Artificial Intelligence and ChatGPT in Abdominopelvic Surgery: A Systematic Review of Applications and Impact.

BACKGROUND/AIM: The integration of AI and natural language processing technologies, such as ChatGPT, into surgical practice has shown promising potential in enhancing various aspects of abdominopelvic surgical procedures. This systematic review aims to comprehensively evaluate the current state of research on the applications and impact of artificial intelligence (AI) and ChatGPT in abdominopelvic surgery summarizing existing literature towards providing a comprehensive overview of the diverse applications, effectiveness, challenges, and future directions of these innovative technologies. MATERIALS AND METHODS: A systematic search of major electronic databases, including PubMed, Google Scholar, Cochrane Library, Web of Science, was conducted from October to November 2023, to identify relevant studies. Inclusion criteria encompassed studies that investigated the utilization of AI and ChatGPT in abdominopelvic surgical settings, including, but not limited to preoperative planning, intraoperative decision-making, postoperative care, and patient communication. RESULTS: Fourteen studies met the inclusion criteria and were included in this review. The majority of the studies were analysing ChatGPT's data output and decision making while two studies reported patient and general surgery resident perception of the tool applied to clinical practice. Most studies reported a high accuracy of ChatGPT in data output and decision-making process, however with an unforgettable number of errors. CONCLUSION: This systematic review contributes to the current understanding of the role of AI and ChatGPT in abdominopelvic surgery, providing insight into their applications and impact on clinical practice. The synthesis of available evidence will inform future research directions, clinical guidelines, and development of these technologies to optimize their potential benefits in enhancing surgical care within the abdominopelvic domain.

Analysis of Factors Related to Gastroesophageal Reflux After Gastric Bypass at 10-Year Follow-up: A Retrospective Single-institutional Study.

BACKGROUND/AIM: Long-term gastroesophageal reflux (GERD) after gastric bypass for obesity is underestimated. The present study aimed to evaluate the rate of treated GERD and the factors influencing it in a cohort of patients who underwent gastric bypass. PATIENTS AND METHODS: Patients who underwent one-anastomosis gastric bypass (OAGB) or Roux-en-Y gastric bypass (RYGB) as a primary bariatric procedure between 2010 and 2011 at a French private referral center were included in the study. The primary endpoint was the 10-year prevalence of GERD. RESULTS: In total, 422 patients underwent RYGB and 334 underwent OAGB with a biliopancreatic limb of 150 cm. The mean age was 38.9±11.3 years, and 81.6% of patients were female; the mean preoperative body mass index was 42.8±5 kg/m2 Preoperative GERD was diagnosed in 40.8% of patients in the total cohort, 31.7% in the RYGB group versus 49.1% in the OAGB group (p<0.0001). At 10-year follow-up, the rate of GERD was 21.1%, with no difference between the two groups. Remission of preoperative GERD and de novo GERD were comparable between the two types of bypass. Surgery for GERD resistant to medical treatment was more frequent in the OAGB group. At multivariate analysis, factors significantly correlated with long-term GERD were: Preoperative GERD, total weight loss at 120 months <25%, glycemic imbalances and anastomotic ulcers. CONCLUSION: Identification and correction of modifiable factors may help reduce the incidence of long-term GERD.

Large and bleeding gastroduodenal artery aneurysm: Challenging diagnosis and treatment. A case report.

INTRODUCTION: Visceral artery aneurysms (VAA), including gastroduodenal artery aneurysms (GAA), are rare pathologies that can be challenging to diagnose due to their often-asymptomatic nature. VAA are usually correlated to atherosclerosis, fibro dysplasia, or hemodynamics changes, while pseudo aneurysms are mostly correlated to infection, inflammation, traumas, or iatrogenic lesions. PRESENTATION OF CASE: We report the case of an 82-years-old female presenting with abdominal pain and hematemesis. Upper gastrointestinal endoscopy retrieved a large duodenal mass and subsequent CT scans identified a large GAA with contrast extravasation. Endovascular procedure included selective arteriography, microcatheterization, and embolization. DISCUSSION: VAA are mostly located in the splenic and hepatic artery. Symptoms of VAA are related to pressure on neighboring organs. VAA rupture is associated with a high mortality risk (over 76 %) and presents with symptoms like acute abdominal pain, hematemesis, and hemodynamic shock. Diagnosis is often made through CT scans and angiography. Treatment options for VAAs and GAAs include both surgical and endovascular methods. Endovascular treatment is preferred, with a success rate of 89 %-98 %. CONCLUSION: This case provides an example of challenging diagnosis and treatment of a large and bleeding GAA.

Wandering spleen causing small bowel obstruction: Laparoscopic surgical treatment (with video).

INTRODUCTION: Wandering spleen (WS) is a clinical entity in which the spleen is not located in its normal anatomical site. Few cases have been reported, mainly in women of childbearing age. This condition can be congenital or acquired due to excessive elasticity of the spleen's suspensory ligaments. WS may cause acute complications requiring emergency surgery, especially related to the rotation of its vascular pedicle, leading to chronic or acute ischemia. The aim of the present case is to show a rare complication of WS, small bowel obstruction (SBO), and its management. PRESENTATION OF CASE: We report the case of a 40-year-old female presenting with abdominal pain, nausea, and vomiting. CT scan showed SBO caused by WS located in the pelvis with an enlarged spleen vascular pedicle (SVP). Laparoscopic exploration, splenectomy, small bowel resection and anastomosis were performed. DISCUSSION: WS may cause chronic or acute complications, mainly linked with enlargement and torsion of SVP, including acute ischemia and spleen necrosis, or compression of the near organs such as small intestine, stomach, pancreas. The diagnosis is based on physical examination, CT scan and blood exams. Generally, the WS's treatment is laparoscopic splenectomy or splenopexy. In case of vital spleen, splenopexy can be performed, in case of not vital spleen, splenectomy should be preferred. CONCLUSION: This case provides an excellent example of SBO related to WS. In the video, the management of this complex situation is shown. In these cases, splenectomy represents a valuable option.

Complication of Gastric Cancer Surgery: A Single Centre Experience.

BACKGROUND/AIM: Gastric cancer surgery is still characterised by high morbidity and mortality. However, in 2018 an online platform, GASTRODATA has been proposed in Europe to standardize the recording of gastric surgery complications. The aim of the study was to present a single center experience regarding incidence and grading of acute postoperative complications in a population of patients treated surgically for gastric cancer on the basis of the gastrodata online platform. PATIENTS AND METHODS: The present study was a single center, observational, retrospective trial held in the General Surgery Unit of the Sant'Andrea Hospital of Rome. The study included 181 consecutive patients who underwent gastric surgical resection for cancer from May 2004 to December 2020 with curative R0 purpose. RESULTS: Thirty-three percent of patients reported at least one complication, while seventeen percent of the whole population reported a complication classified as at least grade 3 on the Clavien Dindo Classification. The most frequent complications were disorders of the respiratory system (13.3%), followed by bleeding (7.6%) and wound infections (6.2%). Deaths accounted for 3.7% of the population. CONCLUSION: A list of defined complications of gastrectomy, if systematically adopted in the Literature, could lead to a reduction in the wide variation of proposals for treatment and assessment. Objectively evaluating the impact of complications on outcomes can lead to quality improvement project proposals.

Overall Survival Following Anastomotic Leakage After Surgery for Carcinoma of the Esophagus and Gastroesophageal Junction: A Systematic Review.

The effect of anastomotic leakage, in patients who underwent surgery for carcinoma of the esophagus and gastroesophageal junction, on overall survival (OS) is a debated and controversial topic. The aim of this systematic review was to clarify the impact of anastomotic leakage on long-term survival of patients with esophageal cancer undergoing esophagectomy. A systematic literature review was carried out from 2000 to 2022. We chose articles reporting data from patients who underwent surgery for carcinoma of the esophagus and gastroesophageal junction. Data regarding 1-, 3- and 5-year OS were analyzed. Twenty studies met the inclusion criteria, yielding a total of 9,279 patients. Analyzing data from selected studies, anastomotic leakage was found to be associated with decreased OS in 5,456 cases while in the remaining 3,823 it had no impact on long term survival (p<0.05). However, this result did not emerge from the other studies considered in the systematic review. Anastomotic leakage is a severe postoperative complication, which seems to have an impact on overall survival. However, the topic remains debated and not supported by all case series included in this systematic review.

Postoperative Pancreatic Fistula: Is Minimally Invasive Surgery Better than Open? A Systematic Review and Meta-analysis.

BACKGROUND/AIM: Minimally invasive pancreaticoduodenectomy (PD) is gaining popularity. The aim of this study was to compare the incidence of postoperative pancreatic fistula (POPF) after minimally invasive versus open procedures. MATERIALS AND METHODS: Following the PRISMA statement, literature research was conducted focusing on papers comparing the incidence of POPF after open pancreaticoduodenectomy (OPD) versus minimally invasive pancreaticoduodenectomy (MIPD). RESULTS: Twenty-one papers were included in this meta-analysis, for a total of 4,448 patients. A total of 2,456 patients (55.2%) underwent OPD, while 1,992 (44.8%) underwent MIPD. Age, ASA score III patients, incidence of pancreatic ductal adenocarcinoma and duct diameter were significantly lower in the MIPD group. No statistically significant differences were found between the OPD and MIPD regarding the incidence of major complications (15.6% vs. 17.0%, respectively, p=0.55), mortality (3.7% vs. 2.4%, p=0.81), and POPF rate (14.3% vs. 12.9%, p=0.25). CONCLUSION: MIPD and OPD had comparable rates of postoperative complications, postoperative mortality, and POPF.

Preliminary Results of the First 50 Patients Undergoing Sclerotherapy for II-Degree Hemorrhoidal Disease Using an Automated Device.

Background: Sclerotherapy is defined as the injection of sclerosant agents causing fibrosis and scarring of the surrounding tissue. It is currently employed for the treatment of I-III degree hemorrhoidal disease (HD). The aim of this study is to investigate the use of a new automated device for the injection of 3% polidocanol foam. Methods: This is an observational study including 50 patients who underwent a sclerotherapy procedure with 3% polidocanol foam for II-degree HD according to Goligher classification. Patients were evaluated through validated scores [Giamundo score, Hemorrhoidal Disease Symptom Score (HDSS), Short Health Scale (SHS-HD) and Vaizey score]. Follow-up was conducted until 3 months from the procedure. Results: Complete resolution of bleeding was achieved in 72% and 78% of patients, respectively, at 1 week and after 3 months from the procedure. Forty eight percent of patients were symptom free after the last follow-up visit (HDSS = 0). No major surgical complications were reported. Three patients out of 36 successfully treated, recurred, and needed a second sclerotherapy injection, which was successful in 2 of them. Conclusion: These preliminary results of 3% polidocanol foam injection on 50 patients suggest the efficacy and reproducibility of the technique with this new device in the short-term follow-up.

The Role of Surgery in the Treatment of Metachronous Liver Metastasis from Gastric Cancer: A Systematic Review.

BACKGROUND: Few data are available regarding metachronous liver metastases from gastric cancer. We aimed to identify data regarding the survival of these patients, considering the chosen treatment, with particular attention to the role of surgery. MATERIALS AND METHODS: A systematic review was carried out from 2000 to 2020. We chose articles reporting data from patients with metachronous liver metastases after curative gastrectomy. Data regarding 1-, 3- and 5-year overall survival were analyzed. RESULTS: Survival was improved in patients eligible for surgery (absence of extrahepatic non-curative factors and feasible complete macroscopic removal of liver deposits, i.e., H1 and H2 liver involvement, metastases less than 5 cm in size) when curative liver resection was performed, with a median overall survival of 24 months (vs. 3.13 in patients treated with chemotherapy). N Status, extent and maximum size of liver metastases, and hepatic surgical treatment were identified as independent prognostic factors. CONCLUSION: Selected patients with metachronous liver metastases from gastric cancer may benefit from multimodal 'aggressive' treatment. When hepatic involvement is limited (H1 and H2) and the size of metastases less than 5 cm, surgery was shown to increase survival.

Distal Pancreatectomy with Celiac Axis Resection: Systematic Review and Meta-Analysis.

BACKGROUND: Major vascular invasion represents one of the most frequent reasons to consider pancreatic adenocarcinomas unresectable, although in the last decades, demolitive surgeries such as distal pancreatectomy with celiac axis resection (DP-CAR) have become a therapeutical option. METHODS: A meta-analysis of studies comparing DP-CAR and standard DP in patients with pancreatic adenocarcinoma was conducted. Moreover, a systematic review of studies analyzing oncological, postoperative and survival outcomes of DP-CAR was conducted. RESULTS: Twenty-four articles were selected for the systematic review, whereas eleven were selected for the meta-analysis, for a total of 1077 patients. Survival outcomes between the two groups were similar in terms of 1 year overall survival (OS) (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.34 to 1.31, p = 0.24). Patients who received DP-CAR were more likely to have T4 tumors (OR 28.45, 95% CI 10.46 to 77.37, p < 0.00001) and positive margins (R+) (OR 2.28, 95% CI 1.24 to 4.17, p = 0.008). Overall complications (OR, 1.72, 95% CI, 1.15 to 2.58, p = 0.008) were more frequent in the DP-CAR group, whereas rates of pancreatic fistula (OR 1.16, 95% CI 0.81 to 1.65, p = 0.41) were similar. CONCLUSIONS: DP-CAR was not associated with higher mortality compared to standard DP; however, overall morbidity was higher. Celiac axis involvement should no longer be considered a strict contraindication to surgery in patients with locally advanced pancreatic adenocarcinoma. Considering the different baseline tumor characteristics, DP-CAR may need to be compared with palliative therapies instead of standard DP.

Left-sided portal hypertension after pancreatoduodenectomy with resection of the portal/superior mesenteric vein confluence. Results of a systematic review.

BACKGROUND: Pancreatoduodenectomy with synchronous resection of the portal vein/superior mesenteric vein confluence may result in the development of left-sided portal hypertension. Left-sided portal hypertension presents with splenomegaly and varices and may cause severe gastrointestinal bleeding. The aim of the study is to review the incidence, treatment, and preventive strategies of left-sided portal hypertension. METHODS: A systematic literature search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement to identify all studies published up to September 30, 2019 reporting data on patients with left-sided portal hypertension after pancreatoduodenectomy with venous resection. RESULTS: Eight articles including 829 patients were retrieved. Left-sided portal hypertension occurred in 7.7% of patients who had splenic vein preservation and 29.4% of those having splenic vein ligation. Fourteen cases of gastrointestinal bleeding owing to left-sided portal hypertension were reported at a mean interval of 28 months from pancreatoduodenectomy. Related mortality at 1 month was 7.1%. Treatment of left-sided portal hypertension consisted of splenectomy in 3 cases (21%) and colectomy in 1 (7%) case, whereas radiologic, endoscopic procedures or conservative treatments were effective in the other cases (71%). CONCLUSION: Left-sided portal hypertension represents a potentially severe complication of pancreatoduodenectomy with venous resection occurring at greater incidence when the splenic vein is ligated and not reimplanted. Left-sided portal hypertension-related gastrointestinal bleeding although rare can be managed depending on the situation by endoscopic, radiologic procedures or operative intervention with low related mortality.

Impact of Anastomotic Leakage on Overall and Disease-free Survival After Surgery for Gastric Carcinoma: A Systematic Review.

BACKGROUND/AIM: Gastric cancer is the fifth most frequently diagnosed cancer and the second most common cause of cancer-related death. The only potentially curative treatment is surgical resection, which is associated with potentially severe complications, such as anastomotic leakage. The aim of this systematic review was to evaluate the relationship between anastomotic leakage and overall and disease-free survival after surgery for gastric cancer. MATERIALS AND METHODS: A systematic literature search was performed and 7 articles published between 2010 and 2019 were included, including a total of 7,167 patients. RESULTS: Among the included studies the frequency of anastomotic leakage ranged from 6 to 41%. Patients affected by anastomotic leakage had an overall survival ranging between 4.1 and 97.6 months, whereas patients who did not experience anastomotic leakage had an overall survival between 23 and 109.5 months. CONCLUSION: Closer follow-up or even more aggressive oncological therapy may be considered for patients affected by anastomotic leakage after surgery for gastric cancer.

In vivo Bioluminescence-Based Monitoring of Liver Metastases from Colorectal Cancer: An Experimental Model.

BACKGROUND: In this study we aimed to develop a new in vivo bioluminescence-based tool to monitor and to quantify colon cancer (CC) liver metastasis development. METHODS: HCT 116 cells were transducted with pLenti6/V5-DEST-fLuc for constitutive expression of firefly luciferase. Infection was monitored analyzing endogenous bioluminescence using the IVIS Lumina II In vivo Imaging System and a positive clone constitutively expressing luciferase (HCT 116-fLuc) was isolated. HCT 116-fLuc cells were left untreated or treated with 1 µM GDC-0449, a Hedgehog pharmacological inhibitor. Moreover, 1 x 106 HCT 116-fLuc cells were implanted via intra-splenic injection in nude mice. Bioluminescence was analyzed in these mice every 7 days for 5 weeks. After that, mice were sacrificed and bioluminescence was analyzed on explanted livers. RESULTS: We found that in vitro bioluminescence signal was significantly reduced when HCT 116-fLuc cells were treated with GDC-0449. Regarding in vivo data, bioluminescence sources consistent with hepatic anatomical localization were detected after 21 days from HCT 116-fLuc intrasplenic injection and progressively increased until the sacrifice. The presence of liver metastasis was further confirmed by ex-vivo bioluminescence analysis of explanted livers. CONCLUSIONS: Our in vitro results suggest that inhibition of Hedgehog pathway may hamper CC cell proliferation and impel for further studies. Regarding in vivo data, we set-up a strategy for liver metastasis visualization, that may allow follow-up and quantification of the entire metastatic process. This cost-effective technique would reduce experimental variability, as well as the number of sacrificed animals.

Recurrence Following Anastomotic Leakage After Surgery for Carcinoma of the Distal Esophagus and Gastroesophageal Junction: A Systematic Review.

BACKGROUND: Esophageal cancer is the ninth most common cancer. The only potentially curative treatment is surgical resection, which unfortunately is still associated with major complications, the most important being anastomotic leakage, currently with an overall rate of up to 26% morbidity. The aim of this systematic review was to evaluate the relationship between anastomotic leakage and recurrence of disease. MATERIALS AND METHODS: A literature search was systematically performed. Seven out of 312 articles dated between 2009 and 2018 fulfilled the selection for a total of 5,433 patients. RESULTS: The frequency of anastomotic leakage ranged from 7.2 to 11.2%. Patients affected by anastomotic leakage had a recurrence rate of 9-56%. CONCLUSION: Closer follow-up or even more aggressive oncological therapy should be considered for patients affected by anastomotic leakage after surgery for carcinoma of the distal esophagus and gastroesophageal junction.

An unusual cause of colic stenosis in a renal transplant recipient: primary colonic diffuse large B-cell lymphoma.

BACKGROUND: Primary colic lymphoma represents a rare disease accounting for the 0.2%-0.6% of all large-bowel malignancies. We here report a case of diffuse large B-cell lymphoma presenting as a left colic stenosis in a patient who had undergo renal transplant 23 years before. CASE REPORT: A 67-years old man presented with recurrent abdominal pain, distension, nausea and constipation since 3 weeks. His past medical history included hepatic and renal polykystose with renal transplant 23 years before. Colonoscopy revealed a non-surmountable inflammatory left colic stenosis at 55 cm from the anal verge. Biopsies demonstrated inflammatory colic mucosa without neoplastic cells. Non-enhanced CT scan and CT virtual colonoscopy were performed, showing a left colon circumferential thickening of 4 cm. Laparoscopic left colectomy was performed to treat the colic obstructive syndrome and to have complete specimen analysis. After Pathological analysis and Immunohistochemistry the diagnosis of diffuse large B cell lymphoma was established. The resection was R0. The postoperative course was uneventfully. CONCLUSION: Large B-cell lymphoma represents a rare case of bowel tumor. However it has to be considered in the differential diagnosis of colic stenosis in immunosuppressed patients as transplant recipients. KEY WORDS: Colorectal lymphoma, Diffuse large B-cell lymphoma, Immunosuppressed patients.

Is a Surgical Approach Justified in Metachronous Krukenberg Tumor from Gastric Cancer? A Systematic Review.

BACKGROUND: The treatment of metachronous Krukenberg tumor (mKT) from gastric cancer remains unexplored. We performed a literature review to evaluate whether or not surgical treatment improves survival. METHODS: A systematic review according to PRISMA guidelines was performed. Studies reporting on patients who underwent surgical treatment for mKT from gastric cancer were selected. Metachronous disease was divided as follows: confined to the ovaries, confined to the pelvis, or beyond the pelvis. Outcomes evaluated included overall survival (OS), progression-free survival (PFS), resection rate (R0), and factors predicting survival. RESULTS: 13 retrospective reports fulfilled the selection criteria (512 patients). Most of the patients presented at a premenopausal age. The median presentation interval from gastrectomy ranged from 16 to 21.4 months. Median OS ranged between 9 and 36 months. 1-year OS ranged between 52.5 and 59%, and 3-years OS between 9.8 and 36.5%. Resection margin, peritoneal seeding, and chemotherapy regimen and cycles influenced survival. CONCLUSION: Surgical treatment and adjuvant chemotherapy in patients with mKT from gastric cancer seems to be associated with improved survival and is justified especially in young patients. Disease location and R0 resection should be considered when selecting patients.

Cancer Rate of the Indeterminate Lesions at Low or High Risk According to Italian System for Reporting of Thyroid FNA.

Background: Italian consensus for the classification and reporting of thyroid cytology (ICCRTC) has been used in almost all Italian institutions since 2014. High reliability of ICCRTC in classifying low and high risk indeterminate nodules (Tir 3A and Tir 3B, respectively) was demonstrated. Here we reviewed our casuistry of thyroid indeterminate lesions to analyze the histologic outcome. Methods: All lesions undergone FNA and final histology at S. Andrea Hospital of Rome after a cytologic assessment of Tir 3A and Tir 3B, according to ICCRTC, were included in the study. Results: A number of 157 indeterminate FNA was found after the introduction of ICCRTC. Of these, 75 undergone surgery and were finally included for the study. At histology we found a 33.3% of cancers and a 67.7% of benign lesions. Out of the overall series, 25 were classified as Tir 3A and 50 as Tir 3B. Cancer rate observed in Tir 3A (1/25, 4%) was significantly (p = 0.0002) lower than that of Tir 3B (24/50, 48%). No significant difference was found in age and size between the two subcategories. Conclusions: We confirm in our series that Italian consensus for the classification and reporting of thyroid cytology allows to discriminate indeterminate lesions at low and high risk of malignancy.

Treatment options for PNET liver metastases: a systematic review.

BACKGROUND: Pancreatic neuroendocrine tumors (PNETs) are rare pancreatic neoplasms. About 40-80% of patients with PNET are metastatic at presentation, usually involving the liver (40-93%). Liver metastasis represents the most significant prognostic factor. The aim of this study is to present an up-to-date review of treatment options for patients with liver metastases from PNETs. METHODS: A systematic literature search was performed using the PubMed database to identify all pertinent studies published up to May 2018. RESULTS: The literature search evaluated all the therapeutic options for patients with liver metastases of PNETs, including surgical treatment, loco-regional therapies, and pharmacological treatment. All the different treatment options showed particular indications in different presentations of liver metastases of PNET. Surgery remains the only potentially curative therapeutic option in patients with PNETs and resectable liver metastases, even if relapse rates are high. Efficacy of medical treatment has increased with advances in targeted therapies, such as everolimus and sunitinib, and the introduction of radiolabeled somatostatin analogs. Several techniques for loco-regional control of metastases are available, including chemo- or radioembolization. CONCLUSIONS: Treatment of patients with PNET metastases should be multidisciplinary and must be personalized according to the features of individual patients and tumors.

Can pancreatic cancer be detected by adrenomedullin in patients with new-onset diabetes? The PaCANOD cohort study protocol.

INTRODUCTION: Pancreatic cancer is a leading cause of cancer-related death. Its diagnosis is often delayed and patients are frequently found to have unresectable disease. Patients diagnosed with new-onset diabetes have an 8-fold risk of harboring pancreatic cancer. Adrenomedullin has been claimed to mediate diabetes in pancreatic cancer. New screening tools are needed to develop an early diagnosis protocol. METHODS: Patients aged 45-75 years within 2 years of first fulfilling the ADA criteria for diabetes will be prospectively enrolled in this study. Sepsis, renal failure, microangiopathy, pregnancy, acute heart failure and previous malignancies will be considered as exclusion criteria. RESULTS: 440 patients diagnosed with new-onset diabetes will be enrolled and divided into 2 groups: one with high adrenomedullin levels and one with low adrenomedullin levels. Patients will undergo 3 years' follow-up to detect pancreatic cancer development. CONCLUSIONS: Identifying a marker for pancreatic cancer among high-risk patients such as new-onset diabetics might lead to the identification of a subpopulation needing to be screened in order to enable early diagnosis and treatment of a highly lethal tumor. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov on May 25, 2015 under registration number NCT02456051.