Open Primary Button Versus Laparoscopic Percutaneous Endoscopic Gastrostomy: Results From a Case-control Study.

OBJECTIVES: Open primary balloon gastrostomy (PBG) presents a potential alternative to percutaneous endoscopic gastrostomy (PEG) in children as it obviates the need for change under general anaesthetic; however, the complication profile of PBG compared to PEG is not well defined. Previous series comparing the two have been hampered by the groups not being equivalent. Our paediatric surgical centre has offered PBG as an alternative PEG since 2014. We used a matched case-control study to compare outcomes for PBG and PEG. METHODS: Patients undergoing PBG were used as "cases" and matched 1:3 by age and diagnosis to patients undergoing PEG, demographics, and clinical data as "controls." Primary outcome was rate of complications classified according to Clavien-Dindo (I-V). Secondary outcomes included time to feed and length of stay. Non-parametric, categorical and multivariate logistic regression analyses were performed. Data here presented as median with interquartile range (IQR). RESULTS: We included 140 patients (35 PBG:105 PEG). The 2 groups were comparable for sex, weight at surgery, and follow-up duration. Median operative time was longer for PBG (43 min [IQR 36.5-61.5] vs 27.5 min [18.25-47.75], P < 0.001). Multivariate analysis demonstrated a statistically significant, higher incidence of symptomatic granulation tissue in PBG (10 [29%] vs 6 [6%], P = 0.0008), this remained significant on multivariate analysis (OR 7.56 [2.33-23.5], P = 0.001), no other complication remained significant. The overall complication rate was not statistically different. CONCLUSIONS: PBG and PEG have similar overall complication rates; however, PBG appears to have a higher incidence of granulation tissue. This observation must be weighed against the need for further general anaesthetic which is not insignificant in medically complex children

Pediatric Esophageal Dilatations: A Cross-Specialty Experience

AIM OF THE STUDY: Esophageal dilatations are commonly performed in pediatric patients who have undergone an esophageal atresia/tracheoesophageal fistula (EA/TEF) repair or following caustic injury. We sought to compare the practice of esophageal dilatation across different specialties. METHODS: We analyzed all patients who had an esophageal dilatation at our center between April 2014 and December 2018. Patients were identified via prospectively maintained databases and clinical coding records. Patients had a combination of dilatations under each specialty: interventional radiology (IR), surgery, and gastroenterology. RESULTS: Thirty-five individual patients underwent 226 dilatations, median dilatations per patient was 3 (1–40). The median age at first dilatation was 18 months (1–194 months). Sixty-eight percent of patients had a previous EA/TEF repair. IR performed 59% of dilatations, surgeons 26%, and 15% by gastroenterologists. Surgeons more frequently were performing initial dilatations (P < .05) and performed more dilatations in EA/TEF patients (P < .0001). There was a significant difference between the time from a surgical dilatation until the next dilatation, 3.7 months, compared with an IR dilatation, 1.8 months (ANOVA, P < .05). Surgeons more frequently increased the size of balloon used (57% versus 33% versus 39%, P < .01). There was no significant difference in balloon size between specialties or in the incremental increase in size between subsequent dilatations. There was one postprocedure perforation, managed conservatively (complication rate = 0.4%). CONCLUSIONS: We have demonstrated that on average, patients wait longer after a surgical dilatation until their next procedure, and surgical teams are more likely to increase the size of the dilating balloon. Surgeons tend to be more involved in their postoperative patients in the initial phases of stricture management. Our results suggest the feasibility and safety of a multispecialty approach for these patients

HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer

BACKGROUND: Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a particularly aggressive form of the disease, and ultimately progresses in patients with metastases on standard therapies. Anthracyclines, such as doxorubicin, are an effective treatment for HER2-positive breast cancer, particularly when administered in combination with trastuzumab – however, doxorubicin-related cardiotoxicity has limited its use. Many patients are therefore never treated with anthracyclines, even upon disease progression, despite the potential for benefit. MM-302 is a novel, HER2-targeted antibody–liposomal doxorubicin conjugate that specifically targets HER2­overexpressing cells. Preclinical and Phase 1 data suggest that MM-302, as a monotherapy or in combination with trastuzumab, could be effective for managing previously treated, anthracycline-naïve, HER2-positive breast cancer, without the cardiotoxicity observed with free doxorubicin formulations. METHODS/DESIGN: HERMIONE is an open-label, multicenter, randomized (1:1) Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice (gemcitabine, capecitabine, or vinorelbine) plus trastuzumab planned to enroll 250 anthracycline-naïve patients with locally advanced/metastatic HER2-positive breast cancer. Key inclusion criteria are: previous treatment with trastuzumab (with or without pertuzumab) in any setting; refractory or intolerant to pertuzumab (refractory to pertuzumab defined as progression in the locally advanced or metastatic setting, or disease recurrence during or within 12 months of completing pertuzumab-containing neoadjuvant and/or adjuvant therapy); and disease progression on, or intolerant to, ado-trastuzumab emtansine for locally advanced or metastatic disease. The trial is currently being conducted at sites in the USA, Canada, and Western Europe. Treatment will be administered in 21-day cycles, and will be continued until disease progression or unacceptable toxicity. The primary endpoint is independently assessed progression-free survival (PFS). Tumor response will be assessed every 6 weeks, and defined according to RECIST v1.1. Secondary endpoints include investigator-assessed PFS, overall survival (OS), OS rates at 6 months and 1 year, objective response rates, safety and tolerability, quality of life, and the pharmacokinetic profile of MM-302 plus trastuzumab. DISCUSSION: The HERMIONE study will evaluate the efficacy and safety of MM-302 plus trastuzumab in patients with refractory HER2-positive advanced/metastatic breast cancer for whom there are no standard of care therapies with a proven survival advantage. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02213744. Registration date: 06AUG2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2385-z) contains supplementary material, which is available to authorized users

Surgical fires, a clear and present danger.

BACKGROUND: A surgical fire is potentially devastating for a patient. Fire has been recognised as a potential complication of surgery for many years. Surgical fires continue to happen with alarming frequency. We present a review of the literature and an examination of possible solutions to this problem. METHODS: The PubMed and Medline databases from 1948 onwards were searched using the subject headings "operating rooms", "fire", "safety" and "safety management". "Surgical fire" was also searched as a keyword. Relevant references from articles were obtained. RESULTS: Fire occurs when the three elements of the fire triad, fuel, oxidiser and ignition coincide. Surgical fires are unusual in the absence of an oxygen-enriched atmosphere. The ignition source is most commonly diathermy but lasers carry a relatively greater risk. The majority of fires occur during head and neck surgery. This is due to the presence of oxygen and the extensive use of lasers. The risk of fire can be reduced with an awareness of the risk and good communication. CONCLUSIONS: Surgery will always carry a risk of fire. Reducing this risk requires a concerted effort from all team members