Interventional gastroenterology in oncology.

Cancer is one of the foremost health problems worldwide and is among the leading causes of death in the United States. Gastrointestinal tract cancers account for almost one third of the cancer-related mortality globally, making it one of the deadliest groups of cancers. Early diagnosis and prompt management are key to preventing cancer-related morbidity and mortality. With advancements in technology and endoscopic techniques, endoscopy has become the core in diagnosis and management of gastrointestinal tract cancers. In this extensive review, the authors discuss the role endoscopy plays in early detection, diagnosis, and management of esophageal, gastric, colorectal, pancreatic, ampullary, biliary tract, and small intestinal cancers.

Response to botulinum toxin may predict response to peroral pyloromyotomy in patients with gastroparesis.

BACKGROUND : Patients with gastroparesis who have undergone prior intrapyloric botulinum toxin injection (BTI) may seek an opinion regarding peroral pyloromyotomy (POP). There are only two small reports assessing the role of BTI as a predictor for successful treatment with POP. METHODS: We performed a retrospective cohort study to assess whether symptomatic improvement after BTI predicts a response to POP. We included 119 patients who had undergone both BTI and POP at Cleveland Clinic Ohio or Cleveland Clinic Florida from January 2016 to September 2019. RESULTS: 65.5 % of patients had symptomatic improvement after BTI. Gastroparesis Cardinal Symptom Index (GCSI) scores were available for 74 patients, with 64 % achieving a response to POP, defined as a decrease in mean GCSI ≥ 1. In multivariable analysis, response to BTI (odds ratio [OR] 7.7 [95 %CI 2.2-26.1]) and higher pre-POP GCSI score (OR 2.3 [95 %CI 1.2-4.6]) were independent predictors of response to POP. CONCLUSIONS: Clinical improvement after BTI is a predictor of response to POP in patients with gastroparesis. This information may aid in improving patient selection for POP.

Incidence and Prevalence of Intraductal Papillary Mucinous Neoplasms in Individuals With BRCA1 and BRCA2 Pathogenic Variant.

BACKGROUND: The natural history of branch-duct intraductal papillary neoplasm (BD-IPMN) in BRCA1/2 patients is unknown. Our goal was to estimate the incidence and prevalence of BD-IPMN and other pancreatic lesions in BRCA1/2 patients and compare it to that for average-risk individuals. METHODS: We identified a cohort of BRCA1/2 patients followed at our institution between 1995 and 2020. Medical records and imaging results were reviewed to determine prevalence of pancreatic lesions. We then identified those who had undergone follow-up imaging and determined the incidence of new pancreatic lesions. We categorized pancreatic lesions as low, intermediate, or high-risk based on their malignant potential. RESULTS: During the study period, 359 eligible BRCA1/2 patients were identified. Average patient age was 56.8 years, 88.3% were women, and 51.5% had BRCA1 . The prevalence of low-risk pancreatic lesions was 14.4%, intermediate-risk 13.9%, and high-risk 3.3%. The prevalence of BD-IPMN was 13.6% with mean cyst size 7.7 mm (range: 2 to 34 mm). The prevalence of pancreatic cancer was 3.1%. Subsequent imaging was performed in 169 patents with mean follow-up interval of 5.3 years (range: 0 to 19.7 y). The incidence of BD-IPMN was 20.1%, with median cyst size 5.5 mm (range: 2 to 30 mm). The incidence of pancreatic cancer was 2.9%. BRCA2 patients were almost 4-times more likely to develop pancreatic cancer than BRCA1 patients, however, there was no difference in incidence or prevalence of BD-IPMN. CONCLUSIONS: Incidence and prevalence of BD-IPMNs in BRCA1/2 patients was similar to that reported for average-risk individuals. BRCA2 patients were more likely than BRCA1 patients to develop pancreatic cancer but had similar rates of BD-IPMN.

The incremental yield of adenoma detection with I-Scan versus high-definition white light colonoscopy-a systematic review and meta-analysis of randomized studies.

INTRODUCTION: The incremental yield of I-Scan virtual chromoendoscopy compared to high-definition white light endoscopy (HD-WLE) in detection of colorectal adenomas has not been thoroughly elucidated. METHODS: A systematic search from inception to April 2023 was conducted to identify randomized controlled trials (RCTs) comparing I-Scan to HD-WLE for detection of adenomas. A random effects model was used to compute risk difference (RD) with corresponding 95% confidence intervals in adenoma detection rate (ADR). Influence analysis was done to assess robustness of findings. The number needed to diagnose was computed. Heterogeneity was assessed using the I2 statistic and explored further by subgroup analyses defined a priori. Certainty in effect estimates was assessed using the GRADE approach. RESULTS: We identified four studies (I-Scan n = 730, HD-WLE n = 765). I-Scan increased adenoma detection by 9% (risk difference (RD), 0.09; 0.04, 0.14; I2 02%; certainty, low). Influence analysis revealed that the gain in yield remained statistically significant with exclusion of all but one study. The number needed to capture one additional adenomatous polyp with I-Scan use was 11.2. I-Scan 1 use was associated with a statistically significant gain in ADR, whereas no significant difference in ADR was noted with I-Scan use on subgroup analysis. DISCUSSION: In conclusion, I-Scan increases the yield of adenoma detection by 9% compared to HD-WLE, with low certainty in the estimate of this effect. Data on the gain in yield of detecting large polyps, sessile serrated lesions, and on the impact of formally training endoscopists and trainees in I-Scan use and similar technology on adenoma detection rate are needed.

Endoscopic ultrasound with combined fine needle aspiration plus biopsy improves diagnostic yield in solid pancreatic masses.

GOALS: Our aim was to compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration (EUS-FNA) versus combined fine needle aspiration and fine needle biopsy (EUS-FNA + FNB) in the evaluation of solid pancreatic masses (SPMs). BACKGROUND: EUS-FNA and EUS-FNB are established methods to diagnose SPMs. No studies have evaluated the efficacy of combination of both (EUS-FNA + FNB). Our senior author (MRS) hypothesized that combining the two techniques by using a single FNB needle improves diagnostic yield and started combination technique in October 2016. STUDY: Patients who underwent EUS for SPMs by MRS during January 2014-September 2019 were included. They were divided into the EUS-FNA group and EUS-FNA + FNB group. EUS-FNA was performed using a 22 or 25 gauge Expect Slimline needle (Boston Scientific, Marlborough, MA) and EUS-FNA + FNB was performed using a single 22 or 25 gauge Shark-core needle (Medtronics, Minneapolis, MN, USA). Our primary outcome was to compare the diagnostic yield in the two groups. RESULTS: Among 105 patients included, 58 were in the EUS-FNA group and 47 were in the EUS-FNA + FNB group. EUS-FNA + FNB group had significantly higher diagnostic yield and required fewer needle passes compared to EUS-FNA group, 95.7% vs. 77.6%, p = .01: and 4 vs. 5, p = .002; respectively. Procedural duration was similar in both groups but the combined technique required less number of needles per procedure. There was no difference in adverse events in the two groups. CONCLUSION: Our study showed that combined EUS-FNA + FNB had higher diagnostic yield compared to EUS-FNA in SPMs along with less number of needle passes and needles required. Further prospective studies are needed to validate these findings and cost-effectiveness of this strategy.

Confidentiality and Conflicts of Interest: An Assessment of Twitter Posts in Gastrointestinal Endoscopy.

INTRODUCTION: To evaluate compliance with confidentiality and conflicts of interest (COI) in tweets sharing gastrointestinal (GI) endoscopy videos/images. METHODS: Physicians' tweets containing GI endoscopy videos/images were assessed for confidentiality and COI compliance. RESULTS: Identifiable details in tweets included procedure date (17.9%), date of birth (0.8%), and patient's face visible (0.5%). Ninety-five tweets (10%) mentioned the name/brand of a medical device. Of the 19 posted by US physicians, 7 came from physicians who had received payments from the device manufacturer. None of these physicians disclosed relevant COI. DISCUSSION: GI endoscopy tweets describing clinical cases or procedures may insufficiently address issues of confidentiality and COI.

Proposal of high-risk adenoma detection rate as an impactful, complementary quality indicator of colonoscopy.

BACKGROUND AND AIMS: Adenoma detection rate (ADR), a validated quality indicator (QI) of colonoscopy, does not take into account risk stratification of adenomas. Low-risk adenomas are not associated with a significantly increased risk of future colorectal cancer (CRC). On the other hand, high-risk adenomas (HRA) are associated with up to six fold higher risk of future CRC. Therefore, HRA detection rate (HR-ADR) as a QI in addition to ADR may further enhance the efficacy of screening colonoscopy. Our aim was to calculate ADR and HR-ADR in a large cohort of average risk screening colonoscopy patients and propose HR-ADR which correlates with current threshold ADR. METHODS: This is a retrospective chart review of all colonoscopies performed in patients aged ≥ 50 years at our institution between 2012 and 2014. Average risk patients who had complete colonoscopy with good, excellent and adequate bowel preparation were included. Overall and gender-specific ADR and HR-ADR were calculated. HR-ADR was defined as proportion of colonoscopies with HRA. RESULTS: Among 4158 colonoscopies included, ADR was 26.4 ± 10.9% overall, 32.7 ± 14.5% in men, and 22.1 ± 12.6% in women. HR-ADR was 8.0 ± 5.7% overall, 10.2 ± 8.6% in men, and 6.1 ± 6% in women. There was only moderate correlation between ADR and HR-ADR [r = 0.57 (0.40-0.70)]. HR-ADR corresponding with minimum threshold ADR of 30% in men and 20% in women were calculated to be 7% in men and 4% in women. CONCLUSIONS: HR-ADR correlates only moderately with ADR. Based on the current threshold ADRs, we propose a benchmark HR-ADR of 7% in men and 4% in women as complementary QI to ADR.

Hospital Utilization in Patients With Gastric Cancer and Factors Affecting In-Hospital Mortality, Length of Stay, and Costs.

INTRODUCTION: Although gastric cancer (GC) rates have been declining in the United States, it continues to be a major cause of morbidity. This study examined trends in hospital admissions, in-hospital mortality, length of stay (LOS), and inpatient costs related to GC. In addition, various factors associated with in-hospital mortality, LOS, and inpatient costs were examined. METHODS: National inpatient sample-the largest publicly available all-payer inpatient care database-was interrogated to obtain information about various demographic and hospital-related factors (including those mentioned above) in patients who were primarily admitted for GC between the years 1998 to 2013. These trends were analyzed. Multivariate analysis was also performed to identify risk factors associated with LOS, costs, and mortality. RESULTS: A total of 679,330 hospital discharges with the principal diagnosis of GC were obtained. Hospital stays increased by approximately 340 stays per year (±110; P=0.00079). However, inpatient mortality rate and LOS declined by 0.36% per year (±0.024%; P<0.0001), and 0.11 days per year (±0.01; P<0.0001), respectively. The inpatient charges have increased at the rate of $3241 per year (±133.3; P<0.0001). Differences in mortality rate, LOS, and inpatient costs were affected by multiple factors. CONCLUSIONS: Despite the overall decline in GC incidence, the incidence of hospitalizations per 100,000 US population related to GC did not change significantly. Although LOS and mortality declined, inpatient charges increased over the study period.

Monitoring standards in sedation and analgesia: the odyssey of capnography in sedation for gastroenterology procedures.

PURPOSE OF REVIEW: Capnography is an excellent tool for early detection of hypoxemia and apnea in patients undergoing sedation for gastrointestinal endoscopy. The current American Society of Anesthesiology (ASA) guidelines recommend the use of capnography in any patient undergoing moderate sedation. The purpose of this review was to compile the most recent data available on capnography use in gastrointestinal endoscopy with the focus primarily on the use of capnography in moderate sedation cases. RECENT FINDINGS: Recent high-quality studies have evaluated the utility of capnography in low risk patients undergoing moderate sedation and have found no benefit with addition of capnography. SUMMARY: Capnography is beneficial when used for patients who are at a higher risk for sedation-related complications. There is no benefit when capnography is used in low risk patients undergoing routine upper endoscopy and colonoscopy under moderate sedation but there is benefit when used in advanced endoscopic procedures that require deeper sedation and have longer procedure times.

Outcomes Associated With Timing of ERCP in Acute Cholangitis Secondary to Choledocholithiasis.

GOALS: To determine the outcomes associated with timing of endoscopic retrograde cholangiopancreatography (ERCP) in patients with acute cholangitis due to choledocholithiasis, from a population-based study. BACKGROUND: Although ERCP is the cornerstone in the management of patients with acute cholangitis due to choledocholithiasis, the effect of timing of ERCP on health care outcomes is not well known. MATERIALS AND METHODS: In this retrospective study, national inpatient sample (NIS) data were used to identify patients with a combined primary or secondary diagnosis of cholangitis and choledocholithiasis from 1998 to 2012. Patients were divided into 4 groups based on timing of ERCP after admission: (1) ERCP performed within 24 hours (urgent ERCP); (2) ERCP performed between 24 and 48 hours (early ERCP); (3) ERCP performed after 48 hours (delayed ERCP); and (4) no ERCP performed. Main outcomes measured were length of stay (LOS), hospitalization charges, and in-hospital mortality. RESULTS: A total of 107,253 patients were identified of which 77,323 patients underwent ERCP at any point in time. Urgent ERCP group had shortest LOS, while delayed ERCP group had significantly longer LOS than all other groups (P<0.001). Delayed ERCP group had also the highest costs (P<0.001). In-hospital mortality was highest in no ERCP group, followed by delayed ERCP group (P<0.001); there was no difference in mortality between urgent ERCP and early ERCP. CONCLUSIONS: This study provides robust, population-based evidence that ERCP should not be delayed for >48 hours in patients with acute cholangitis due to choledocholithiasis.

Similar Risk of Cardiopulmonary Adverse Events Between Propofol and Traditional Anesthesia for Gastrointestinal Endoscopy: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Even though propofol use for gastrointestinal endoscopic procedures has increased over the past decade, there is a perception that it causes a higher rate of cardiopulmonary adverse events. The aim of this study was to compare the sedation-related adverse events associated with use of propofol vs nonpropofol agents for endoscopic procedures. We also wanted to determine the influence of duration or complexity of the procedures and endoscopist-directed (gastroenterologist) vs non-gastroenterologist-directed sedation on the outcomes. METHODS: A search was conducted using Medline, EMBASE, and the Cochrane controlled trials registry. The following cardiopulmonary adverse events were assessed: hypoxia, hypotension, and arrhythmias. The procedures were divided into 2 groups based on the procedure length: a nonadvanced endoscopic procedure group consisting of esophagogastroduodenoscopy, colonoscopy, and sigmoidoscopy, and an advanced endoscopic procedures group including endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, balloon enteroscopy, and endoscopic submucosal dissection. Pooled odds ratios for complications were calculated for all the procedures combined and then separately for the 2 groups. Random-effects models were used for 2-proportion comparisons. RESULTS: Of the 2117 citations identified, 27 original studies qualified for this meta-analysis and included 2518 patients. Of these, 1324 received propofol, and 1194 received midazolam, meperidine, pethidine, remifentanil, and/or fentanyl. Most of the included studies were randomized trials of moderate quality and nonsignificant heterogeneity (Cochran Q, 26.07; P = .13). Compared with traditional sedative agents, the pooled odds ratio with the use of propofol for developing hypoxia for all the procedures combined was 0.82 (95% confidence interval [CI], 0.63-1.07), and for developing hypotension was 0.92 (95% CI, 0.64-1.32). In the nonadvanced endoscopic procedure group, those who received propofol were 39% less likely to develop complications than those receiving traditional sedative agents (odds ratio, 0.61; 95% CI, 0.38-0.99). There was no difference in the complication rate for the advanced endoscopic procedure group (odds ratio, 0.86; 95% CI, 0.56-1.34). A subgroup analysis did not show any difference in adverse events when propofol was administered by gastroenterologists or nongastroenterologists. CONCLUSIONS: Propofol sedation has a similar risk of cardiopulmonary adverse events compared with traditional agents for gastrointestinal endoscopic procedures. Propofol use in simple endoscopic procedures was associated with a decreased number of complications. When used for gastrointestinal endoscopic procedures of a complex nature and longer duration, propofol was not associated with increased rates of hypoxemia, hypotension, or arrhythmias. Administration of propofol by gastroenterologists does not appear to increase the complication rates.

Inpatient burden of constipation in the United States: an analysis of national trends in the United States from 1997 to 2010.

OBJECTIVES: Constipation is one of the most common outpatient diagnoses in primary care and gastroenterology clinics; however, there is limited data on the inpatient burden of constipation in the United States. The aim of this study was to evaluate inpatient admission rates, length of stay, and associated costs related to constipation from 1997 to 2010. METHODS: We analyzed the National Inpatient Sample Database for all patients in which constipation (ICD-9 codes: 564.0-564.09) was the principal discharge diagnosis from 1997 to 2010. The statistical significance of the difference in the number of hospital discharges, length of stay, and hospital costs over the study period was determined by utilizing the Spearman's coefficient to describe various trends. RESULTS: Between 1997 and 2010, the number of hospitalizations for patients with a primary discharge diagnosis of constipation increased from 21,190 patients to 48,450 (P<0.001, GoF test), whereas the mean length of hospital stay increased only slightly from 3.0 days to 3.1 days (b=0.008 (0.003-0.014); P=0.004). The mean charges per hospital discharge for constipation increased from $8869 in 1997 (adjusted for long-term inflation) to $17,518 in 2010 (b=745.4 (685.3-805.6); P<0.001)), whereas the total costs increased from $188,109,249 (adjusted for inflation) in 1997 to $851,713,263 in 2010. Although the elderly (65-84 years) accounted for the largest percentage of constipation discharges, patients in the 1-17 years age group had the highest frequency of constipation per 10,000 discharges. CONCLUSIONS: The number of inpatient discharges for constipation and associated costs has significantly increased between 1997 and 2010.

Propofol versus traditional sedative agents for advanced endoscopic procedures: a meta-analysis.

BACKGROUND AND AIM: The optimum method for sedation for advanced endoscopic procedures is not known. Propofol deep sedation has a faster recovery time than traditional sedative agents, but may be associated with increased complication rates. The aim of the present study was to pool data from all available studies to systematically compare the efficacy and safety of propofol with traditional sedative agents for advanced endoscopic procedures. METHODS: Databases including PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials updated as of January 2013 were searched. Main outcome measures were procedure duration, recovery time, incidence of complications (hypotension, hypoxia), sedation level, patient cooperation and amnesia during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, and deep small bowel enteroscopy. RESULTS: Nine prospective randomized trials with a total of 969 patients (485 propofol, 484 conscious sedation) were included in the meta-analysis. Pooled mean difference in procedure duration between propofol and traditional sedative agents was -2.3 min [95% CI: -6.36 to 1.76, P = 0.27], showing no significant difference in procedure duration between the two groups. Pooled mean difference in recovery time was -30.26 min [95% CI: -46.72 to -13.80, P < 0.01], showing significantly decreased recovery time with propofol. There was also no significant difference between the two groups with regard to hypoxia and hypotension. CONCLUSIONS: Propofol for advanced endoscopic procedures is associated with shorter recovery time, better sedation and amnesia level without an increased risk of cardiopulmonary complications. Overall patient cooperation was also improved with propofol sedation.

Prospective assessment of the accuracy of ASGE and ESGE guidelines for choledocholithiasis.

Background and study aims American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend categorizing patients by risk for choledocholithiasis to determine management. The goal of our study was to compare the accuracy of criteria proposed in these guidelines. Patients and methods All patients with suspected choledocholithiasis at our institution were prospectively identified. Based upon initial test results, patients were categorized as low, intermediate, and high risk for choledocholithiasis per ASGE 2010 and 2019, and ESGE criteria. Patients were followed until 30 days post-discharge. Results of endoscopic retrograde cholangiography (ERCP), endoscopic ultrasound, and magnetic resonance cholangiopancreatography were used as criteria standard for choledocholithiasis. The accuracy of each criterion for choledocholithiasis was computed. Results During the study period, 359 consecutive patients with suspected choledocholithiasis were identified, of whom 225 had choledocholithiasis. Median patient age was 69 years and 55.3% were women. ESGE criteria categorized 47.9% as high-risk, lower than ASGE 2010 (62.7%, P <0.01), and 2019 criteria (54.6%, P =0.07). In high-risk patients, choledocholithiasis was noted in 83.1% for ESGE criteria, similar for ASGE 2019 (81.6%, P =0.7) and 2010 criteria (79.1%, P =0.3). The percentage of patients who underwent unnecessary ERCP was 8.1% per ESGE criteria, lower than ASGE 2010 (13.1%, P =0.03), but similar to 2019 criteria (10%, P =0.4). No difference in accuracy for choledocholithiasis was noted among the three criteria. No 30-day readmissions for choledocholithiasis were noted in the low-risk category. Conclusions ESGE and ASGE guidelines have similar accuracy for diagnosis of choledocholithiasis. However, ESGE criteria result in more patients needing additional testing, but also a smaller proportion of patients undergoing unnecessary ERCP.

Endoscopic retrograde cholangiopancreatography-related early perforations: A study of effects of procedure duration, complexity, and endoscopist experience.

BACKGROUND: Perforations (Perf) during endoscopic retrograde cholangiopancreatography (ERCP) are rare (< 1%) but potentially fatal events (up to 20% mortality). Given its rarity, most data is through case series studies from centers or analysis of large databases. Although a meta-analysis has shown fewer adverse events as a composite (bleeding, pancreatitis, Perf) during ERCP performed at high-volume centers, there is very little real-world data on endoscopist and center procedural volumes, ERCP duration and complexity on the occurrence of Perf. AIM: To study the profile of Perf related to ERCP by center and endoscopist procedure volume, ERCP time, and complexity from a national endoscopic repository. METHODS: Patients from clinical outcomes research initiative-national endoscopic database (2000-2012) who underwent ERCP were stratified based on the endoscopist and center volume (quartiles), and total procedure duration and complexity grade of the ERCP based on procedure details. The effects of these variables on the Perf that occurred were studied. Continuous variables were compared between Perf and no perforations (NoPerf) using the Mann-Whitney U test as the data demonstrated significant skewness and kurtosis. RESULTS: A total of 14153 ERCPs were performed by 258 endoscopists, with 20 reported Perf (0.14%) among 16 endoscopists. Mean patient age in years 61.6 ± 14.8 vs 58.1 ± 18.8 (Perf vs. NoPerf, P = NS). The cannulation rate was 100% and 91.5% for Perf and NoPerf groups, respectively. 13/20 (65%) of endoscopists were high-volume performers in the 4th quartile, and 11/20 (55%) of Perf occurred in centers with the highest volumes (4th quartile). Total procedure duration in minutes was 60.1 ± 29.9 vs 40.33 ± 23.5 (Perf vs NoPerf, P < 0.001). Fluoroscopy duration in minutes was 3.3 ± 2.3 vs 3.3 ± 2.6 (Perf vs NoPerf P = NS). 50% of the procedures were complex and greater than grade 1 difficulty. 3/20 (15%) patients had prior biliary surgery. 13/20 (65%) had sphincterotomies performed with stent insertion. Peritonitis occurred in only 1/20 (0.5%). CONCLUSION: Overall adverse events as a composite during ERCP are known to occur at a lower rate with higher volume endoscopists and centers. However, Perf studied from the national database show prolonged and more complex procedures performed by high-volume endoscopists at high-volume centers contribute to Perf.

Potential clinical complications of Orise™ gel use, a new submucosal lifting agent: experience from a tertiary care center and review of the literature.

Background: Endoscopic mucosal resection (EMR) involves forming a fluid cushion in the submucosal area with a lifting agent, followed by superficial resection. Orise™ gel is one of the commonly used lifting agents for EMR. We present a case series and literature review that analyzes the characteristic histopathological findings and clinical implications observed where Orise™ gel was used before EMR. Methods: Colon resection specimens and prior EMR specimens where Orise™ gel was used were reviewed for patients undergoing EMR between January 2018 and December 2020. The literature review included relevant studies from the Medline and Cochrane databases from January 2018 to December 2020. Results: A total of 12 colon polyp EMRs using Orise gel were performed during the study period. Seven patients (58.34%) underwent surgical resection. Histological examination revealed that, after the EMR procedure, the Orise™ gel material changed its morphological characteristics over time from a basophilic (bluish) non-inflamed pattern to an eosinophilic (pink) type pattern, eliciting a foreign body reaction. The endoscopic appearance and examination of the excised specimens weeks after injection gave the impression of a mass in some cases. The material was also present transmurally and in some cases in the peri-intestinal adipose tissue. Conclusions: It was observed that Orise™ gel use elicits a foreign body-type granulomatous reaction. This potential side effect may lead to overdiagnosis of a mass/lesion and unnecessary surgical interventions. This case series and review of the literature aims to increase awareness of the changes caused by Orise™ gel in the gastrointestinal tract.