Efficacy of the omental roll-up technique in pancreaticojejunostomy to prevent postoperative pancreatic fistula after pancreaticoduodenectomy.

Backgrounds/Aims: Pancreaticoduodenectomy (PD) is being performed more frequently. A pancreaticojejunostomy (PJ) leak is the major determinant of patient outcomes. An omental flap around PJ might improve postoperative outcomes. Methods: A prospective randomized controlled trial was planned at PGIMER, Chandigarh. Fifty-eight patients meeting the criteria were included in the study. Group A underwent PD with omental roll-up and group B underwent standard PD. Results: The mean age of patients in group A was 57.1 ± 14.3 years and 51.2 ± 10.7 in group B. Jaundice (p = 0.667), abdominal pain (p = 0.69), and co-morbidities were equal among the groups. The body mass index of patients in group B was higher at 24.3 ± 5.4 kg/m2 (p = 0.03). The common bile duct diameter (12.6 ± 5.3 mm vs. 17.2 ± 10.3 mm, p = 0.13) and the pancreatic duct diameter (4.06 ± 2.01 mm vs. 4.60 ± 2.43 mm, p = 0.91) were comparable. The intraoperative blood loss (mL) was significantly higher in group B (233.33 ± 9.57 vs. 343.33 ± 177.14, p = 0.04). Drain fluid amylase levels on postoperative day (POD) 1 (p = 0.97) and POD3 (p = 0.92) were comparable. The rate of postoperative pancreatic fistula (POPF) grade A (p ≥ 0.99) and grade B (p = 0.54) were comparable. The mean postoperative length of stay among was similar (p = 0.89). Conclusions: An omental wrap can be performed without increase in complexity of the procedure. However, its utility in preventing POPFs and morbidity remains unclear.

Preliminary results of hypofractionated radiotherapy in breast cancer in Chandigarh, India: single-centre, non-inferiority, open-label, randomised, phase 3 trial.

Background: Globally, most of the randomised trials with hypofractionation in patients with breast cancer have used 3-dimensional conformal radiotherapy technique (3D-CRT). As facilities for 3D-CRT technique may not be available in low-resource settings, there is a need to see if hypofractionation is feasible and safe with 2-dimensional (2-D) technique. In this study, we compared a 3-week radiation schedule with a 2-week schedule of hypofractionated radiotherapy in patients with breast cancer with 2-D technique. Methods: The current study was an open-label, randomised, phase 3 trial. Patients with breast cancer, stage I-III, post mastectomy or after breast conservative surgery who needed adjuvant locoregional radiotherapy were randomised in the Department of Radiotherapy & Oncology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India; to 34Gy in 10 fractions over 2 weeks (2-week arm) or 35Gy in 15 fractions over 3 weeks to the chest wall and 40Gy/15#/3wks to breast and supraclavicular fossa (3-week arm). Boost dose when indicated was 8-10Gy/2-4#/2-4 days in both the arms. Patients were planned on a 2-dimensional (2D) simulator with 2 tangential fields to breast/chest wall and incident supraclavicular fossa field. Acute toxicity was assessed using the Radiation Therapy Oncology Group (RTOG) grading scale. Assessments were carried out weekly during radiotherapy and at 4 weeks after treatment by the physician. Cosmetic outcome was assessed using the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/RTOG scale. The toxicity rates between the two arms were compared using Fisher's exact tests. The trial was approved by institutional ethics committee and registered with ClinicalTrials.gov, number NCT04075058. Findings: This study included 1121 eligible patients from June 2015 to December 2020. Median follow-up was 35 months (6-84 months). Mean age was 48 years (24-75 years). The patient characteristics were comparable between the two arms except for more mastectomies in the 3-week arm and more node-positive patients in the 2-week arm. There were more oestrogen receptor-positive tumors in the 3-week arm. Acute skin toxicities were comparable between the two arms. Grade 2 and 3 skin toxicity was 100 (18%) and 82 (15%); and 16 (3%) and 12 (2%) in the 3-week and 2-week arm (p = 0.21), respectively. Cosmetic outcome was assessed as Excellent or Good for 89% of patients in the 3-week arm as compared to 94% in the 2-week arm (p = 0.004). Interpretation: The two radiation schedules were comparable in terms of acute skin toxicity. The cosmetic outcome was better with the 2-week schedule. The preliminary findings indicate 2-week radiotherapy schedule with 2-D technique was better than the 3-week schedule in patients with breast cancer. However, disease outcomes and late-term toxicities need to be further checked. Funding: This study was funded by Science and Engineering Research Board (SERB), India.

Conventional vs Short Duration of Antibiotics in Patients With Moderate or Severe Cholangitis: Noninferiority Randomized Trial.

INTRODUCTION: Successful biliary drainage and antibiotics are the mainstays of therapy in management of patients with acute cholangitis. However, the duration of antibiotic therapy after successful biliary drainage has not been prospectively evaluated. We conducted a single-center, randomized, noninferiority trial to compare short duration of antibiotic therapy with conventional duration of antibiotic therapy in patients with moderate or severe cholangitis. METHODS: Consecutive patients were screened for the inclusion criteria and randomized into either conventional duration (CD) group (8 days) or short duration (SD) group (4 days) of antibiotic therapy. The primary outcome was clinical cure (absence of recurrence of cholangitis at day 30 and >50% reduction of bilirubin at day 15). Secondary outcomes were total days of antibiotic therapy and hospitalization within 30 days, antibiotic-related adverse events, and all-cause mortality at day 30. RESULTS: The study included 120 patients (the mean age was 55.85 ± 13.52 years, and 50% were male patients). Of them, 51.7% patients had malignant etiology and 76.7% patients had moderate cholangitis. Clinical cure was seen in 79.66% (95% confidence interval, 67.58%-88.12%) patients in the CD group and 77.97% (95% confidence interval, 65.74%-86.78%) patients in the SD group ( P = 0.822). On multivariate analysis, malignant etiology and hypotension at presentation were associated with lower clinical cure. Total duration of antibiotics required postintervention was lower in the SD group (8.58 ± 1.92 and 4.75 ± 2.32 days; P < 0.001). Duration of hospitalization and mortality were similar in both the groups. DISCUSSION: Short duration of antibiotics is noninferior to conventional duration in patients with moderate-to-severe cholangitis in terms of clinical cure, recurrence of cholangitis, and overall mortality.

Endoscopic ultrasound-guided drainage of early pancreatic necrotic collection: Single-center retrospective study.

BACKGROUND: Endoscopic ultrasound (EUS)-guided drainage is the standard of care for drainage of pancreatic necrosis. Though initially it was mainly used for drainage of only walled-off necrosis, recently, a few studies have also shown its safety in the management of acute necrotic collections. We did a retrospective study to evaluate the safety and efficacy of EUS-guided drainage in the early phase of pancreatitis as compared to interventions in the late phase. METHODS: We retrieved baseline disease-related, procedure-related and outcome-related details of patients who underwent EUS-guided drainage of pancreatic necrosis. Patients were divided into early (≤ 28 days from onset of pancreatitis) or delayed (> 28 days) drainage groups. Both groups were compared for disease-related characteristics and outcomes. RESULTS: Total 101 patients were included in the study. The mean age of included patients was 35.54 ± 13.58 years and 75 were male. Thirty-five patients (34.7%) underwent early drainage. In the early group, a majority of patients underwent intervention due to infected collection (88.6% vs. 18.2%; p < 0.001). More patients in the early group had < 30% wall formation (28.6% vs. 0%; p < 0.001) and > 30% solid debris within the collection (42.9% vs. 15.2%; p = 0.005). Patients in the early group were also more likely to require endoscopic necrosectomy (57.1% vs. 27.3%; p = 0.003) and additional percutaneous drainage (31.4% vs. 12.1%; p = 0.018). Overall, three patients in the early group and one patient in the delayed group had procedure-related complications. Four patients in the early group and one patient in the delayed group succumbed to illness (p = 0.029). CONCLUSION: Though delayed interventions remain standard of care in the management of acute pancreatitis, some patients may require early intervention due to infected collection with deteriorating clinical status. Early EUS-guided interventions in such carefully selected patients have in similar clinical outcomes and complication rates compared to delayed intervention. However, such patients are more likely to require additional endoscopic or percutaneous interventions.

Metabolic Syndrome in Breast Cancer Patients: An Observational Study.

BACKGROUND: The reported association between metabolic syndrome (MetS) and breast cancer may have a significant impact on the incidence and mortality related to breast cancer. We undertook this study to find if the disease is different in patients with MetS. MATERIALS AND METHODS: Patients with biopsy-proven breast cancer were divided into groups based on the presence or absence of MetS (according to the IDF definition of 2006) and also based on menopausal status. The presence of known risk and prognostic factors were also recorded, and the groups were compared. RESULTS: A total of 305 patients were recruited, of which 191 (62.6%) had MetS. Patients with MetS were older than those without (52.1 versus 48.3 years, P = .014) and had a lower incidence of nulliparity (4.1% vs 12.8%, P = .005) and dense breasts (2.9% in MetS vs 10.8% in no MetS, P = .009). On further dividing into premenopausal and postmenopausal, these differences persisted only in premenopausal patients. MetS group had a lower number of HER2-positive tumours (14.3% for MetS, 23.9% for no MetS; P = .036). After dividing into premenopausal and postmenopausal, significant differences were observed in distant metastases (5.4% in MetS vs 16.1% in no MetS, P = .045) and in grade (higher grade in MetS, P = .05) in premenopausal patients. In postmenopausal patients, difference was observed in HER2 positivity (12.3% in MetS vs 28.8% in no MetS, P = .008). CONCLUSIONS: Breast cancer in patients with MetS may not be significantly different from breast cancer in patients without MetS.