A Nursing Protocol for Risk-Guided Follow-Up After Endoscopic Submucosal Dissection in Early Gastrointestinal Cancer

Summary

This retrospective study developed an exploratory recurrence-risk model and compared model-informed risk-guided with routine follow-up after ESD. Risk-guided follow-up was associated with lower 12-month recurrence and better psychological, self-management, nutritional, satisfaction, and resource-use outcomes, although the nonrandomized design and lack of external validation limit causal and predictive interpretation.

Abstract

Endoscopic submucosal dissection (ESD) is widely used for early gastrointestinal cancer, although postoperative recurrence remains clinically relevant. We conducted a two-stage retrospective cohort study. The model-development cohort included 124 patients treated between January 2022 and January 2023, of whom 22 experienced recurrence. Seven nursing-relevant postoperative indicators were entered into a multivariable logistic regression model. Because several indicators were recorded during postoperative follow-up, the model was interpreted as an exploratory recurrence-risk model rather than a baseline prognostic tool. The apparent area under the receiver operating characteristic curve was 0.922 (95% CI, 0.872-0.972); at a probability threshold of 0.1484, sensitivity was 95.45%, and specificity was 84.31%, while bootstrap internal validation yielded an optimism-corrected AUC of 0.884. A separate retrospective comparative cohort included 84 patients treated in 2024: 42 had received model-informed risk-guided follow-up, and 42 had received routine fixed-interval follow-up. During 12 months, recurrence occurred in 5 of 42 patients (11.90%) and 13 of 42 patients (30.95%), respectively, corresponding to a risk difference of −19.05 percentage points (95% CI, -35.55 to -1.37) and a relative risk of 0.38 (95% CI, 0.15-0.98). Generalized estimating equations showed more favorable changes in psychological status, self-management, and nutritional indicators in the risk-guided group, whereas group-by-time interactions for compliance indicators were not significant. The risk-guided group also had lower measured resource use and higher nursing satisfaction. These findings are observational associations; the limited event count, possible temporal overlap between predictors and recurrence, the absence of external validation, and nonrandomized comparisons limit predictive and causal interpretation.

Introduction

Early gastrointestinal cancer remains a major global health burden, with roughly 2 million new cases reported each year, of which more than 40% occur in China¹. Endoscopic submucosal dissection (ESD) has become a cornerstone treatment because it allows en bloc removal while preserving gastrointestinal anatomy and function, and its uptake in China has been reported to exceed 150,000 procedures annually. However, recurrence is still reported in 15-22% of patients within 1–3 years after ESD, and delayed recognition of recurrent disease may result in nearly 60% of these patients presenting with advanced lesions, thereby adversely affecting long-term outcomes². In routine practice, surveillance is commonly delivered as a fixed schedule (e.g., “6 months-1 year-2 years”)³, largely determined by pathological staging, with limited attention to nursing-intervenable contributors such as dietary adherence and psychological status. Data indicate that this traditional model results in a 30% missed detection rate among high-risk populations and over 40% unnecessary follow-up among low-risk groups, leading to not only wasted medical resources (with redundant per capita annual examination costs exceeding 2,000 RMB) but also increased psychological and economic burdens on patients^4,5.

Previous studies of recurrence after ESD have primarily examined lesion characteristics, histopathology, resection-related factors, Helicobacter pylori status, background mucosal changes, and selected lifestyle factors, and several site-specific risk models have been reported^6,7,8,9. However, nursing-relevant behaviors and care-process indicators have rarely been linked directly to follow-up intensity¹⁰. In the present study, dietary behavior, medication adherence, psychological distress, smoking, glycemic control, and follow-up attendance were regarded as potentially modifiable or monitorable targets, whereas incomplete wound-exudate documentation was treated as a care-process marker rather than a presumed causal determinant of recurrence. Because recurrence mechanisms and surveillance requirements differ among esophageal, gastric, and colorectal lesions, the pooled analysis was considered exploratory.

This study used two retrospective cohorts with distinct purposes: an earlier cohort was used to develop and internally evaluate an exploratory recurrence-risk model, whereas a later cohort was used to retrospectively compare outcomes between patients who received model-informed, risk-guided follow-up and those who received routine, fixed-interval follow-up. The study was intended to examine whether nursing-relevant postoperative indicators could be linked to a practical follow-up pathway, rather than to establish externally validated predictive performance or a definitive causal effect of the intervention.

Protocol

The retrospective review of both cohorts was approved by the Taikang Tongji (Wuhan) Hospital (approval No. 128/06/2025). All data were anonymized before analysis, and informed consent was waived. Clinical trial registration was not required because both cohorts were retrospective, all exposures and follow-up strategies had occurred as part of routine clinical care before data extraction, and no prospective enrollment or research-directed assignment of interventions was undertaken.

Study design

This study used a two-stage retrospective cohort design. The cohort treated between January 2022 and January 2023 was used for model development and bootstrap internal validation, whereas the cohort treated between January and December 2024 was used to retrospectively compare outcomes between patients who received model-informed, risk-guided follow-up and those who received routine, fixed-interval follow-up. The second cohort evaluated the documented care pathway and did not constitute external validation of model performance. Figure 1 presents patient selection for both retrospective cohorts.

Study population

Retrospective cohort

The model-development cohort comprised 124 patients with early gastrointestinal cancer who underwent ESD in the Department of Gastroenterology between January 2022 and January 2023. The inclusion criteria were: (1) pathologically confirmed early esophageal, gastric, or colorectal cancer, classified as T1a or T1b without vascular invasion; (2) first-time ESD with complete R0 resection; (3) postoperative survival of at least 6 months; and (4) complete clinical and nursing records, including the specified dietary, medication, psychological, and follow-up information. The exclusion criteria were: (1) distant metastasis or multiple primary malignant tumors; (2) neoadjuvant chemoradiotherapy; (3) a severe postoperative complication requiring reoperation within 3 months; (4) cognitive impairment or mental illness that precluded follow-up cooperation; and (5) loss to follow-up or incomplete data. No formal a priori sample-size calculation was performed because this was a retrospective model-development cohort, and all eligible records available during the prespecified period were included. For binary clinical prediction models, however, sample-size adequacy depends on the number of outcome events, the number of candidate predictor parameters, anticipated model performance, and the need to limit overfitting, rather than on the total sample size alone. The cohort contained 22 recurrence events across seven predictor parameters, corresponding to 3.1 events per parameter; given this low event-to-parameter ratio, the model was considered vulnerable to coefficient instability and overfitting^11,12.

Retrospective comparative cohort

The retrospective comparative cohort comprised 84 patients with early gastrointestinal cancer who underwent ESD between January and December 2024 and had complete documentation of the follow-up strategy received and the prespecified 12-month outcomes. The inclusion criteria were: (1) pathologically confirmed early esophageal, gastric, or colorectal cancer; (2) ESD performed during the prespecified study period; (3) complete documentation of the follow-up strategy received; and (4) complete 12-month outcome data. The exclusion criteria were: (1) distant metastasis or multiple primary malignant tumors; (2) neoadjuvant chemoradiotherapy; (3) a severe postoperative complication requiring reoperation within 3 months; (4) cognitive impairment or mental illness that precluded follow-up participation; and (5) incomplete follow-up or outcome data. Based on the follow-up strategy documented in the medical and nursing records, 42 patients were classified into the model-informed, risk-guided follow-up group and 42 into the routine, fixed-interval follow-up group. No random allocation, allocation concealment, or research-directed assignment was performed. The cohort size was determined by the number of eligible records with complete 12-month outcome data during the prespecified period; consequently, no prospective power-based sample size calculation was applicable.

Data collection

Retrospective data extraction

Baseline variables included age, sex, body mass index (BMI), and pathological type. Nursing-relevant postoperative indicators were abstracted using the prespecified definitions in the database: high-salt or spicy food intake at least twice per week during the first 3 postoperative months; incomplete daily wound-exudate documentation during the first postoperative month; a Hospital Anxiety and Depression Scale score (HADS)¹³ ≥11 at 1 month; at least two missed doses of sucralfate per week during the first 3 postoperative months; at least two missed follow-up appointments during the first 6 months; smoking at least 10 cigarettes per day for at least 6 months; and a mean fasting blood glucose concentration ≥7.0 mmol/L during the first 3 postoperative months among patients with diabetes. The outcome was recurrence within 12 months, defined as local recurrence or metachronous cancer confirmed by endoscopic biopsy and histopathology. Because the assessment windows for several postoperative indicators overlapped with the recurrence-observation period, temporal precedence could not be verified for every patient; these variables were therefore analyzed as postoperative correlates of recurrence, and the resulting model was not interpreted as a baseline prognostic tool.

Model development and internal validation

Seven binary nursing-relevant variables—high-salt or spicy food intake, incomplete wound-exudate documentation, HADS score ≥11, irregular sucralfate use during the first 3 postoperative months, at least two missed follow-up appointments, smoking exposure, and uncontrolled diabetes—were entered simultaneously into a multivariable logistic regression model. Logistic regression was selected because the outcome was binary and the study sought an interpretable probability equation that could be applied in routine records. Alternative statistical or machine-learning algorithms were not compared because only 22 recurrence events were available, making reliable algorithm development and tuning unlikely. Multicollinearity was assessed using variance inflation factors, with values >5 regarded as unacceptable.

Model discrimination was assessed using the area under the receiver operating characteristic curve, with the 95% confidence interval calculated using the DeLong method. The operating threshold was selected by maximizing the Youden index, after which sensitivity and specificity were calculated. Calibration was evaluated using the Hosmer-Lemeshow goodness-of-fit test, the Brier score, and a calibration plot based on predicted risk quintiles. Apparent and bootstrap-corrected calibration were displayed, with optimism estimated from 1,000 bootstrap resamples in which the full model was refitted; the same bootstrap procedure was used to estimate optimism in the AUC¹⁴. Regression coefficients, odds ratios, confidence intervals, the intercept, and the complete probability equation were reported to permit independent calculation of the model score.

Intervention protocol

Risk-guided follow-up group: Medical and nursing records indicated that patients in this group had received follow-up and nursing support linked to the model-derived recurrence probability. The probabilities were categorized using the operational thresholds retained in the original institutional pathway: low risk, <20%; intermediate risk, 20% to <40%; and high risk, ≥40%. These thresholds reflected local clinical practice and multidisciplinary review rather than cutoffs derived from a published guideline, previous validation study, or formal Delphi consensus; they were used to determine nursing intensity and were distinct from the ROC-derived threshold of 0.1484, which was used solely to summarize model sensitivity and specificity.

The pathway was implemented through routine follow-up by gastroenterology nursing staff. Low-risk patients received one annual review, a standardized booklet covering diet, daily lifestyle, and warning symptoms, and brief reinforcement messages every 3 months. Intermediate-risk patients received semi-annual review, including one outpatient endoscopic reassessment, together with monthly nurse-led telephone contacts, review of food diaries, individualized dietary plans, and reinforcement of medication adherence. High-risk patients received an eight-session structured cognitive-behavioral support program delivered once weekly, video-based wound-care instruction, daily recording of bleeding, pain, abdominal distension, and other warning symptoms, weekly submission of the records to the nursing team, monthly family meetings to clarify supervision responsibilities, and coordinated diabetes management with endocrinology consultation and scheduled glucose monitoring.

The archived pathway described the psychological component as cognitive behavioral therapy (CBT) but did not retain the provider’s mental-health credentials or a treatment manual; it is therefore reported conservatively as structured cognitive-behavioral support rather than formal therapist-delivered CBT. The risk-guided follow-up pathway was developed primarily as a local institutional pathway, drawing on the hospital’s routine post-ESD procedures and published recommendations supporting scheduled endoscopic surveillance after curative ESD^15,16. The published guidance informed the general surveillance framework but did not specify the model-based probability thresholds or the nursing actions assigned to each risk tier. These elements were developed locally by mapping nursing-relevant indicators to corresponding care actions and were reviewed by the hospital’s multidisciplinary clinical team without a formal Delphi process. Delivery was documented in the existing nursing and follow-up records; no separate fidelity checklist, prespecified fidelity threshold, or independent fidelity assessment was retained (Table 1).

Routine follow-up group: Records indicated that patients in this group had received fixed-interval follow-up, including endoscopic examinations at 6 months, 1 year, and 2 years after surgery, as well as routine health education without model-informed, individualized guidance.

Outcome indicators

Model performance indicators

Model performance was summarized using the AUC and its 95% confidence interval; the selected probability threshold; sensitivity, specificity, and the Youden index; the Hosmer-Lemeshow statistic and P value; the Brier score; bootstrap-estimated optimism; and the optimism-corrected AUC.

Comparative outcome in the retrospective comparative cohort

The principal comparative outcome was recurrence confirmed by endoscopic biopsy and histopathology within 12 months after ESD. Results were reported as absolute numbers and percentages, together with the risk difference, relative risk, odds ratio, and their 95% confidence intervals. Exact recurrence dates were not retained in the 2024 analysis dataset; therefore, recurrence-free survival, Kaplan-Meier curves, Cox regression, and recurrence-time distributions were not analyzed.

Nursing management quality indicators

Nursing compliance was evaluated at 1, 6, and 12 months and included dietary compliance, defined as high-salt or spicy food intake fewer than twice per week; wound-care execution, defined as completion of standardized daily wound records; medication adherence, defined as fewer than two missed doses per week; and follow-up adherence, defined as no missed scheduled appointments.

Psychological status was assessed at the same time points using the Chinese version of the 14-item Hospital Anxiety and Depression Scale, which comprises 7-item anxiety and depression subscales, each scored from 0 to 21, with higher scores indicating greater symptom burden. Anxiety, depression, and total scores were analyzed as continuous variables. The Chinese version of the HADS has demonstrated satisfactory psychometric properties, including construct validity, internal consistency, and concurrent validity, in a multicenter sample of Chinese cancer patients¹³.

Self-management was assessed using the Gastrointestinal Disease Self-Management Scale recorded in the original study database. The retained scale comprised four scored domains—dietary management, symptom monitoring, medication management, and emotional regulation—and a total score calculated as the sum of the four domain scores; higher scores indicated better self-management. The original study documentation recorded a Cronbach’s α of 0.85. Item-level responses, the original instrument manual, and an independent external validation reference were not retained; the scale was therefore treated as a study instrument rather than described as a fully externally validated measure.

Nursing satisfaction was assessed at 12 months using the hospital-developed 100-point satisfaction scale recorded in the study database. Scores were categorized as very satisfied (≥90), satisfied (80–89), fair (60-79), or dissatisfied (<60). The original study documentation reported a Cronbach’s α of 0.87, but item-level responses and the original scale-development records were not retained; therefore, satisfaction findings were considered exploratory.

Medical resource efficiency indicators

Resource use was evaluated over the 12-month observation period from a hospital direct medical resource perspective. Examination costs were expressed in nominal Chinese yuan as recorded in the hospital database and included charges for endoscopic, imaging, and laboratory examinations; no inflation adjustment or discounting was applied because the analysis covered a single 12-month follow-up period. Hospitalizations attributable to recurrence or postoperative complications were identified from the electronic medical records. Follow-up time was analyzed using the composite variable retained in the database, which combined healthcare provider follow-up time with patient travel and consultation time; the individual time components were not stored separately. Because cost and utilization variables may be skewed, between-group mean differences and 95% confidence intervals were estimated using 10,000 nonparametric bootstrap resamples.

Statistical methods

Data were analyzed using SPSS and R. Continuous single-time-point variables were assessed for normality using the Shapiro-Wilk test and summarized as mean ± standard deviation or median (interquartile range), as appropriate. Between-group comparisons used independent-samples t tests or Mann-Whitney U tests. Categorical variables were summarized as n (%) and compared using Pearson’s χ² test or Fisher’s exact test when expected cell counts were <5. Ordered satisfaction categories were compared using the Mann-Whitney rank-sum test, while the overall satisfaction rate was compared using Fisher’s exact test.

Repeated continuous outcomes were analyzed using generalized estimating equations with a Gaussian distribution, identity link, exchangeable working correlation, and robust standard errors; fixed effects comprised group, time, and the group-by-time interaction. Repeated binary compliance outcomes were analyzed using generalized estimating equations with a binomial distribution and logit link. Group-by-time interaction P values were adjusted within each outcome family using the Benjamini-Hochberg false-discovery-rate procedure, and 12-month between-group differences or odds ratios were reported with 95% confidence intervals.

One missing 6-month self-management total score in the routine-follow-up group was reconstructed as 72 because all four domain scores were available and summed exactly to that total. Recurrence comparisons were reported using the risk difference, relative risk, and odds ratio with 95% confidence intervals. Resource-use mean differences and confidence intervals were estimated using 10,000 nonparametric bootstrap resamples. The seven-variable logistic model was evaluated using the procedures described above, including 1,000 bootstrap resamples for internal validation. Because the comparative cohort was nonrandomized and contained only 18 recurrences, its results were interpreted as unadjusted observational associations rather than causal effect estimates. All tests were two-sided, and p < 0.05 was considered statistically significant.

Results

Univariate associations between nursing-relevant indicators and recurrence

Among the 124 patients in the model-development cohort, 22 experienced recurrence and 102 did not. High-salt or spicy food intake, incomplete wound-exudate documentation, HADS score ≥11, irregular sucralfate use, at least two missed follow-up appointments, smoking exposure, and uncontrolled diabetes were more frequent among patients with recurrence than among those without recurrence. Age, BMI, le...

Discussion

This study examined whether nursing-relevant postoperative indicators could be incorporated into an exploratory recurrence-risk model and linked to a practical follow-up pathway. In the retrospective development cohort, the seven-variable model showed high apparent discrimination, although its limited event count, temporal overlap between several indicators and recurrence, and absence of external validation preclude firm conclusions regarding predictive transportability. A separate retrospective comparative cohort allowe...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Automatic biochemical analyzer	Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China	BS-240 Pro	Measurement of serum albumin and hemoglobin
CO2 insufflator	Micro-Tech (Nanjing) Co., Ltd., Nanjing, China	CO2-300	Used to reduce postoperative discomfort during endoscopy
Electronic endoscope system	Olympus (China) Co., Ltd., Beijing, China	EVIS X1 (CV-1500)	Used for diagnostic endoscopy and postoperative surveillance after ESD
Electronic medical record system (EMR)	Winning Health Technology Group Co., Ltd., Nanjing, China	HIS-V8.0	Extraction of clinical and nursing data
Electronic weighing scale	Xiaomi Communications Co., Ltd., Beijing, China	XMTZC05HM	Measurement of body weight for BMI calculation
Endoscopic clipping device	Micro-Tech (Nanjing) Co., Ltd., Nanjing, China	HX-610-135	Hemostasis and wound closure after ESD
Endoscopic submucosal dissection knife	Micro-Tech (Nanjing) Co., Ltd., Nanjing, China	KD-650Q	Standard ESD knife for lesion resection
Gastrointestinal Disease Self-Management Scale	Chinese version	N/A	Assessment of self-management ability
High-frequency electrosurgical generator	Shanghai Hutong Electric Co., Ltd., Shanghai, China	GD-350-B	Provides cutting and coagulation during ESD
Hospital Anxiety and Depression Scale (HADS)	Chinese validated version	N/A	Psychological assessment of anxiety and depression
Proton pump inhibitor (PPI)	Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, China	H20051628	Acid suppression after ESD
R statistical software	R Core Team	R 4.3.1	Bootstrap internal validation and statistical analysis
Statistical analysis software	IBM SPSS	SPSS 26.0	Statistical analysis of study data
Sucralfate oral suspension	CSPC Pharmaceutical Group Ltd., Shijiazhuang, China	H13023653	Post-ESD mucosal protection and ulcer healing