Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device.

INTRODUCTION: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. METHODS: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. RESULTS: 16 patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic Mucosal Resection (EMR) (6.3%), Endoscopic Submucosal Dissection ESD (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. In no case did rectal perforation or major complications requiring urgent reintervention occur. As for the level of reproducibility, safety, level of satisfaction with the device and evaluation of the blister, the evaluation on a scale of 0-10 (9.43, 9.71, 9.29 and 9.50 respectively). All the investigators have previous experience with transanal devices. CONCLUSIONS: The study demonstrates the efficacy and safety of UNI-VEC® for the treatment of rectal lesions. It will facilitate the implementation of hybrid procedures that seek to solve the limitations of pure endoscopic techniques by allowing the concomitant use of conventional laparoscopic and robotic instrumentation with the flexible endoscope.

Pharmacokinetic and clinical monitoring through posologic changes in adalimumab intensification regimen from 40 mg every week to 80 mg every other week.

BACKGROUND: Adalimumab dose escalation is often recommended for inflammatory bowel disease patients in cases of loss of response. The usual adalimumab intensification regimen was 40 mg every week. Recently the pharmaceutical companies commercialized the 80mg injection pen. In the biosimilars era, this pen was sold at the same price as the 40mg pen. Due to this and for patient comfort, we proposed that our stable intensified adalimumab patients on a 40mg every-week regimen, change to a dose of 80mg every-other-week. AIM AND METHODS: an observational study was performed to monitor outcome through this posologic change. Clinical, analytic parameters and adalimumab trough levels were prospectively obtained at baseline, 4 and 12 months after posologic change. The evolution of this cohort and calculates savings were described. RESULTS: 13 patients were included in the study and the median time of adalimumab intensification prior to posologic change to 80mg eow was 32 months (IQR 29-63). At 4 months, all patients maintained adalimumab 80mg every-other-week. After month 4, two patients returned to the previous regimen after mild worsening, without significant changes in CRP, calprotectin or adalimumab-trough-levels. At 1 year, adalimumab was stopped in one patient in remission with undetectable levels and positive adalimumab-antibodies. No significant differences in adalimumab-trough-levels were noted before and after the posologic change. Costs fell from 16276 €/patient/year of treatment to 8812.15 €/patient/year of treatment. CONCLUSION: In IBD patients with stable response to adalimumab intensification regimen of 40 mg every-week, changing to 80mg every-other-week seems to maintain response and similar adalimumab-trough-levels. Furthermore, it is cost-saving, although some patients may perceive mild symptoms.

ERCP and situs inversus.

An 85-year-old female with situs inversus totalis was admitted due to obstructive jaundice, secondary to multiple choledocholithiasis and distal biliary stenosis due to adenocarcinoma of the head of the pancreas, with duodenal infiltration and metastatic liver disease. An endoscopic retrograde cholangiopancreatography (ERCP) was attempted in the supine position but bile duct cannulation was not possible due to duodenal infiltration. Finally, a palliative biliary stent was placed percutaneously, with resolution of the jaundice.

Colonic diverticular bleeding: urgent colonoscopy without purging and endoscopic treatment with epinephrine and hemoclips.

Diverticular disease is the most frequent cause of lower gastrointestinal bleeding. Most of the times, bleeding stops without any intervention but in 10-20% of the cases it is necessary to treat the hemorrhage. Several modalities of endoscopic treatment have been described after purging the colon. We present five cases of severe diverticular bleeding treated with injection of epinephrine and hemoclips. All the colonoscopies were performed without purging of the colon in an emergency setting, with correct visualization of the point of bleeding. Patients recovered well avoiding other aggressive procedures such as angiography or surgery.

Diagnostic yield and clinical outcomes after capsule endoscopy in 100 consecutive patients with obscure gastrointestinal bleeding.

OBJECTIVES: The endoscopic capsule is a useful tool for visualizing the small bowel in patients with obscure gastrointestinal bleeding. In this study the authors evaluated the diagnostic aid provided by the endoscopic capsule, the factors predicting a significant finding and their impact on the patients' clinical evolution. METHODS: A total of 100 patients (52 men and 48 women, average age 64.4 years) underwent capsule endoscopy. Of this group, 52 patients presented with obscure-overt bleeding and 48 with obscure-occult bleeding. After an average follow-up time of 11.4 months, the clinical outcome was evaluated in 95 patients. RESULTS: The endoscopic capsule identified significant findings in 68% of patients. The most common diagnosis (33.8%) was angiodysplasias. The most important factor predicting significant findings was the previous need for transfusion in the overt bleeding group. As the result of the findings, a specific intervention was made in 75.8% of patients. At the end of follow-up, the clinical outcome was considered positive in 71.6% of patients. Capsule retention occurred in one patient, who required surgery. CONCLUSION: In patients with obscure gastrointestinal bleeding, capsule endoscopy provides a high degree of diagnostic aid. The best candidates for this procedure are patients with obscure-overt bleeding who have required blood transfusions. Capsule endoscopy has a positive influence on an important proportion of patients, whether oriented towards new diagnostic techniques or towards a definitive treatment.

Self-expandable stents in malignant colonic obstruction: insertion assisted with a sphincterotome in technically difficult cases.

BACKGROUND: Stent placement is effective in relieving malignant colonic obstruction. Nevertheless, the technique may offer difficulties in sharply angulated lesions. METHODS: Guidewire insertion assisted with a sphincterotome was performed in 4 patients with intestinal obstruction caused by malignant colonic strictures. The manipulation of the sphincterotome by turning and bending its tip allows the cannulation of the lesion with the guidewire and, as a consequence, the stent insertion. OBSERVATIONS: The procedure was successfully performed in 4 technically difficult cases in which it had been impossible to pass the guidewire with the standard catheter. CONCLUSIONS: In technically difficult cases, with the use of a sphincterotome, insertion of the guidewire appears to be easier. This new method may improve technical success rates in stent placement.