| 1. |
- Hedberg, Jakob, et al.
(författare)
-
Randomized controlled trial of nasogastric tube use after esophagectomy : study protocol for the kinetic trial
- 2024
-
Ingår i: Diseases of the esophagus. - : John Wiley & Sons. - 1120-8694 .- 1442-2050.
-
Tidskriftsartikel (refereegranskat)abstract
- Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.
|
|
| 2. |
- Lundquist, Patrik, et al.
(författare)
-
Barriers to the Intestinal Absorption of Four Insulin-Loaded Arginine-Rich Nanoparticles in Human and Rat
- 2022
-
Ingår i: ACS Nano. - : American Chemical Society (ACS). - 1936-0851 .- 1936-086X.
-
Tidskriftsartikel (refereegranskat)abstract
- Peptide drugs and biologics provide opportunities for treatments of many diseases. However, due to their poor stability and permeability in the gastrointestinal tract, the oral bioavailability of peptide drugs is negligible. Nanoparticle formulations have been proposed to circumvent these hurdles, but systemic exposure of orally administered peptide drugs has remained elusive. In this study, we investigated the absorption mechanisms of four insulin-loaded arginine-rich nanoparticles displaying differing composition and surface characteristics, developed within the pan-European consortium TRANS-INT. The transport mechanisms and major barriers to nanoparticle permeability were investigated in freshly isolated human jejunal tissue. Cytokine release profiles and standard toxicity markers indicated that the nanoparticles were nontoxic. Three out of four nanoparticles displayed pronounced binding to the mucus layer and did not reach the epithelium. One nanoparticle composed of a mucus inert shell and cell-penetrating octarginine (ENCP), showed significant uptake by the intestinal epithelium corresponding to 28 ± 9% of the administered nanoparticle dose, as determined by super-resolution microscopy. Only a small fraction of nanoparticles taken up by epithelia went on to be transcytosed via a dynamin-dependent process. In situ studies in intact rat jejunal loops confirmed the results from human tissue regarding mucus binding, epithelial uptake, and negligible insulin bioavailability. In conclusion, while none of the four arginine-rich nanoparticles supported systemic insulin delivery, ENCP displayed a consistently high uptake along the intestinal villi. It is proposed that ENCP should be further investigated for local delivery of therapeutics to the intestinal mucosa.
|
|
| 3. |
- Stenberg, Erik, 1979-, et al.
(författare)
-
Factors determining chance of type 2 diabetes remission after Roux-en-Y gastric bypass surgery : a nationwide cohort study in 8057 Swedish patients
- 2021
-
Ingår i: BMJ Open Diabetes Research & Care. - : BMJ Publishing Group Ltd. - 2052-4897. ; 9:1
-
Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Bariatric and metabolic surgery is an effective treatment option for type 2 diabetes (T2D). Increased knowledge regarding factors associated with diabetes remission is essential in individual decision making and could guide postoperative care. Therefore, we aimed to explore factors known to affect the chance of achieving diabetes remission after bariatric and metabolic surgery and to further investigate the impact of socioeconomic factors.RESEARCH DESIGN AND METHODS: In this nationwide study, we assessed all patients with T2D who underwent Roux-en-Y gastric bypass (RYGB) surgery between 2007 and 2015 in the Scandinavian Obesity Surgery Registry. Remission was defined as absence of antidiabetic medication for T2D 2 years after surgery. Multivariable logistic regression was used to evaluate factors associated with diabetes remission, with missing data handled by multiple imputations.RESULTS: , mean hemoglobin A1c 59.0±17.33, and 61.7% (n=4970) were women. Two years after surgery, 6211 (77.1%) patients achieved T2D remission. Preoperative insulin treatment (OR 0.26, 95% CI 0.22 to 0.30), first-generation immigrant (OR 0.66, 95% CI 0.57 to 0.77), duration of T2D (OR 0.89, 95% CI 0.88 to 0.90), dyslipidemia (OR 0.71, 95% CI 0.62 to 0.81), age (OR 0.97, 95% CI 0.96 to 0.97), and high glycosylated hemoglobin A1c (HbA1c) (OR 0.99, 95% CI 0.98 to 0.99) were all associated with lower T2D remission rate. In contrast, residence in a medium-sized (OR 1.39, 95% CI 1.20 to 1.61) or small (OR 1.46, 95% CI 1.25 to 1.71) town and percentage of total weight loss (OR 1.04, 95% CI 1.03 to 1.04) were associated with higher remission rates.CONCLUSION: Among patients with T2D undergoing RYGB surgery, increasing age, HbA1c, and diabetes duration decreased the chance of reaching diabetes remission without cut-offs, while postoperative weight loss demonstrated a positive linear association. In addition, being a first-generation immigrant and living in a large city were socioeconomic factors having a negative association.
|
|
