BACKGROUND: Diabetes mellitus (DM) significantly impacts global health and economies. Despite various therapies, managing DM remains challenging. Bariatric surgery has shown efficacy in obese patients with type 2 diabetes mellitus (T2DM), but its utilization remains low. Innovative, less invasive endoscopic approaches such as duodenal mucosal resurfacing show potential in treating T2DM. This article presents the results of a First in Human (FIH) study using a duodenal submucosal laser ablation investigational device for T2DM treatment. METHODS: A prospective, single-arm, open-label study evaluated the safety and efficacy of the Digma System Endoscopic procedure for duodenal submucosal laser ablation in consecutive enrolled T2DM patients. RESULTS: The study was conducted from July 2017 to December 2020 and enrolled 31 patients for the Digma System Endoscopic procedure. The Dose Escalation Cohort (DEC) used sub-therapeutic laser doses for training and safety. The Treatment Cohort (TC) of 25 patients received therapeutic doses, resulting in HbA1c reductions of -0.6% at 6 months (p = 0.014) and -0.4% at 12 months (p = 0.062). Fasting glucose dropped 17.3 mg/dL (p = 0.173) at 6 months and 28 mg/dL (p = 0.022) at 12 months. Post-prandial glucose improvements were also observed. HOMA-IR improved at 3 and 6 months. PAGI-SYM and PAGI-QOL showed stable to slightly improved GI symptoms and quality of life. Two severe adverse events were unrelated to the procedure. CONCLUSION: The study demonstrates the safety, feasibility, and potential efficacy of the Digma System Endoscopic procedure. Evidence suggests improvements in HbA1c, fasting and post-prandial glucose, and HOMA-IR levels could be attributed to the Digma System Endoscopic procedure.
- Keywords
- duodenal mucosal resurfacing, endoscopy, metabolism, type 2 diabetes mellitus,
- MeSH
- Diabetes Mellitus, Type 2 * surgery blood MeSH
- Adult MeSH
- Duodenum * surgery MeSH
- Glycated Hemoglobin analysis metabolism MeSH
- Blood Glucose analysis metabolism MeSH
- Quality of Life MeSH
- Laser Therapy * methods adverse effects instrumentation MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged MeSH
- Intestinal Mucosa surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Glycated Hemoglobin MeSH
- hemoglobin A1c protein, human MeSH Browser
- Blood Glucose MeSH
- MeSH
- Bariatric Surgery * instrumentation MeSH
- Duodenum * surgery MeSH
- Jejunum * surgery MeSH
- Humans MeSH
- Check Tag
- Humans MeSH
- Publication type
- Video-Audio Media MeSH
- Journal Article MeSH
- Case Reports MeSH
BACKGROUND: Conservative treatment of chronic pancreatitis has only a limited effect in most patients. Surgery offers very good long-term results, even in the early stages of the disease. Unfortunately, only a minority of patients undergo surgical treatment. The aim of this work was to summarise the current treatment options for patients with an inflammatory mass of the pancreatic head. Data from patients in our study demonstrates that the surgery is a safe method, and here we compare the perioperative and early postoperative outcomes of patients who underwent a pancreatoduodenectomy and duodenum-preserving pancreatic head resection for chronic pancreatitis. METHODS: All patients who underwent a pancreaticoduodenectomy or a duodenum-preserving pancreatic head resection in our department between 2014 and 2022 were included in this study. Perioperative and early postoperative results were statistically analysed and compared. RESULTS: Thirty-eight pancreaticoduodenectomies and 23 duodenum-preserving pancreatic head resections were performed. The overall mortality was 3%, whereas the in-hospital mortality after pancreaticoduodenectomy was 5%. The mortality after duodenum-preserving pancreatic head resection was 0%. No statistically significant differences in the hospital stay, blood loss, and serious morbidity were found in either surgery. Operative time was significantly shorter in the duodenum-preserving pancreatic head resection group. CONCLUSIONS: Both pancreatoduodenectomy and duodenum-preserving pancreatic head resection are safe treatment options. Duodenum-preserving pancreatic head resection showed a statistically significant superiority in the operative time compared to pancreaticoduodenectomy. Although other monitored parameters did not show a statistically significant difference, the high risk of complications after pancreaticoduodenectomy with a mortality of 5%; maintenance of the duodenum and upper loop of jejunum, and lower risk of metabolic dysfunctions after duodenum-preserving pancreatic head resection may favour duodenum-preserving pancreatic head resection in recommended diagnoses. Attending physicians should be more encouraged to use a multidisciplinary approach to assess the suitability of surgical treatment in patients with chronic pancreatitis.
- Keywords
- Beger, Chronic pancreatitis, Duodenum-preserving pancreatic head resection, Inflammatory pancreatic head mass, Pancreatic surgery, Pancreaticoduodenectomy,
- MeSH
- Pancreatitis, Chronic * surgery MeSH
- Operative Time * MeSH
- Length of Stay statistics & numerical data MeSH
- Adult MeSH
- Duodenum surgery pathology MeSH
- Organ Sparing Treatments methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Hospital Mortality MeSH
- Pancreas * surgery pathology MeSH
- Pancreatectomy methods adverse effects MeSH
- Pancreaticoduodenectomy * methods adverse effects MeSH
- Postoperative Complications etiology epidemiology MeSH
- Retrospective Studies MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
We present a case of obstruction in the third portion of the duodenum secondary to a phytobezoar in an adult patient with no surgical history and without a vegan diet. High intestinal obstruction due to a phytobezoar is rarely described in the literature, posing a diagnostic challenge when evaluating potential differentials in the emergency setting. Subsequently, we conduct a review focusing on tomographic findings and the surgical specimen, highlighting key points to consider when addressing such pathologies.
- Keywords
- Abdomen, Acute, Bezoars, Intestinal obstruction, Tomography,
- MeSH
- Bezoars * surgery diagnosis MeSH
- Duodenum MeSH
- Middle Aged MeSH
- Humans MeSH
- Duodenal Obstruction etiology diagnosis surgery MeSH
- Tomography, X-Ray Computed MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
PURPOSE: Obesity and its related severe comorbidities are increasing rapidly. The duodenal-jejunal bypass is an endoscopically implanted device (mimicking the Roux-en-Y gastric bypass) developed to support weight reduction and improve type 2 diabetes control. MATERIALS AND METHODS: Retrospective data analysis of consecutive patients undergoing duodenal-jejunal bypass (EndoBarrier®, DJB) implantation between 2013 and 2017 was performed to evaluate safety as well as short- and long-term efficacy. RESULTS: One hundred and twenty-one patients (mean BMI of 43.1 ± 7.2 kg/m2 and weight of 138.2 ± 28.6 kg) underwent DJB implantation. The mean dwelling time was 15.5 months, the mean total body weight loss (%TBWL) after explantation was 10.3% ± 7.9% (14.2 kg, p < 0.0001), and the mean BMI was 39.5 ± 7.3 kg/m2 (p < 0.0001). There was no significant weight gain 24 months after the explantation. Seventy-seven patients had type 2 diabetes mellitus (T2DM) with a mean HbA1c before implantation of 5.6% (n = 52). The mean HbA1c after explantation was 5.1% (p = 0.0001). Significant reductions in transaminase and lipid levels before and after explantation were observed. One complication occurred during implantation and another during explantation. In 16 patients, the device had to be extracted earlier than expected (7 for severe adverse events and 9 for adverse events; 13.2%). CONCLUSION: Despite an evident rate of adverse events, the DJB shows promise as a weight-loss procedure. Our results show that some patients implanted with the device maintained reduced weight even 24 months after explantation, while many improved T2DM control.
- Keywords
- Bariatric, Duodenal-jejunal bypass, Endoscopy, Obesity, Type 2 diabetes mellitus,
- MeSH
- Diabetes Mellitus, Type 2 * surgery complications MeSH
- Duodenum surgery MeSH
- Glycated Hemoglobin MeSH
- Weight Loss MeSH
- Jejunum surgery MeSH
- Humans MeSH
- Obesity, Morbid * surgery MeSH
- Obesity surgery complications MeSH
- Retrospective Studies MeSH
- Treatment Outcome MeSH
- Gastric Bypass * methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Glycated Hemoglobin MeSH
- MeSH
- Bariatric Surgery * adverse effects MeSH
- Diabetes Mellitus, Type 2 * complications surgery MeSH
- Duodenum surgery MeSH
- Cardiovascular Diseases * surgery MeSH
- Humans MeSH
- Obesity, Morbid * complications surgery MeSH
- Obesity complications surgery MeSH
- Risk Factors MeSH
- Treatment Outcome MeSH
- Gastric Bypass * adverse effects MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
Many environmental risk factors for hepatobiliary cancers are known but whether they are associated with specific cancer types is unclear. We present here a novel approach of assessing standardized incidence ratios (SIRs) of previously diagnosed comorbidities for hepatocellular carcinoma (HCC), gallbladder cancer (GBC), cholangiocarcinoma (CCA) and ampullary cancer. The 13 comorbidities included alcohol and nonalcohol related liver disease, chronic obstructive pulmonary disease, gallstone disease, viral and other kinds of hepatitis, infection of bile ducts, hepatic and other autoimmune diseases, obesity and diabetes. Patients were identified from the Swedish Inpatient Register from 1987 to 2018, and their cancers were followed from 1997 onwards. SIRs for HCC were 80 to 100 in men and women diagnosed with hepatitis C virus and they were also >10 in patients diagnosed with hepatitis B virus, other kind of hepatitis, hepatic autoimmune disease and nonalcohol related liver disease. Many of these risks, as well as alcohol related liver disease, were either specific to HCC or were shared with intrahepatic CCA. For GBC, CCA and ampullary cancer infection of bile ducts was the main risk factor. Gallstone disease, nonhepatic autoimmune diseases and diabetes were associated with all hepatobiliary cancers. The limitations of the study include inability to cover some rare risk factors and limited follow-up time. Many of the considered comorbidities are characterized by chronic inflammation and/or overt immune disturbance in autoimmune diseases. The results suggest that local chronic inflammation and a related immune disturbance is the carcinogenic trigger for all these cancers.
- Keywords
- alcohol, comorbidity, familial risk, hepatocellular carcinoma, risk factor, smoking,
- MeSH
- Ampulla of Vater * pathology MeSH
- Autoimmune Diseases * MeSH
- Cholangiocarcinoma * epidemiology etiology diagnosis MeSH
- Cholelithiasis * complications pathology MeSH
- Carcinoma, Hepatocellular * pathology MeSH
- Humans MeSH
- Common Bile Duct Neoplasms * complications pathology MeSH
- Liver Neoplasms * epidemiology etiology pathology MeSH
- Gallbladder Neoplasms * etiology complications MeSH
- Bile Duct Neoplasms * epidemiology etiology pathology MeSH
- Inflammation pathology MeSH
- Bile Ducts, Intrahepatic pathology MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND: The aim of this study was to evaluate symptoms, diagnostic methods, short- and long-term outcomes of surgical treatment in patients with duodenal adenocarcinoma. PATIENTS AND METHODS: A single center, retrospective, observational study of 52 consecutive patients with duodenal adenocarcinoma operated on with curative intent between 2006 - 2019. Duodenectomy as part of a hemipancreatoduodenectomy or total pancreatectomy procedure was performed for ADAC (ampullary duodenal/intestinal adenocarcinoma) or NADAC (non-ampullary duodenal adenocarcinoma). RESULTS: Prevailing symptoms were obstructive jaundice in the ADAC group (P<0.0001) and bleeding in the NADAC group (P=0.005), with larger tumor size in patients with NADAC (P=0.001). Complication rate, morbidity and mortality were comparable. Primary total pancreatoduodenectomy predominated in the NADAC group, 16.6% vs. 2.9%, and salvage completion pancreatectomy in the ADAC group, 6% vs. 0%. Significant prognostic factors for OS were perineural invasion (P=0.006) and adjuvant chemotherapy (P=0.045) in the ADAC group, and for DFS the total number of resected lymph nodes (P=0.042) and lymph node ratio (P=0.031) in the NADAC group. Median OS is 21 months and 5-year survival 27.3% in the NADAC group and 41.5 months and 52% in the ADAC group. CONCLUSION: Ampullary duodenal/intestinal adenocarcinomas are smaller than non-ampullary at diagnosis, with a higher rate of lymph node metastases, but with a better prognosis and long-term outcome in the presented cohort. Oral localisation of NADAC prevailed in the present cohort. Perineural invasion and postoperative oncological therapy are significant prognostic factors for OS in ADAC, but the total number of lymph nodes and lymph node ratio are significant prognostic factors for DFS in NADAC.
- Keywords
- ampullary carcinoma, duodenal carcinoma, long-term survival, non-ampullary carcinoma, outcomes,
- MeSH
- Adenocarcinoma * pathology surgery MeSH
- Ampulla of Vater * pathology surgery MeSH
- Humans MeSH
- Common Bile Duct Neoplasms * pathology surgery MeSH
- Duodenal Neoplasms * pathology surgery MeSH
- Pancreatic Neoplasms MeSH
- Prognosis MeSH
- Retrospective Studies MeSH
- Neoplasm Staging MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
In this case report is discussed the diagnosis of papillary carcinoma in the case of a patient in whose age the occurrence of the disease is very rare. The patient underwent a series of non-invasive and invasive examinations, the results of which eventually led to a surgical solution of the suspected lesion (Wipples procedure). Histological examination of the resection confirmed mixed type ampular adenocarcinoma. In the context of this finding, the results of the examination, their information value, interpretation and mutual interaction are discussed. In the postoperative period, the patient suffered from gastrointestinal bleeding, subileum and poor postoperative healing. After hospitalization, the patient was transferred to oncology care and indicated for genetic testing.
- Keywords
- Whipple procedure, carcinoma of the papilla of Vater, familial adenomatous polyposis, obstructive icterus,
- MeSH
- Adenocarcinoma * complications diagnosis MeSH
- Ampulla of Vater * pathology surgery MeSH
- Adenomatous Polyposis Coli * surgery MeSH
- Humans MeSH
- Common Bile Duct Neoplasms * diagnosis pathology surgery MeSH
- Jaundice * pathology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
Duodenum is currently the most popular site to obtain samples of intestinal mucosa for recognition of a disorder leading to malabsorption. Although there are significant overlaps between histological findings described in various non-neoplastic diseases of the duodenum, recognition of one of the six basic morphologic patterns, namely coeliac disease-like pattern, active chronic duodenitis, acute GvHD-like pattern, enteritis with predominant eosinophilic infiltration, enteritis with predominant infiltration by macrophages, and non-inflammatory enteropathy, usually allows diagnostic separation, especially if subtle histological details, clinical setting and serological investigation are taken into account.
- Keywords
- Biopsy, duodenitis, duodenopathy, duodenum, endoscopy, pattern,
- MeSH
- Biopsy MeSH
- Celiac Disease * diagnosis pathology MeSH
- Duodenitis * diagnosis pathology MeSH
- Duodenum pathology MeSH
- Enteritis * diagnosis pathology MeSH
- Humans MeSH
- Intestinal Mucosa pathology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH