Outcomes of underwater endoscopic mucosal resection for colorectal polyps-Insights from western India.

INTRODUCTION: Underwater endoscopic mucosal resection (uEMR) represents an alternative to conventional EMR for resection of sessile colorectal polyps. We aimed at assessing the efficacy and safety of uEMR for sessile colorectal polyps. METHODS: A retrospective analysis of endoscopy database was done for patients who underwent uEMR for sessile colorectal polyps more than 10 mm in size without any features of sub-mucosal invasion from two tertiary care centres in western India between January 2021 and June 2023. Exclusion criteria were other modes of endoscopic resection. Primary outcome was rate of en bloc resection. Secondary outcomes were complete resection rate, adverse events and recurrence rate. RESULTS: During the study period, 159 patients with 261 lesions met the study inclusion. Mean lesion size was 1.935 ± 0.71 cm with most lesion located in the rectum (75, 28.73%) followed by sigmoid colon (69, 26.43%). Most lesions had a Paris 0-Is morphology (192, 73.56%). Japan NBI Expert Team (JNET) IIa pattern was seen on narrow band imaging (NBI) in 221 (84.67%) lesions. Complete resection was achieved in 98.46% lesions (257/261). En bloc resection was achieved in 91.82% (236/257) lesions. Complications were seen in 6.8%, all of which were managed endoscopically. Recurrence was seen in 3.1% of polyps on follow-up. CONCLUSION: uEMR is a safe and efficacious technique for endoscopic resection for sessile colorectal polyps with high rates of en bloc resection for polyps more than 10 mm size.

Tata Memorial Centre Evidence Based Management of Colorectal cancer.

ABSTRACT: This review article examines the evidence-based management of colorectal cancers, focusing on topics characterized by ongoing debates and evolving evidence. To contribute to the scientific discourse, we intentionally exclude subjects with established guidelines, concentrating instead on areas where the current understanding is dynamic. Our analysis encompasses a thorough exploration of critical themes, including the evidence surrounding complete mesocolic excision and D3 lymphadenectomy in colon cancers. Additionally, we delve into the evolving landscape of perioperative chemotherapy in both colon and rectal cancers, considering its nuanced role in the context of contemporary treatment strategies. Advancements in surgical techniques are a pivotal aspect of our discussion, with an emphasis on the utilization of minimally invasive approaches such as laparoscopy and robotic surgery in both colon and rectal cancers, including advanced rectal cases. Moving beyond conventional radical procedures, we scrutinize the feasibility and implications of endoscopic resections for small tumors, explore the paradigm of organ preservation in locally advanced rectal cancers, and assess the utility of total neoadjuvant therapy in the current treatment landscape. Our final segment reviews pivotal trials that have significantly influenced the management of colorectal liver and peritoneal metastasis.

IgG4-related disorders of the gastrointestinal tract: Experience from a tertiary care centre with systematic review of Indian literature.

INTRODUCTION: IgG4-related disease (IgG4-RD) is a rare disease entity in India. We aimed at studying the clinical profile of IgG4-RD of gastrointestinal tract (GIT) from our centre, while systematically reviewing data from India. METHODS: Retrospective review of IgG4-RD of GIT was done using electronic medical records between January 2013 and July 2022. Literature search was done for studies of IgG4-RD of the GIT reported from India from 2000 till January 2023. Case series, case reports of IgG4-RD of GIT and case reports describing GIT with multi-organ involvement were included in the review. Primary outcome measure was response to treatment. Secondary outcome measure was relapse after remission. RESULTS: Thirty-one patients were included with 71% (22/31) having autoimmune pancreatitis. The diagnosis was achieved on surgical specimen in 35% (11/31) patients. Steroid was given to 64% (20/31) patients with remission achieved in 70% (14/20) patients. Four patients exhibitted response to prolonged course of steroids with maintenance azathioprine. Relapse was seen in four (20%) patients who achieved remission. Of 731 articles screened, 48 studies (four case series and 44 case reports) were included in the literature review. Of 95 patients described, steroids were given to 65.2% (62/95), while surgery was done in 33.6% (32/95). Remission was seen in 96.6% (85/88) with relapse occurring in 11.4% (10/88) patients on follow-up. CONCLUSION: One-third patients of IgG4-RD of GIT are diagnosed after surgery. Response to steroids is good with relapse occurring in up to 12% patients.

Short and long outcomes of endoscopic bilateral metal stent placement for malignant hilar biliary obstruction: Tertiary care oncology centre experience.

INTRODUCTION: Placement of biliary self-expanding metal stents (SEMS) has been effective for palliation of unresectable hilar malignant biliary obstruction. Optimal drainage in hilar obstruction may require placement of multiple stents. Data on multiple SEMS placement in hilar obstruction from India is sparse. METHODS: Retrospective review of patients with unresectable malignant hilar obstruction who underwent endoscopic bilateral SEMS insertion from 2017 to 2021 was done. Demographic details, technical success and functional success (decrease in the bilirubin value below 3 mg/dL at four weeks), immediate complications with 30-days mortality, requirement of re-intervention, stent patency and overall survival were studied. RESULTS: Forty-three patients were included (mean age 54.9 years, 51.2% females). Thirty-six patients (83.7%) had carcinoma gallbladder as primary malignancy. Twenty-six patients (60.5%) were metastatic at presentation. Cholangitis was seen in 4/43 (9.3%). On cholangiogram, 26 (60.4%) had Bismuth type II block, 12 (27.8%) had type IIIA/B, 5 (11.6%) had type IV block. Technical success was achieved in 41/43 (95.3%) patients (38, side-by-side SEMS placement; 3, SEMS-within-SEMS in Y fashion). Functional success was achieved in 39 patients (95.1%). No moderate-severe complications were reported. Median post-procedure hospitalization was five days. Median stent patency was 137 days (interquartile range [IQR] 80-214 days). Re-intervention was required in four patients (9.3%) after mean 295.7 days. Median overall survival was 153 days (IQR 108-234 days). CONCLUSION: Endoscopic bilateral SEMS in complex malignant hilar obstruction has good outcomes in the form of technical success, functional success and stent patency. Survival is dismal despite optimal biliary drainage.

Rapid on-site evaluation (ROSE) versus macroscopic on-site evaluation (MOSE) for endoscopic ultrasound-guided sampling of solid pancreatic lesions: a paired comparative analysis using newer-generation fine needle biopsy needles.

Background: Rapid on-site examination (ROSE) during endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has been a subject of debate. We compared the yield of EUS-FNB with adequacy assessed using macroscopic on-site evaluation (MOSE), and smear cytology with adequacy confirmed by ROSE, acquired using the same needle. Methods: Consecutive patients with solid pancreatic lesions (SPLs) who underwent EUS-FNB of pancreatic solid lesions between January 2021 and July 2022 were included. Demographic details, site and size of lesion, number of passes, and the diagnosis by cytology and histopathology of core tissue were noted. The first pass was used for ROSE adequacy assessment and was subsequently sent for cytological assessment. Additional passes were taken subsequently to acquire core tissue. Adequacy was confirmed by MOSE (whitish core of more than 4 mm). Final cytology and histopathology (HPE) were compared for diagnostic accuracy. Results: One hundred fifty-five patients were included in the analysis during the study period (mean age 55.1+12.9 years; 60% male; 77% in pancreatic head; median size 3.7 cm). The final diagnosis was malignancy in 129, while 26 were negative for malignancy. Sensitivity and specificity for ROSE with cytology in detecting malignant SPLs were 96.9% and 100%, respectively. HPE with MOSE had sensitivity and specificity of 96.1% and 100%, respectively. A comparison of diagnostic accuracy showed no significant difference (P>0.99) between HPE with MOSE and ROSE with cytology, using an FNB needle. Conclusion: MOSE is as good as ROSE in terms of diagnostic yield for solid pancreatic lesions sampled using newer-generation EUS biopsy needles.

Endoscopic Ultrasound-Guided Antegrade Stent Placement in Patients with Failed ERCP as a Modality of Preoperative and Palliative Biliary Drainage.

BACKGROUND: No large studies have addressed the role of endoscopic-ultrasound biliary drainage (EUS-BD) as preoperative biliary drainage (PBD) for malignant extrahepatic biliary obstruction (MEBO). We aimed to discuss the outcomes of EUS antegrade stent placement (EUS-AG) in the preoperative and palliative setting. METHODS: Retrospective review of patients who underwent EUS-AG for MEBO between December 2019 and December 2021 was done. Primary outcome measures were technical success and clinical success. Secondary outcome measures were number of days of hospitalization postprocedure, adverse events related to EUS-AG procedure, morbidity related to surgery, and 3-month mortality after surgery. RESULTS: 54 patients underwent attempt for EUS-AG (mean age 54.8 ± 12.1 years; female 44.4%). Most common primary cancer was pancreatic cancer in 42.1% (23/54) patients. Indication was palliative in 34 (62.9%) patients and PBD in 20 (37%) patients. Level of block was distal in 35 (64.8%) and proximal in 19 (35.1%) patients. Technical success of EUS-AG was 88.7% (47/53). Clinical success was seen in 95.7% (45/47) patients. Median number of days of hospitalization postprocedure was 1 day. No procedure-related severe adverse events were seen. Of 20 patients who underwent EUS-AG as PBD, 19 had technical success (95%) with clinical success in 94.5% (18/19). Surgery was performed in 11 patients, of whom 10 patients underwent successful PPPD (one intraoperative liver metastasis). Two patients had Clavein-Dindo III/IV complication post-PPPD, with one mortality within 30 days of surgery. CONCLUSION: EUS-AG is safe and effective after failed ERCP in both preoperative and palliative setting.

EUS-guided biliary drainage in patients with moderate-severe cholangitis is safe and effective: a multi-center experience.

BACKGROUND: Patients with moderate-severe cholangitis require urgent/early biliary drainage and failed endoscopic retrograde cholangiopancreatography (ERCP) warrants use of percutaneous drainage. While endoscopic ultrasound-guided biliary drainage (EUS-BD) has evolved as an effective salvage modality but its safety and efficacy data in moderate-severe cholangitis are limited. PATIENTS AND METHODS: All consecutive moderate-severe cholangitis patients, with failed/technically non-feasible ERCP requiring EUS-BD in two tertiary care centers were included. Baseline laboratory and demographic parameters were documented. Technical and clinical success were primary outcome measures. Additionally, effective biliary drainage, adverse events due to procedure, hospital stay, ICU stay, and mortality were noted. RESULTS: Of the 49 patients (23 male; 46.9%) presenting with moderate/severe cholangitis, 23 (46.9%) had severe cholangitis. The median Charleston comorbidity index was 7.0 (IQR 2.0). Majority had malignant disease (87.8%) and 25 (51.0%) had inaccessible papilla. Technical success was achieved in 48 cases (98.0%), while clinical success with improvement of cholangitis was noted in 44 of 48 cases (91.7%). Effective biliary drainage was noted in 85.4% (41/48) cases. Adverse events in the form of mostly bleeding and bile leak were noted in 5 cases (10.2%) but managed conservatively. Distal obstruction exhibited significantly better clinical success (100% vs. 78.9%; p = 0.02) than hilar obstruction. Severe cholangitis had significantly lower clinical success (81.8% vs. 100%; p = 0.04) than moderate cholangitis. CONCLUSION: EUS-BD can be a safe and effective alternative option for patients with moderate to severe cholangitis, even with significant pre-morbid conditions, with acceptable adverse events rate.

Corrigendum to "Correlation of Clinicopathological Profile, Prognostic Factors, and Survival Outcomes with Baseline Alfa-Fetoprotein Levels in Patients with Hepatocellular Carcinoma: A Biomarker that is Bruised but Not Broken" [J Clin Exp Hepatol 12 (2022) 841-852].

[This corrects the article DOI: 10.1016/j.jceh.2021.11.006.].

Correlation of Clinicopathological Profile, Prognostic Factors, and Survival Outcomes with Baseline Alfa-Fetoprotein Levels in Patients With Hepatocellular Carcinoma: A Biomarker that is Bruised but Not Broken.

Background and aims: The role of Alfa-fetoprotein (AFP) in the management of hepatocellular carcinoma (HCC) is still debated, with differences in recommendations between international guidelines. We analyzed the relationship of the clinicopathological profile, prognostic features, and survival outcomes with baseline serum AFP levels in patients with HCC. Methods: Retrospective analysis of a prospectively accrued dataset of consecutive HCC patients was done. Results: 508 treatment naive patients were included in the analysis. AFP at presentation was normal (<10 ng/ml) in 18% patients. Patients with very high AFP (>400 ng/ml) had poor hepatic reserves (higher mean serum bilirubin, AST, ALT, INR, and lower mean albumin) and advanced disease at presentation (higher incidence of extrahepatic metastasis, and less proportion of patients with well-differentiated tumors). AFP >400 ng/ml was an independent predictor for presence of portal vein tumor thrombosis (PVTT) (OR, 4.08; 95% CI, 2.34-7.12; P < 0.001), higher tumor size (OR, 2.19; 95% CI, 1.36-3.54, P = 0.001) and advanced BCLC stage (OR, 4.19; 95% CI, 2.51-7.03; P < 0.001). Two-third of patients with small HCC (MTD <3 cm) and more than half with early-stage HCC (BCLC stage 0/A) had elevated AFP levels. No significant relationship was seen between overall survival (OS) and baseline AFP in patients who underwent surgery, but median OS in patients subjected to nonsurgical therapies was 19.4,10.5 and 5.7 months in patients having AFP <10 ng/ml, 10-400 ng/ml and >400 ng/ml respectively (P = 0.003). AFP >400 ng/ml was an independent predictor of survival in patients receiving any form of therapy (HR = 2.23; 95% CI = 1.19-4.18, P = 0.012). Conclusion: AFP as a biomarker still has a significant role to play in the management of HCC patients and is here to stay till the search for an ideal biomarker in HCC is over.

Technical and clinical success rates of WallFlex duodenal stents in unresectable malignant gastric outlet obstruction. A retrospective observational study from a tertiary cancer hospital in India.

Introduction: Gastric outlet obstruction (GOO) is one of the common symptoms/complications of many cancers. Endoscopic placement of a self-expandable metal stent has emerged as one of the best alternative treatment options for surgical gastrojejunostomy. Aim: We took up this study to find the technical and clinical success, and complication rates of duodenal stenting in such patients presented at India's largest tertiary care cancer hospital. Material and methods: This retrospective observational study included all patients who underwent endoscopic placement of an enteral WallFlex stent for malignant GOO between April 2013 and February 2019 at Tata Memorial Cancer Hospital, Mumbai, India. For estimation and improvement of symptoms, a GOO scoring system (GOOS) was used. The endpoints were defined as technical success, improvement of the GOO scoring system, and safety. Results: Technical and clinical success rates were 98.13% (210/214) and 91.42% (192/210), respectively. Complications included bleeding in 12 (5.60%), pancreatitis in 4 (1.86%), and sedation-related complications in 25 (11.68%) of the patients. In the mean follow-up period of 120 days (range: 90 to 270 days), recurrence of obstructive symptoms was observed in 66 (31.42%) of the patients. Tumour ingrowth in 59.09% (39/66), food impaction in 31.81% (21/66), and migration of the stent in 15.15% (10/66) of patients were reasons for recurrence. The median time between clinical success and recurrence of obstructive symptoms was 148 days (95% confidence interval (CI): 0-328). Conclusions: Placement of an enteral WallFlex stent in patients with malignant GOO is a practical, easy, and safe alternative to surgical gastrojejunostomy in malignant GOO.

A study of the clinical profile, predictors, prognostic features, and survival of patients with hepatocellular carcinoma having macroscopic portal vein tumor thrombosis.

BACKGROUND: Macroscopic portal vein tumor thrombosis (PVTT) is considered a negative prognostic factor in hepatocellular carcinoma (HCC) patients. There is divergent opinion regarding management of these patients worldwide. We aimed to evaluate the clinical profile, predictors, prognostic features, and survival of patients of HCC with PVTT. METHODS: Treatment-naïve HCC patients with and without PVTT were analyzed retrospectively using a prospectively accrued dataset. Patients with PVTT were further divided as per treatment groups for survival analysis. RESULTS: Of 508 patients, 46.1% had radiological evidence of PVTT at presentation. On logistic regression, serum albumin (odds ratio [OR]=0.65, 95% confidence interval [CI]= 0.44-0.96; p= 0.031); international normalized ratio (OR = 3.78,95% CI = 1.42-10.00; p=0.008); alpha-feto protein >400 ng/mL (OR=3.58, 95%CI = 2.00-6.40; p <0.001); size of largest tumor nodule >5 cm (OR =6.37, 95%CI =2.03-19.99; p =0.002); and male gender (OR =1.84, 95%CI = 1.01-3.33; p = 0.045) were independent predictors for PVTT. Patients with PVTT amenable to aggressive therapies had significantly better median overall survival (in months) as compared to those receiving sorafenib or best supportive care only (13.1, 3.9, and 1.8 respectively, p<0.0001). Treatment modality received (p<0.001) and extrahepatic metastasis (p=0.006) were independent predictors of mortality in these patients. CONCLUSION: Size of largest tumor nodule >5 cm and alpha-fetoprotein >400 ng/mL are strongly associated with the presence of PVTT in patients with HCC. A multidisciplinary approach may identify a subgroup of patients who can be offered aggressive therapies like surgery and/or locoregional therapy with significant survival benefit.

Hepatic tuberculosis masquerading as malignancy.

BACKGROUND AND AIMS: Hepatic tuberculosis (HTB) is rare and mimics neoplastic liver lesions clinico-radiologically leading to misdiagnosis and even unnecessary surgery. METHODS AND MATERIAL: We analysed 43 cases of HTB diagnosed at a referral cancer centre over 10 years. Clinical details, investigations and treatment received were noted. RESULTS: The median age was 46 years with a female preponderance (58%). HTB was diagnosed incidentally in 28% cases during surveillance imaging for a previous cancer. Constitutional symptoms (31, 72%), abdominal pain (25, 58%), fever (12, 28%), hepatomegaly (22, 51%), elevated alkaline phosphatase (34, 79%), elevated aminotransferases (18, 42%) and hypoalbuminemia (19, 45%) were common features. All cases had negative HIV serology and normal tumor markers. Twenty-two (52.5%) had solitary liver lesion and lesions > 2 cm in 28 (65%). Ultrasound showed hypoechoic lesions in 31 of 33 cases. Computed tomography showed hypodense lesions (43,100%) with mild peripheral enhancement (32, 74%). Calcifications (5, 12%) and capsular retraction (8, 19%) was uncommon. MRI was performed in seven cases commonly showed T1 hypointense, T2 hyperintense lesions with restricted diffusion. Histopathology showed granulomatous inflammation (42, 97.5%), Langhan's giant cells (41, 95%) and caseation necrosis (35, 85%). Acid-fast stain and PCR positivity was uncommon. Extrahepatic organs were involved in 20 (46.5%). HTB mimicked cholangiocarcinoma (25, 58%), liver metastasis (11, 26%) and lymphoma (3, 7%). Six patients underwent liver resection with a presumptive diagnosis of cancer without a preoperative biopsy. All patients received antitubercular therapy, 37 had clinico-radiological response, there were 3 deaths and 3 patients were lost to follow-up. CONCLUSION: HTB is rare and can mimic a malignancy clinico-radiologically. Calcifications and pseudocapsule appearance on multiphase CT scan may help in differentiating HTB from hepatic malignancy. Tumor markers are normal while histopathology is generally diagnostic. A high index of suspicion is required to avoid unnecessary surgery as the patients respond well to ATT. TRIAL REGISTRATION: This is a retrospective and observational study hence clinical trial registration is not applicable.

Predictors of toxicity after neoadjuvant chemoradiotherapy for locally advanced gall bladder cancer.

Background: The present study evaluated the correlation of hepatobiliary toxicity and radiation dose received in patients undergoing neoadjuvant chemoradiotherapy (NACRT) for locally advanced unresectable gall bladder cancers (LAGBC). Methods: Twenty-six patients with LAGBC, treated with NACRT (55-57 Gy/25 fractions/5 weeks and weekly gemcitabine 300 mg/m2) within a phase II study, were included. Whenever feasible, surgery was performed after NACRT. Acute and late hepatobiliary toxicity was recorded. Treatment scans were retrieved to delineate central porto-hepatobiliary system (CPHBS), resected liver surface, segment IV B and V, and duodenum. The doses received by these structures were recorded and correlated with toxicity. Results: Of 26 patients, 20 (77%) had partial or complete response and 12 (46%) had R0 resection. At the median follow-up of 38 months, overall survival was 38%. Eight (30%) patients had post-treatment toxicity, of which most common was biliary toxicity (30%). A correlation was observed between the biliary leak and V45Gy CPHBS >50 cm3 (P = 0.070). Higher toxicity was observed in those with metallic stents (P = 0.072). Conclusion: The incidence of the biliary leak was 46%. CPHBS dose was found to correlate with biliary leaks. Restricting V45Gy CPHBS <50 cm3 and using plastic stent may facilitate a reduction in hepatobiliary toxicity in patients undergoing NACRT and surgery.

Incremental value of endoscopic brush cytology in response assessment after chemo-irradiation for Esophageal cancer.

BACKGROUND: Response assessment after chemo-radiotherapy (CTRT) in locally advanced esophageal cancer is usually performed using a PET-CT scan, an upper GI endoscopy (UGIE) and histological correlation with biopsy or cytology. We aim to study the incremental value of brush cytology in addition to PET-CT for response assessment. MATERIALS AND METHODS: In this retrospective analysis, 40 patients with Stage II- IV carcinoma esophagus treated with radical intent between June 2015 and August 2019 were included. Patients were treated with either upfront concurrent CTRT or neo-adjuvant chemotherapy followed by CTRT. All patients underwent PET-CT and UGIE for initial staging and response assessment on follow-up. Patients with esophageal stricture (disease related or treatment induced) had brush cytology done during UGIE. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of brush cytology were calculated considering serial clinical follow-up as gold standard. RESULTS: Twenty-three male (57.5%) and 17 (42.5%) female patients with median age of 57 years (range: 27 - 79 years) were analyzed. Concurrent CTRT was delivered in 52.5%; 75% patients were treated with intensity-modulated radiotherapy (IMRT); median RT dose was 63 Gy (range- 41.4 to 64 Gy). At a median follow-up of 16 months (range 6- 54 months), 20 patients (55.5%) were clinically controlled, 9 (25%) had local recurrence, 5 (13.8%) had loco-regional recurrence and 2 had distant metastasis. Considering clinical follow-up as the gold standard, sensitivity, PPV and NPV of PET-CT combined with brush cytology improved compared to PET-CT alone and was found to be 75%, 90%, 85.7% and 81.8% respectively. CONCLUSION: We found that brush cytology on endoscopy is a simple tool with high specificity which adds value to the findings of response assessment PET-CT scan and thereby can increase the confidence of the treating oncologist in making clinical decisions.

Is Direct Laryngoscopy Obsolete? "Trans Nasal Oesophagoscopy" the Complete Endoscopic Solution in Head Neck Practice.

Direct laryngoscopy (DL) is the standard of care for the evaluation of suspicious lesions in the larynx and hypo pharynx but requires general anaesthesia and a dedicated operation theatre. While DL offers us the ability to map the lesion adequately and take a biopsy, it requires workup for anaesthesia well as rigid oesophagoscopy for assessing the oesophagus with its associated complications. Sixty-nine patients underwent TNE under topical anaesthesia. The lesions were mapped and biopsies taken. Those patients who had an inadequate evaluation on TNE or negative biopsy underwent direct laryngoscopy. Completeness of evaluation, adequacy of biopsy, presence of synchronous oesophageal lesions and the modified Gloucester Comfort Score for patient comfort was documented. Amongst 69 cases enrolled for TNE evaluation, 97% of cases had an adequate mapping of disease extent, and 100% adequacy of biopsy material. General anaesthesia could be avoided in 92.75% of patients. TNE took a median time of 8 min. Synchronous oesophageal tumours were seen in 5.8% of patients. There were no complications and 74% patients did not experience any discomfort. TNE appears to be simple, safe, efficient office based diagnostic procedure. TNE has the potential to be the new standard of care making DL obsolete.

Efficacy of ready-to-use therapeutic food in malnourished children with cancer: Results of a randomized, open-label phase 3 trial.

BACKGROUND: The adverse influence of undernutrition in children with cancer may be remediated by early nutritional intervention. This study assessed the efficacy of ready-to-use therapeutic food (RUTF) in improving nutritional status and reducing treatment-related toxicities (TRTs) in such children. METHODS: In a randomized controlled phase-3 open-label trial, severely and moderately undernourished children with cancer were randomized 1:1 to receive standard nutritional therapy (SNT) or SNT+RUTF for 6 weeks. The primary outcome (weight gain >10%) and secondary outcomes (improved/maintained nutritional status, improved body composition) were assessed after 6 weeks. TRTs were assessed over 6 months. RESULTS: Between July 2015 and March 2018, 260 subjects were enrolled, 126 were analyzable in both arms at 6 weeks. More children on RUTF had weight gain (98 [77.8%] vs. 81 [64.2%], p = .025) with a greater increase in fat mass as a percentage of body mass (median 2% [IQR -0.12 to 4.9] vs. 0.5% [IQR -1.45 to 2.27, p = .005]) but a greater loss of lean mass (median -1.86% [IQR -4.4 to 0.50] vs. -0.4% [IQR -2.4 to 1.4, p = .007]) compared to the SNT arm. Fewer subjects on the RUTF arm had episodes of severe infection (10.6% vs. 31%, p < .0001), treatment delays (17.7% vs. 39%, p < .0001), and severe mucositis (11% vs. 23.8%, p = .006) compared to the SNT arm. The odds of developing TRTs on the RUTF arm were lower even after adjusting for improvement in nutritional status. CONCLUSIONS: RUTF is efficacious in improving weight gain and nutritional status in undernourished children with cancer and decreases TRTs. Incorporating RUTF into a healthy, balanced diet should be considered in undernourished children with cancer.