Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04919577 |
| Other study ID # |
PekingUTH M2019173 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2014 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Peking University Third Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. "R" package was used to build a nomogram.
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.
