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AzTrials

GastrostomyPFRSSNCT04919577

Predictive Factors for Roux Stasis Syndrome

An observational study of Gastrostomy, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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 groups in NCT04919577
Study groupRoleWhat they receive
RSS- GroupPatients without RSS after distal gastrectomy.
Receives: Diagnostic Test: X-ray
RSS+ GroupPatients 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.

  1. 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)
  1. Age

    unit: years. Checking the admission record.

    Measured: 2014.03.01 to 2021.03.01

  2. 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

  3. smoking, diabetes

    Yes or No. Checking the admission record for a history of smoking and diabetes.

    Measured: 2014.03.01 to 2021.03.01

  4. operation approach

    Open or Laparoscopic. Checking the surgery record.

    Measured: 2014.03.01 to 2021.03.01

  5. operation time

    unit: min. Checking the anesthesia record.

    Measured: 2014.03.01 to 2021.03.01

  6. cholecystectomy

    Yes or No. Checking the surgery record to determine if cholecystectomy is complicating.

    Measured: 2014.03.01 to 2021.03.01

  7. 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

  8. 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

  9. length of input and output loops

    unit: cm. Checking the surgery record.

    Measured: 2014.03.01 to 2021.03.01

  10. intestinal anastomosis approach

    End-to-side or Side-to-side. Checking the surgery record.

    Measured: 2014.03.01 to 2021.03.01

  11. 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

  12. lymph node metastasis, lymphovascular invasion, nerve invasion.

    Yes or NO. Checking the postoperative pathological report.

    Measured: 2014.03.01 to 2021.03.01

  13. 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

  14. 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.

  1. First posted9 Jun 2021
  2. Study start1 Mar 2014
  3. Primary completion1 Mar 2021
  4. Study completion1 May 2021

Resources

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)
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.

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.

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