Introduction

In obese patients, a large amount of data shows that bariatric therapy with Bioenterics intragastric balloon (BIB) results in weight loss in some patients. However there is paucity of data about predictive risk factors for BIB success.

Aims & Methods

The aim of this study was to determine the impact of age and gender in the effectiveness of this endoscopic device for weight loss.
Single center prospective study with 187 patients, 143 (76.5%) females, mean age 40±11.9 years submitted to BIB therapy. Data were collected for age, gender, baseline weight and baseline BMI. At BIB removal, after 41.3±12.1 weeks, the following parameters were documented: % excess weight loss (%EWL), total body weight loss (TBWL) and % total body weight loss (%TBWL). Patients were categorized according to gender, age groups (<40 years, between 40 – 49 years and age ≥ 50 years), and according to baseline BMI (<35 kg/m², 35-40 kg/m² and >40 kg/m²).
Multiple linear regression analysis was used to assess the effect of baseline BMI, gender and age in the BIB outcomes (p<0.05).

Results

Median TBWL was 14 kg (16.0±12.2kg) in female and 14.5 kg (15.8±11.7kg) in male (p=0.994). Female with ≥50 years lost significantly more TBWL than female with <40 years and female between 40-49 years, respectively 22.5 kg vs 11.5kg median values (p=0.028) and 22.5 kg vs 13.3 kg (p=0.037). Regarding %TBWL there were significant differences between the age groups: female with ≥50 years vs <40 years (21.2% vs 13.2%,p=0.018), but no significant differences were observed between the female with 40-49 years and the younger and older ones (<40 vs 40-49 years, p=0.853; 40-49 vs ≥50 years, p=0.058). The %EWL was not significant different in the female groups (p=0.355). In the male group the 3 endpoints were not significantly different: TBWL, p= 0.621, % TBWL p=0.835 and % EWL p=0.888. Patients with higher baseline BMI (> 40) had significantly more TBWL in both genders, female (p=0.001) and male (p=0.002), significantly more %TBWL in male (p=0.033) and significantly more% EWL in female (p=0.049).

Conclusion

Older female patients (≥ 50 years) lost greater amount of weight than younger ones with BIB therapy. On the other hand, age did not alter the outcome in male patients. Higher baseline BMI was significantly correlated with greater weight loss in both genders. Age and baseline BMI can be used as predictors of weight loss in patients submitted to BIB therapy.

Introduction

Obesity has reached pandemic proportions. According to the World Health Organization, 16% of the global adult population, or about 890 million people, have obesity(1). Intragastric balloon (IGB) is an alternative method to induce weight loss in subjects with obesity. However, not all subjects tolerate an IGB, and up to 15% of the cases, the IGB may be removed early due to intolerability(2). The factors that predict IGB tolerability remain poorly studied. In this study, we investigated whether there is an association between the baseline gastric emptying rate and IGB tolerability.

Aims & Methods

Twenty-eight subjects with a Body Mass Index (BMI) over 27.5 kg/m² were included. Orbera 365® IGBs were endoscopically inserted and filled with 550 ml saline solution and scheduled for removal after 12-months. Before insertion, the subjects underwent a standardized, FDA-approved 13C-Spirulina breath test to measure their gastric emptying half-time (T1/2). Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) at baseline and at 4, 8, 16, and 24 weeks post-insertion, even after eventual early IGB removal.

Results

Six subjects had their IGBs removed earlier than planned due to tolerance issues, which we define as early removal. Early removal in our study refers to any removal that occurred before the planned 12-months. The specific timepoints of removal varied: one at four weeks, two at six months, one at eight months, and two at eleven months.
In the group that had their IGB removed earlier, the median baseline GSRS score was 28 (range 23-41), with a median T1/2 of 81.4 min (range 38.4-140.1). The median GSRS score at 4 weeks was 55.5 (range: 42-72), at 8 weeks 45 (range: 19-82), at 16 weeks 45.5 (range: 19-31), and at 24 weeks 37 (range 22-61).
In the group that tolerated the IGB, the median baseline GSRS score was 28 (range 19-77), with a median T1/2 of 61 min (range 34.5-108.4). The median GSRS score at 4 weeks was 53 (range: 24-133); at 8 weeks 37.5 (range: 19-79); at 16 weeks 37 (range: 21-85), and at 24 weeks 37 (range 19-104), respectively.
No statistically significant differences were observed in half-times (T1/2) and GSRS scores between the two groups at the examined time points. The p-value for T1/2 was 0.09. For GSRS, p-values were as follows: 0.89 at baseline, 0.63 at 4 weeks, 0.87 at 8 weeks, 0.45 at 16 weeks, and 0.73 at 24 weeks. Additionally, correlation analysis between GSRS scores and T1/2 values showed no significant relationships at baseline (p = 0.50), 4 weeks (p = 0.89), 8 weeks (p = 0.93), 16 weeks (p = 0.983), and 24 weeks (p = 0.86). These results suggest a consistent lack of significant association across all time points.

Conclusion

Early IGB removal cannot be predicted by the baseline gastric emptying rate or baseline GSRS in our study. The GSRS scores for subjects that tolerated the IGB, regardless of the time point, do not correlate with their baseline gastric emptying rate.

References

1. World Health Organization. (2022). Obesity and overweight. Retrieved from https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
2. Jamal MH, Al-Kanawati N, ElAbd R, et al. A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss. Obesity Surgery 2021: 31(12); 5342–5347. https://doi.org/10.1007/s11695-021-05729-8

Introduction

Post-procedural bleeding (PPB) is the most common adverse event after gastric endoscopic submucosal dissection (ESD). The BEST-J score was created to predict PPB risk following gastric ESD.

Aims & Methods

We aimed to evaluate predictive factors of PPB and validate the BEST-J score in a large European cohort. We conducted a retrospective cohort study including consecutive gastric epithelial lesions removed by ESD between January of 2005 and June of 2024. Incomplete ESD and patients with missing information that prevented the score calculation were excluded. PPB was defined as presence of compatible clinical picture in the 28 days following the procedure. Univariate and multivariate analysis were used to identify predictive factors of PPB, and the diagnostic ability of the BEST-J score was calculated in this cohort.

Results

From 990 ESD, 874 were included in the final analysis. PPB occurred in 53 patients (6.1%), with a median time after procedure of 2 days (P25-P75: 1-7). PPB was significantly superior in patients with higher risk as evaluated by the BEST-J score (PPB rate of 3.7%, 3.9%, 19.2% and 35.7% for low, intermediate, high and very-high risk, respectively). The area under the curve for PPB prediction using the BEST-J score was 0.684 (IC95% 0.598-0.679). For a score ≥ 3 (high and very-high risk), the sensitivity and specificity for PPB detection were 47.2% (IC95% 34.2-60.5) e 88.7% (IC95% 86.4-90.7), respectively. In this sample, the following predictive factors for PPB were identified: ischemic cardiopathy [adjusted Odds Ratio (aOR) 4.351; IC95% 1.660-11.404], medication with warfarin (aOR 18.339; IC95% 4.541-74.064) or direct oral anticoagulants (aOR 7.596; IC95% 2.666-21.641) and lesion size > 20mm (aOR 2.563; IC95% 1.246-5.272).

Conclusion

The BEST-J score presented moderate discrimination for PPB following gastric ESD in our cohort. The identified factors may assist the decision of implementing prophylactic measures in high-risk patients and the creation of more precise prediction models.

References

Vasconcelos AC, et al. Endoscopic Resection of Early Gastric Cancer and Pre-malignant Gastric Lesions. Cancers, 2023 Jun 7;15(12):3084. doi: 10.3390/cancers15123084.
Hatta W, et al. Prediction model of bleeding after endoscopic submucosal dissection for early gastric cancer: BEST-J score. Gut, 2021 Mar;70(3):476-484. doi: 10.1136/gutjnl-2019-319926

Introduction

Esophageal variceal bleeding (EVB) is a severe complication of liver cirrhosis. An effective prophylactic intervention and treatment option in EVB is endoscopic band ligation (EBL). An average post-banding bleeding (PBB) rate of approximately 3.5% within two weeks post-intervention has been reported¹. This study aims to assess the risk of bleeding after EBL of esophageal varices and to identify patient-specific and procedure-related risk factors for PBB.

Aims & Methods

For risk stratification, a retrospective analysis was conducted on 233 patients who underwent ligation therapy for esophageal varices at a tertiary care centre between January 2019 and February 2023. In total, 616 ligation therapies were analysed with regard to the occurrence of PBB within 21 days post-intervention. Data collected included laboratory parameters, type and severity of underlying liver disease, recent alcohol consumption, anticoagulant use, and procedural details such as the number of bands applied and intra-procedural bleeding. Data was analysed using R and SPSS statistical software.

Results

In our study, PBB occurred in 30 of 616 EBL procedure (4.9%). Importantly, for interventions to treat acute variceal bleedings, the PBB rate was 20.8% (16/77 cases), whereas ligature in patients without acute bleeding had a low PBB rate of only 2.6% (14/539 cases, p<0.001). Additionally, recent alcohol abuse within 28 days prior to the procedure was reported in 50% (15/30) of interventions with PBB, whereas alcohol abuse was observed in only 20.3% (119/586) of non-PBB cases (p < 0.001). Furthermore, impaired liver function assessed by Child-Pugh and MELD scores was associated with an increased risk of PBB (p < 0.001). Conversely, low platelet counts below 50 G/L or even below 30 G/L did not show a significant increase in the occurrence of PBB in our patient cohort, suggesting that EBL can be safely performed in patients with platelet counts < 50 G/L². Additionally, the use of acetyl salicylic acid (ASA) was not associated with a significantly higher incidence of PBB in this cohort.

Conclusion

While the overall risk of PBB following EBL is relatively low, we could identify several risk factors that increased the likelihood of esophageal variceal bleeding following EBL. Relevant risk factors were ligature for acute EVB, impaired liver function, and active alcohol abuse. In contrast, patients with low platelet counts (<50 G/L) or those taking ASA medication did not show an increased risk of PBB in our cohort. These findings allow for a more precise risk stratification for PBB and will be useful to assess which patients require extended in-hospital observation after EBL and who can be safely discharged shortly after the procedure.

References

1. Vanbiervliet G, Giudicelli-Bornard S, Piche T, et al. Predictive factors of bleeding related to post banding ulcer following endoscopic variceal ligation in cirrhotic patients: a case-control study. Aliment Pharmacol Ther. 2010;32(2):225-232
2. Katsumi, T. and Y. Ueno, Prospects for treatment of esophageal varices considering the safety of endoscopic band ligation. Hepatology International, 2023. 17(5): p. 1079-1081

Introduction

The latest ESGE technical review guideline advocates real-time monitoring in the first hour of small bowel capsule endoscopy (SBCE) to ensure entire small bowel visualization. However, a survey demonstrated poor adherence to this statement in clinical practice, and supporting data are scarce.

Aims & Methods

We aimed to evaluate predictive factors of incomplete SBCE and to ascertain the importance and cost-effectiveness of real-time monitoring.
We retrospectively included consecutive patients who ingested SBCE (PillCam SB3) at our tertiary referral center from 2013 to 2020. Clinical and endoscopic characteristics were analyzed. Real-time monitoring was not applied according to local protocol. Prolonged gastric transit time (GTT) was defined when the capsule crossed the pylorus > 2 hours from ingestion, and prolonged small bowel transit time (SBTT) when cecum was reached > 6 hours from pylorus crossing. A logistic regression analysis was done to find significative risk factors associated with incomplete SBCE. Exclusion criteria included: capsule retention, endoscopic delivery of capsule, and major technical issues (i.e., eating within a standard gastric transit time of the capsule or major recording issues).

Results

A total of 859 SBCE were analyzed, with a completion rate of 94.5%. A prolonged GTT and a prolonged SBTT were found in respectively 46 (5.4%) and 152 (17.6%) procedures. At multivariate analysis, one modifiable (prolonged GTT[p=0.02]) and two unmodifiable risk factors (inpatient status [p<0.01] and history of incomplete SBCE [p=0.02]) were associated with a higher rate of incomplete SBCE, with increased odds ratio of 3.0 (CI95%= 1.2-7.4), 2.3 (CI95%= 1.2–4.2), and 3.7 (CI95%= 1.2-11.9), respectively. Pretest probability of SBCE completion rate was 90.5% and 95.7% in patients with and without unmodifiable risk factors (p=0.01).
Considering the rates of prolonged GTT, the number of patients to be monitored with real-time viewer to identify and treat one patient with prolonged GTT is 14.5 in patients with unmodifiable risk factors for incomplete SBCE and 20.3 in patients without risk factors for incomplete SBCE (p=0.27).
Direct cost for 1-hour real-time monitoring and intervention in case of prolonged GTT (i.e., dedicated room, nurse, +/- metoclopramide and IV access) are equal to circa 35 €. If all patients of our cohort would undergo real-time monitoring, the expense would be equal to 30065 €. Given that in our cohort 6 patients had an incomplete SBCE, the cost of RTM to prevent one incomplete SBCE would be equal to 5010 €. If RTM would be limited to patients with unmodifiable risk factors for incomplete SBCE, the total cost would be equal to 6615 €. In this sub-group only 2 patients had an incomplete SBCE, therefore, to prevent one incomplete SBCE, the total expense would be 3307 €.

Baseline Characteristics	Incomplete SBCE Patients number = 47	Complete SBCE Patients number = 812	p-value
Age (median, years)	63.0 (IQR 50.0 – 70.0)	58.0 (IQR 42.0 – 72.0)	0.36
Female	61.7% (29)	60.6% (492)	1
Inpatient	36.2% (17)	19.2 % (156)	<0.01*
Diabetes Narcotics ESKD Neurological disorders Small bowel Crohn’s disease	10.6% (5) 8.5% (4) 2.1% (1) 4.3% (2) 2.1% (1)	9.7% (79) 5.2% (42) 5.8% (47) 4.1% (33) 1.1% (9)	0.80 0.31 0.51 1 0.43
Prolonged gastric transit time	12.8% (6)	4.9% (40)	0.02*
Previous incomplete SBCE	8.5% (4)	2.1% (17)	0.02*

Conclusion

The inpatient status, a prolonged GTT and a previous incomplete SBCE are risk factors for incomplete SBCE. According to our direct costs analysis, the number needed to treat one prolonged GTT to decrease the rate of incomplete SBCE appears to be cost-effective in patients with unmodifiable risk factors (i.e., inpatient status and history of incomplete SBCE).

Introduction

Delayed bleeding after gastric endoscopic submucosal dissection (ESD) is a serious complication in older adults. The BEST-J score, developed by Hatta et al. (Gut, 2021), is widely used for bleeding risk stratification but does not reflect systemic factors. The Prognostic Nutritional Index (PNI), calculated as [10 × serum albumin (g/dL)] + [0.005 × total lymphocyte count (/μL)], may complement this score. This study evaluated whether combining PNI with the BEST-J score improves risk stratification.

Aims & Methods

We retrospectively analyzed 252 patients who underwent gastric ESD between April 2016 and February 2025, including 127 older (≥75 years) and 125 younger (<75 years) individuals. Patients were classified into low (<40) and high (≥40) PNI groups. The association between delayed bleeding, PNI, and BEST-J score was analyzed using receiver operating characteristic (ROC) analysis. To evaluate internal validity, we conducted 5-fold cross-validation of a logistic regression model that added 1 point for PNI < 40 to the BEST-J score. A cutoff value of PNI < 40 was used, based on previously reported clinical thresholds reflecting impaired nutritional and immune status, including its predictive value for bleeding in various clinical settings (Zhao et al., 2024; Lin et al., 2021).

Results

The delayed bleeding rate was 4.7% in the older group and 0.8% in the younger group. Mean PNI was lower in bleeding cases (44.7) than in non-bleeding cases (48.5). Among older adults, the AUCs for PNI and BEST-J alone were 0.65 and 0.72, respectively. Adding 1 point for PNI < 40 improved the AUC to 0.82. Cross-validation confirmed good model reproducibility, with a mean AUC of 0.861 and standard deviation of 0.147, indicating stable predictive performance without overfitting. The inclusion of PNI < 40 enhanced model sensitivity for identifying bleeding cases without substantially compromising specificity, improving clinical applicability. These associations were most prominent in older patients, supporting age-specific application of the combined model.

Conclusion

The combination of BEST-J and PNI provides an improved and practical approach to risk stratification for delayed bleeding after gastric ESD in older adults. Cross-validation supports the model's internal validity and suggests applicability to broader clinical populations. Given the disproportionately higher bleeding risk in the older cohort, our findings underscore the importance of incorporating host-related factors such as nutrition into stratification strategies specifically in this age group.

References

1. Hatta W, Tsuji Y, Yoshio T, et al. Prediction model of bleeding after endoscopic submucosal dissection for early gastric cancer: BEST-J score. Gut. 2021;70(3):476–484. doi:10.1136/gutjnl-2019-319926.
2. Zhao Y, Chen X, Zhang M, et al. Association of Prognostic Nutritional Index with Post-Discharge Bleeding in Acute Coronary Syndrome Patients on Dual Antiplatelet Therapy. Front Cardiovasc Med. 2024;11:11995920.
3. Lin Y, Wang J, Chen Z, et al. Preoperative Prognostic Nutritional Index Predicts Intraoperative Transfusion and Surgical Outcomes in Hepatocellular Carcinoma Patients Undergoing Hepatectomy. Cancers (Basel). 2021;13(11):2508.

Introduction

Massive gastrointestinal bleeding (MGB) is a life-threatening condition that requires prompt recognition and resuscitation to increase the chance of good outcomes (1).

Aims & Methods

Aims: Analyze risk factors, comorbidities and outcomes of MGB.
Methods: Retrospective analysis of a prospective registry of upper gastrointestinal bleed (UGIB) patients admitted to ‘Virgen de las Nieves University Hospital’ between 2013-2020.
MGB was defined as UGIB with transfusion of >2 pRBCs in the emergency room or during the first 24h of hospital stay and signs of shock (2). Main outcomes were 30-day mortality, rebleeding, bleeding persistence or severe complication throughout admission and complications within the first 6 months after discharge (including cardiovascular, hemorrhagic or deaths).
Statistical analysis was performed by SPSS.

Results

We included 1213 UGIB patients, 171 with MGB.
Multivariate logistic regression analysis showed that, being admitted for another condition (HR 1.72,95%CI 1.04-2.58,p=0.035), having a systemic disease (HR 2.30,95%CI 1.22-5.32,p=0.045), a disseminated malignancy (HR 2.07,95%CI 1.02-4.21,p=0.045) or suffering a severe comorbidity (HR 2.21,95%CI 1.25-3.91,p=0.009) were independent risk factor for MGB.
Among 171 MGB patients, 21% died, with 10 deaths directly from hypovolemic shock secondary to UGIB, and 11% due to complications.
Table shows significance differences between deaths and survivors.

Relevant Comorbidities ASA 3-4 (%)	Deaths 96.7%	Survivors 78.5%	p 0.0018
Active bleeding (%)	76.3	43.3	0.007
Interventional radiology (%)	13.3	3.7	0.034
SBP (mean±SD mmHg)	79±8	84±9	0.025
Albumin (mean±SD mg/dl)	2.4±0.5	2.8±0.6	0.011
Calcium (mean±SD mg/dl)	7.7±0.6	8.2±0.8	0.032
Platelets (mean±SD /mm3)	158*103±101*103	206*103±106*103	0.027
Severe complications during hospitalization	76.7	22.1	<0.0001
Bleeding persistence (%)	63.3	17.6	<0.0001
Rebleeding (%)	40	17	0.005

Multivariate analysis showed that active bleeding in endoscopy (HR 4.80,95%CI 1.06-21.62,p=0.041) and severe complications (HR 14.03,95%CI 3.30-59.60,p<0.0001) were independent predictors for mortality, being calcium levels a protective factor (HR 0.41,95%CI 0.16-0.94,p=0.045).
Among the survivors after the index episode,14% died after 6 months, being main causes of death recurrent bleeding(5.2%), neoplasms(4.4%), cirrhosis complications(2%), cardiovascular disease(1.5%) and sepsis(1.5%).
Delayed bleeding was caused by recurrent UGIB in 86.6%, lower GIB in 10% and from a non-GI origin in 3.4%. Delayed cardiovascular events were heart failure in 46%, thromboembolic events in 23%, myocardial ischemia in 15.4% and atrial fibrillation in 15.6%.

Conclusion

Our study is a prospectively collected single center registry of patients with massive UGIB, in which we observed that being an inpatient and harboring severe comorbidities, particularly systemic diseases and malignancies, were risk factors for this condition. Mortality among those patients was related to CKD, cirrhosis, severe comorbidities and excessive alcohol consumption. We also found an increased delayed mortality, probably related to a worsening health condition in which GI bleeding heralded poor outcomes, some of them potentially preventable with close follow-up.

References

1. Nagata N, Sakurai T, Shimbo T, et al. Acute Severe Gastrointestinal Tract Bleeding Is Associated With an Increased Risk of Thromboembolism and Death. Clin Gastroenterol Hepatol. 2017;15:1882-1889 e1881.
2. D'Amore K, Swaminathan A. Massive Gastrointestinal Hemorrhage. Emerg Med Clin North Am. 2020;38:871-889.