy is complicating.
Measured: 2014.03.01 to 2021.03.01
high carcinoembryonic antigen (CEA)
Yes or No. Checking preoperative laboratory values, if CEA < 5.0 ng/ml choose No, if CEA ≥ 5.0 ng/ml, choose Yes.
Measured: 2014.03.01 to 2021.03.01
hypoproteinemia
Yes or No. Checking preoperative laboratory values, if albumin < 30.0 g/l choose Yes, if albumin ≥ 30.0 g/l , choose No.
Measured: 2014.03.01 to 2021.03.01
length of input and output loops
unit: cm. Checking the surgery record.
Measured: 2014.03.01 to 2021.03.01
intestinal anastomosis approach
End-to-side or Side-to-side. Checking the surgery record.
Measured: 2014.03.01 to 2021.03.01
pathological T (pT) stage
I or II or III. Checking the postoperative pathological report. The cancer stage was defined according to the 8th cancer Edition Cancer Staging System presented by American Joint Committee on Cancer.
Measured: 2014.03.01 to 2021.03.01
lymph node metastasis, lymphovascular invasion, nerve invasion.
Yes or NO. Checking the postoperative pathological report.
Measured: 2014.03.01 to 2021.03.01
postoperative hospital stay
unit: days. Checking the surgery and discharge record. The length of postoperative hospital stay is obtained by subtracting the date of discharge from the date of surgery.
Measured: 2014.03.01 to 2021.03.01
Gender
Male or Female. Checking the admission record.
Measured: 2014.03.01 to 2021.03.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Mar 2014
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies 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
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Fu, Peking University Third Hospital
- Investigators
- Wei Fu, MD, Principal investigator, General Surgery Department, Peking University Third HospitalXin Zhou, MD, Principal investigator, eneral Surgery Department, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919577
- Sponsor's protocol ID
- PekingUTH M2019173
- Acronym
- PFRSS
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may upload our raw data to Mendeley Data after accepted.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Roux Stasis Syndrome After Distal Gastrectomy With Roux-en-Y Reconstruction in Gastric Cancer Patients: A Retrospective Comparative Cohort
- ClinicalTrials.gov ID
- NCT04919577
- Acronym / sponsor ID
- PFRSS / PekingUTH M2019173
- Conditions
- Gastrostomy
- Keywords
- Roux stasis syndrome Gastric cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 9 Jun 2021 (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.
Patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 were retrospectively analyzed. The occurrence of RSS was evaluated and examined for correlations with demographic and clinicopathological data. "R" package was used to build a nomogram.
Detailed description
Patient Selection Ethical approval for this study was obtained from the medical ethics research committee of Peking University Third Hospital (IRB00006761-2019173).
Consecutive patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 at Peking University Third Hospital were retrospectively selected (the detailed screening process was shown in Figure 1).
The exclusion criteria for this study were: (1) patients with distant metastasis, (2) patients with palliative surgery, (3) death occurred within 14 days after operation, (4) patients with primary malignant disease in other organs besides stomach.
Surgical Procedure RY reconstruction was performed after standard distal gastrectomy and D2 lymph node dissection. There are several key steps involved in the RY reconstruction process. Firstly, the jejunum was dissected at 20.2cm (average value) distal to Treitz's ligament. Secondly, a side-to-side antecolic gastrojejunostomy was created using a linear stapler between the gastric stump and the distal segment of jejunum. Finally, an end-to-side or side-to-side jejunostomy was performed in output limb at about 37.2cm (average value) distal to the gastrojejunostomy (Figure 2). A cholecystectomy was performed if the patient had gallbladder-related disease.
Data collection We divided these patients into two group depending on whether RSS occurred and retrospectively analyzed the following items: gender, age, body mass index (BMI), smoking, diabetes, high carcinoembryonic antigen (CEA), hypoproteinemia, hyperlipidemia, operation approach, operation time, cholecystectomy, length of input and output loops, intestinal anastomosis approach, pathological T (pT) stage, lymph node metastasis, pathological stage, lymphovascular invasion, nerve invasion and postoperative hospital stay. According to the standard classification of BMI in China11, we divided patients into three groups, including underweight group (BMI < 18.5 kg/m2), obesity group (BMI ≥ 28.0 kg/m2) and normal group (18.5 kg/m2 ≥ BMI < 28.0 kg/m2). The cancer stage was defined according to the 8th cancer Edition Cancer Staging System presented by American Joint Committee on Cancer.
Identification of RSS We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. All three conditions must be met at the same time and should occur within 30 days after operation.
Two gastroenterologists screened each patient one by one according to the RSS definition. The third gastroenterologist discussed the inconsistent patients and jointly confirmed whether the patient had RSS.
Statistical Analysis Statistical analysis was performed using the SPSS Statistics version 26.0 software program (IBM, USA). Qualitative data were compared using the chi-square test or Fisher's exact test. Quantitative data were tested by nonparametric test with Mann-Whitney U test. We choose the variables with P < 0.1 in univariate analysis and the variables that may be related to RSS clinically to be included in multivariate analysis, using Binary logistic regression analysis (Forward Conditional). Box-Tidwell method was used to verify that the continuous independent variable and the dependent variable logit transform value to be linear relationship (p > 0.05). Linear regression was used to verify that there was no multicollinearity between each independent variable (Tolerance > 0.1, VIF < 10). Based on the logistic regression results, a nomogram for predicting RSS occurrence after radical gastrectomy for distal gastrectomy with RY anastomosis was established, and performance was quantified to determine discrimination and calibration. The model was internally validated using the 1,000 bootstrapping method to obtain relatively unbiased estimates. Nomogram was built using the "rms" package in R version 3.5.2.All tests were bilateral, and P < 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSS- Group | – | Diagnostic Test: X-rayPatients without RSS after distal gastrectomy. |
| RSS+ Group | – | Diagnostic Test: X-rayPatients with RSS after distal gastrectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 at Peking University Third Hospital were retrospectively selected
Key inclusion criteria (4 listed)
- pathologically diagnosed with gastric cancer
- underwent distal gastrectomy with R-Y reconstruction
- the date of admission is between March 2014 and March 2021
- the admission place is Peking University Third Hospital.
Key exclusion criteria (4 listed)
- patients with distant metastasis
- patients with palliative surgery
- death occurred within 14 days after operation
- patients with primary malignant disease in other organs besides stomach.
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 |
|---|---|---|
| X-rayAlso: CT and Upper GastroenterographyWe defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. All three conditions must be met at the same time and should occur within 30 days after operation. | Diagnostic test | RSS+ Group, RSS- Group |
Primary outcome
Roux stasis syndrome
Time frame: 2014.03.01 to 2021.03.01
Yes or No. We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. If all three conditions meet at the same time and occur within 30 days after operation, we choose Yes, otherwise, we choose No.
14 secondary outcomes
Age
Time frame: 2014.03.01 to 2021.03.01
body mass index (BMI)
Time frame: 2014.03.01 to 2021.03.01
smoking, diabetes
Time frame: 2014.03.01 to 2021.03.01
operation approach
Time frame: 2014.03.01 to 2021.03.01
operation time
Time frame: 2014.03.01 to 2021.03.01
cholecystectomy
Time frame: 2014.03.01 to 2021.03.01
high carcinoembryonic antigen (CEA)
Time frame: 2014.03.01 to 2021.03.01
hypoproteinemia
Time frame: 2014.03.01 to 2021.03.01
length of input and output loops
Time frame: 2014.03.01 to 2021.03.01
intestinal anastomosis approach
Time frame: 2014.03.01 to 2021.03.01
pathological T (pT) stage
Time frame: 2014.03.01 to 2021.03.01
lymph node metastasis, lymphovascular invasion, nerve invasion.
Time frame: 2014.03.01 to 2021.03.01
postoperative hospital stay
Time frame: 2014.03.01 to 2021.03.01
Gender
Time frame: 2014.03.01 to 2021.03.01
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 9 Jun 2021.
- Individual participant dataSharing planned: Undecided. We may upload our raw data to Mendeley Data after accepted.
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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.
Wei Fu, MD principal investigator
General Surgery Department, Peking University Third Hospital
Xin Zhou, MD principal investigator
eneral Surgery Department, Peking University Third Hospital
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 Gastrostomy, run by Peking University Third Hospital 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 4 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 9 Jun 2021. 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?
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?
Roux stasis syndrome (time frame: 2014.03.01 to 2021.03.01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2021.