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出境医 / 临床实验 / Predictive Factors for Roux Stasis Syndrome (PFRSS)

Predictive Factors for Roux Stasis Syndrome (PFRSS)

Study Description
Brief 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. "R" package was used to build a nomogram.

Condition or disease Intervention/treatment
Gastrostomy Diagnostic Test: X-ray

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Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Factors for Roux Stasis Syndrome After Distal Gastrectomy With Roux-en-Y Reconstruction in Gastric Cancer Patients: A Retrospective Comparative Cohort
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : May 1, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
RSS- Group
Patients without RSS after distal gastrectomy.
Diagnostic Test: X-ray
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.
Other Name: CT and Upper Gastroenterography

RSS+ Group
Patients with RSS after distal gastrectomy.
Diagnostic Test: X-ray
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.
Other Name: CT and Upper Gastroenterography

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Age [ Time Frame: 2014.03.01 to 2021.03.01 ]
    unit: years. Checking the admission record.

  2. body mass index (BMI) [ Time Frame: 2014.03.01 to 2021.03.01 ]
    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.

  3. smoking, diabetes [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking the admission record for a history of smoking and diabetes.

  4. operation approach [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Open or Laparoscopic. Checking the surgery record.

  5. operation time [ Time Frame: 2014.03.01 to 2021.03.01 ]
    unit: min. Checking the anesthesia record.

  6. cholecystectomy [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking the surgery record to determine if cholecystectomy is complicating.

  7. high carcinoembryonic antigen (CEA) [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking preoperative laboratory values, if CEA < 5.0 ng/ml choose No, if CEA ≥ 5.0 ng/ml, choose Yes.

  8. hypoproteinemia [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking preoperative laboratory values, if albumin < 30.0 g/l choose Yes, if albumin ≥ 30.0 g/l , choose No.

  9. length of input and output loops [ Time Frame: 2014.03.01 to 2021.03.01 ]
    unit: cm. Checking the surgery record.

  10. intestinal anastomosis approach [ Time Frame: 2014.03.01 to 2021.03.01 ]
    End-to-side or Side-to-side. Checking the surgery record.

  11. pathological T (pT) stage [ Time Frame: 2014.03.01 to 2021.03.01 ]
    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.

  12. lymph node metastasis, lymphovascular invasion, nerve invasion. [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or NO. Checking the postoperative pathological report.

  13. postoperative hospital stay [ Time Frame: 2014.03.01 to 2021.03.01 ]
    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.

  14. Gender [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Male or Female. Checking the admission record.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
General Surgery Department, Peking University Third Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wei Fu, MD General Surgery Department, Peking University Third Hospital
Principal Investigator: Xin Zhou, MD eneral Surgery Department, Peking University Third Hospital
Tracking Information
First Submitted Date May 27, 2021
First Posted Date June 9, 2021
Last Update Posted Date June 9, 2021
Actual Study Start Date March 1, 2014
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2021)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 2, 2021)
  • Age [ Time Frame: 2014.03.01 to 2021.03.01 ]
    unit: years. Checking the admission record.
  • body mass index (BMI) [ Time Frame: 2014.03.01 to 2021.03.01 ]
    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.
  • smoking, diabetes [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking the admission record for a history of smoking and diabetes.
  • operation approach [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Open or Laparoscopic. Checking the surgery record.
  • operation time [ Time Frame: 2014.03.01 to 2021.03.01 ]
    unit: min. Checking the anesthesia record.
  • cholecystectomy [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking the surgery record to determine if cholecystectomy is complicating.
  • high carcinoembryonic antigen (CEA) [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking preoperative laboratory values, if CEA < 5.0 ng/ml choose No, if CEA ≥ 5.0 ng/ml, choose Yes.
  • hypoproteinemia [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or No. Checking preoperative laboratory values, if albumin < 30.0 g/l choose Yes, if albumin ≥ 30.0 g/l , choose No.
  • length of input and output loops [ Time Frame: 2014.03.01 to 2021.03.01 ]
    unit: cm. Checking the surgery record.
  • intestinal anastomosis approach [ Time Frame: 2014.03.01 to 2021.03.01 ]
    End-to-side or Side-to-side. Checking the surgery record.
  • pathological T (pT) stage [ Time Frame: 2014.03.01 to 2021.03.01 ]
    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.
  • lymph node metastasis, lymphovascular invasion, nerve invasion. [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Yes or NO. Checking the postoperative pathological report.
  • postoperative hospital stay [ Time Frame: 2014.03.01 to 2021.03.01 ]
    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.
  • Gender [ Time Frame: 2014.03.01 to 2021.03.01 ]
    Male or Female. Checking the admission record.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictive Factors for Roux Stasis Syndrome
Official Title Predictive Factors for Roux Stasis Syndrome After Distal Gastrectomy With Roux-en-Y Reconstruction in Gastric Cancer Patients: A Retrospective Comparative Cohort
Brief 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. "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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Gastrostomy
Intervention Diagnostic Test: X-ray
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.
Other Name: CT and Upper Gastroenterography
Study Groups/Cohorts
  • RSS- Group
    Patients without RSS after distal gastrectomy.
    Intervention: Diagnostic Test: X-ray
  • RSS+ Group
    Patients with RSS after distal gastrectomy.
    Intervention: Diagnostic Test: X-ray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2021)
220
Original Actual Enrollment Same as current
Actual Study Completion Date May 1, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04919577
Other Study ID Numbers PekingUTH M2019173
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: We may upload our raw data to Mendeley Data after accepted.
Responsible Party Wei Fu, Peking University Third Hospital
Study Sponsor Peking University Third Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Wei Fu, MD General Surgery Department, Peking University Third Hospital
Principal Investigator: Xin Zhou, MD eneral Surgery Department, Peking University Third Hospital
PRS Account Peking University Third Hospital
Verification Date June 2021