Tissue amount and diagnostic yield of a novel franseen EUS-FNB and a standard EUS-FNA needle-A randomized controlled study in solid pancreatic lesions.

Background and Objectives: Several types of needles are available for EUS-guided tissue sampling of pancreatic lesions. Whereas fine-needle aspiration (FNA) needles typically provide cytological samples, fine-needle biopsy (FNB) needles are designed to obtain microcores with preserved tissue architecture. The aim of this study was to compare tissue amount and diagnostic yield between a modified Franseen-type FNB needle (TopGain; Medi-Globe GmbH, Grassau, Germany) and a standard FNA needle. Methods: We performed a prospective, multicenter randomized controlled study between June 2020 and September 2021, including patients with a solid pancreatic lesion referred for EUS-guided tissue sampling at 3 centers in Denmark. The patients were randomized 1:1 to either FNA needle or the novel FNB needle. Primary outcomes included the number of obtained tissue microcores and total and diagnostic tissue area. Results: Sixty-four patients were included. The median number of tissue microcores procured per pass was significantly higher in the FNB group compared with FNA (3 vs. 2, P < 0.001). Similarly, the mean total tissue area (2.74 vs. 0.44 mm2, P < 0.001) and mean diagnostic tissue area (1.74 vs. 0.28 mm2, P < 0.001) were more than 6-fold larger in the FNB samples compared with FNA. The median number of passes needed for a diagnostic sample was 1 for the FNB needle and 2 for FNA needle (P = 0.12). The novel FNB needle provided a higher percentage of samples of excellent quality (P = 0.002). Conclusions: The novel Franseen-type FNB needle seems to be significantly superior to a conventional FNA needle. The results of this study underline excellent performance of crown-cut needles.

Validation of a Novel EUS-FNB-Derived Organoid Co-Culture System for Drug Screening in Patients with Pancreatic Cancer.

Cancer-associated fibroblasts (CAFs) have been shown to impact the chemosensitivity of patient-derived tumor organoids (PDTOs). However, the published literature comparing PDTO response to clinical outcome does not include CAFs in the models. Here, a co-culture model was created using PDTOs and CAFs derived from endoscopic ultrasound-guided fine-needle biopsies (EUS-FNBs) for potential use in drug screening applications. Co-cultures were established, and growth was compared to monocultures using image metrics and a commercially available assay. We were able to establish and expand validated malignant PDTOs from 19.2% of adenocarcinomas from EUS-FNBs. CAFs could be established from 25% of the samples. The viability of PDTOs in the mixed cell co-culture could be isolated using image metrics. The addition of CAFs promoted PDTO growth in half of the established co-cultures. These results show that co-cultures can be established from tiny amounts of tissue provided by EUS-FNB. An increased growth of PDTOs was shown in co-cultures, suggesting that the present setup successfully models CAF-PDTO interaction. Furthermore, we demonstrated that standard validation techniques may be insufficient to detect contamination with normal cells in PDTO cultures established from primary tumor core biopsies.

Endoluminal radiofrequency ablation of malignant biliary obstruction.

This case report describes the first Danish case of endoluminal radiofrequency ablation (RFA) of malignant biliary obstruction due to a Klatskin tumour in a 59-year-old male undergoing neoadjuvant therapy. The treatment was interrupted several times due to recurrent occlusions of the bile duct stents. The patient was offered endoluminal RFA of the central bile ducts in order to reduce his tumour burden and possibly achieve longer stent patency, so the palliative therapy could be resumed. The procedure was performed successfully without any adverse events achieving access to previously occluded left hepatic duct.

Targeted next-generation sequencing of EUS-guided through-the-needle-biopsy sampling from pancreatic cystic lesions.

BACKGROUND AND AIMS: Recent advances have introduced molecular subtyping of pancreatic cystic lesions (PCLs) as a possible amendment to the diagnostic algorithm. The study evaluated the feasibility and diagnostic accuracy of molecular analysis and subtyping of PCLs using the recently introduced EUS-guided through-the-needle-biopsy (TTNB) sampling. METHODS: We prospectively included 101 patients in the study who presented with PCLs >15 mm in the largest cross-section. EUS-guided TTNB samples were obtained by a micro-biopsy forceps introduced through a 19-gauge needle. The TTNB samples were analyzed by next-generation sequencing (NGS) for point mutations in tumor suppressors and oncogenes using a 51-gene customized hotspot panel. Sensitivity and specificity were calculated with the histologic diagnosis as reference. RESULTS: After initial microscopic evaluation of the samples, 91 patients had residual TTNB samples available for NGS. Of these, 49 harbored mutations, most frequently in KRAS and GNAS, reflecting an excess frequency of intraductal papillary mucinous neoplasms (IPMNs) in the study population. A sensitivity and specificity of 83.7% (95% confidence interval [CI], 70.3-92.7) and 81.8% (95% CI, 48.2-97.7), respectively, were demonstrated for the diagnosis of a mucinous cyst and 87.2% (95% CI, 74.2-95.2) and 84.6% (95% CI, 54.5-98.1) for the diagnosis of an IPMN. CONCLUSIONS: Thus, molecular analysis of TTNB samples by NGS has high sensitivity and specificity for diagnosing mucinous cysts and IPMNs. Although the procedure comes with a risk of adverse events of 9.9%, TTNB samples are a robust alternative to cyst fluid for a combined histologic and molecular diagnosis of PCLs. (Clinical trial registration number: NCT03578445.).

Radiofrequency ablation of pancreatic insulinomas.

Insulinomas are rare neoplasms which may cause significant symptoms and substantially reduce quality of life. In operable patients, the current treatment is primarily surgery with either enucleation or resection of all or parts of the gland. This treatment is associated with high morbidity and long convalescence. Endoscopic ultrasound-guided radiofrequency ablation is a new and minimally invasive treatment for patients with insulinomas. The purpose of this review is to draw attention to the method and to communicate our preliminary experience with this procedure in Denmark.

Factors Associated with Polyp Detection Rate in European Colonoscopy Practice: Findings of The European Colonoscopy Quality Investigation (ECQI) Group.

Background: The European Colonoscopy Quality Investigation (ECQI) Group aims to raise awareness for improvement in colonoscopy standards across Europe. We analysed data collected on a sample of procedures conducted across Europe to evaluate the achievement of the polyp detection rate (PDR) target. We also investigated factors associated with PDR, in the hope of establishing areas that could lead to a quality improvement. Methods: 6445 form completions from 12 countries between 2 June 2016 and 30 April 2018 were considered for this analysis. We performed an exploratory analysis looking at PDR according to European Society of Gastrointestinal Endoscopy (ESGE) definition. Stepwise multivariable logistic regression analysis was conducted to determine the most influential associated factors after adjusting for the other pre-specified variables. Results: In our sample there were 3365 screening and diagnostic procedures performed in those over 50 years. The PDR was 40.5%, which is comparable with the ESGE minimum standard of 40%. The variables found to be associated with PDR were in descending order: use of high-definition equipment, body mass index (BMI), patient gender, age group, and the reason for the procedure. Use of HD equipment was associated with a significant increase in the reporting of flat lesions (14.3% vs. 5.7%, p < 0.0001) and protruded lesions (34.7% vs. 25.4%, p < 0.0001). Conclusions: On average, the sample of European practice captured by the ECQI survey meets the minimum PDR standard set by the ESGE. Our findings support the ESGE recommendation for routine use of HD colonoscopy.

Factors Associated with Withdrawal Time in European Colonoscopy Practice: Findings of the European Colonoscopy Quality Investigation (ECQI) Group.

The European Colonoscopy Quality Investigation (ECQI) Group aims to raise awareness for improvement in colonoscopy standards across Europe. We analyzed data collected on a sample of procedures conducted across Europe to evaluate the achievement of the European Society of Gastrointestinal Endoscopy (ESGE) mean withdrawal time (WT) target. We also investigated factors associated with WT, in the hope of establishing areas that could lead to a quality improvement. METHODS: 6445 form completions from 12 countries between 2 June 2016 and 30 April 2018 were considered for this analysis. We performed an exploratory analysis looking at WT according to the ESGE definition. Stepwise multivariable logistic regression analysis was conducted to determine the most influential associated factors after adjusting for the other pre-specified variables. RESULTS: In 1150 qualifying colonoscopies, the mean WT was 7.8 min. Stepwise analysis, including 587 procedures where all inputs were known, found that the variables most associated with mean WT were a previous total colonoscopy in the last five years (p = 0.0011) and the time of day the colonoscopy was performed (p = 0.0192). The main factor associated with a WT < 6 min was the time of day that a colonoscopy was performed. Use of sedation was the main factor associated with a higher proportion of WT > 10 min, along with a previous colonoscopy. CONCLUSIONS: On average, the sample of European practice captured by the ECQI survey met the minimum standard set by the ESGE. However, there was variation and potential for improvement.

Colonoscopy quality across Europe: a report of the European Colonoscopy Quality Investigation (ECQI) Group.

Background and study aims The European Colonoscopy Quality Investigation (ECQI) Group comprises expert colonoscopists and investigators with the aim of raising colonoscopy standards. We assessed the levels of monitoring and achievement of European Society of Gastrointestinal Endoscopy (ESGE) performance measures (PMs) across Europe using responses to the ECQI questionnaires. Methods The questionnaire comprises three forms: institution and practitioner questionnaires are completed once; a procedure questionnaire is completed on multiple occasions for individual total colonoscopies. ESGE PMs were approximated as closely as possible from the data collected via the procedure questionnaire. Procedure data could provide rate of adequate bowel preparation, cecal intubation rate (CIR), withdrawal time, polyp detection rate (PDR), and tattooing resection sites. Results We evaluated ECQI questionnaire data collected between June 2016 and April 2018, comprising 91 practitioner and 52 institution questionnaires. A total of 6445 completed procedure forms were received. Institution and practitioner responses indicate that routine recording of PMs is not widespread: adenoma detection rate (ADR) is routinely recorded in 29 % of institutions and by 34 % of practitioners; PDR by 42 % and 47 %, CIR by 62 % and 64 %, bowel preparation quality by 56 % and 76 %, respectively. Procedure data showed a rate of adequate bowel preparation of 84.2 %, CIR 73.4 %, PDR 40.5 %, mean withdrawal time 7.8 minutes and 12.2 % of procedures with possible removal of a non-pedunculated lesion ≥ 20 mm reporting tattooing. Conclusions Our findings clearly show areas in need of quality improvement and the importance of promoting quality monitoring throughout the colonoscopy procedure.

Clinical impact of endoscopic ultrasound-guided through-the-needle microbiopsy in patients with pancreatic cysts.

BACKGROUND: The limited data on the utility of endoscopic ultrasound (EUS)-guided through-the-needle biopsies (TTNBs) in patients with pancreatic cystic lesions (PCLs) originate mainly from retrospective studies. Our aim was to determine the clinical impact of TTNBs, their added diagnostic value, and the adverse event rate in a prospective setting. METHODS: This was a prospective, single-center, open-label controlled study. Between February 2018 and August 2019, consecutive patients presenting with a PCL of 15 mm or more and referred for EUS were included. Primary outcome was a change in clinical management of PCLs following TTNB compared with cross-sectional imaging and cytology. Adverse events were defined according to the ASGE lexicon. RESULTS: 101 patients were included. TTNBs led to a change in clinical management in 11.9 % of cases (n = 12). Of these, 10 had serous cysts and surveillance was discontinued, while one of the remaining two cases underwent surgery following diagnosis of a mucinous cystic neoplasm. The diagnostic yield of TTNBs for a specific cyst diagnosis was higher compared with FNA cytology (69.3 % vs. 20.8 %, respectively; P < 0.001). The adverse event rate was 9.9 % (n = 10; 95 % confidence interval 5.4 % - 17.3 %), with the most common event being acute pancreatitis (n = 9). Four of the observed adverse events were severe, including one fatal outcome. CONCLUSIONS: TTNBs resulted in a change of clinical management in about one in every 10 patients; however, the associated adverse event risk was substantial. Further studies are warranted to elucidate in which subgroups of patients the clinical benefit outweighs the risks.

EUS-guided through-the-needle microbiopsy of pancreatic cysts: Technical aspects (with video).

Pancreatic cystic lesions are frequently encountered and diagnostically challenging as some of the cysts may have malignant potential (mucinous) while others are completely benign (serous). EUS-guided through-the-needle biopsy (EUS-TTNB) of the cyst wall has recently been introduced as an alternative to cyst fluid cytology. Several studies have shown that microbiopsies outperform cytology in terms of distinction between mucinous and nonmucinous lesions, but also in determining the specific cyst diagnosis. However, little is known about the technical aspects of tissue sampling with TTNB. Herein, we summarize our experience with the procedure in a tertiary referral center and discuss indications, technical aspects, and safety of the procedure. Most adverse events (AEs) associated with the procedure are mild, but there is emerging evidence that the rate of postprocedural pancreatitis is higher compared to standard fine-needle aspiration. The added diagnostic yield should therefore be placed in perspective with an increased risk of AEs. Prospective studies are warranted to fully identify which patient groups could benefit from EUS-TTNB.

Automatic and unbiased assessment of competence in colonoscopy: exploring validity of the Colonoscopy Progression Score (CoPS).

Background and aims: Colonoscopy is a difficult procedure to master. Increasing demands for colonoscopy, due to screening and surveillance programs, have highlighted the need for competent performers. Valid methods for assessing technical skills are pivotal for training and assessment. This study is the first clinical descriptive report of a novel colonoscopy assessment tool based on Magnetic Endoscopic Imaging (MEI) data and the aim was to gather validity evidence based on the data collected using the "Colonoscopy Progression Score" (CoPS). Methods: We recorded 137 colonoscopy procedures performed by 31 endoscopists at three university hospitals. The participants performed more than two procedures each (range 2 - 12) and had an experience of 0 - 10 000 colonoscopies. The CoPS was calculated for each recording and validity was explored using a widely accepted contemporary framework. The following sources of validity evidence were explored: response process (data collection), internal structure (reliability), relationship to other variables (i. e. operator experience), and consequences of testing (pass/fail). Results: Identical set-ups at all three locations ensured uniform data collection. The Generalizability coefficient (G-coefficient) was 0.80, and a Decision-study (D-study) revealed that four recordings were sufficient to ensure a G-coefficient above 0.80. We showed a positive correlation between CoPS and experience with Pearson's r of 0.61 (P < 0.001). A pass/fail standard of 107 points was established using the contrasting group method to explore the consequences of testing. Conclusion: This study provides evidence supporting the validity of the CoPS for use in assessing technical colonoscopy performance in the clinical setting. STUDY REGISTRATION: NCT01997177.

[CT-colonography after incomplete conventional colonoscopy]. / Computertomografisk kolografi ved inkomplet koloskopi.

INTRODUCTION: CT-colonography (CTC) is recommended in the case of an incomplete conventional colonoscopy (CC). The present study was initiated to assess feasibility and outcomes in same-day CTC after incomplete CC. MATERIALS AND METHODS: Out of 480 consecutive patients who had CC for symptoms or for surveillance, 50 were incomplete for reasons other than insufficient preparation. If possible, CTC was performed on the same day in dual positions without contrast. Where CTC found suspected polyps, patients had a re-CC for verification and removal, and subsequent surgery in the case of cancer. RESULTS: Reasons for incomplete CC were loop formation (24%), pain (48%), kinking or external compression (24%) or benign strictures (4%). 43 of 50 CTCs (86%, 95% CI 73-94%) were conclusive. The organization allowed for 25 patients (50%) to have CTC on the same day. CTC detected 17 suspected polyps/masses, 13 of which were verified in 12 patients (28%). Re-CC or surgery verified 3 out of 4 of the suspected polyps < or = 5 mm, 5 out of 6 of those sized 6-9 mm, and 5 out of 7 of the masses > 9 mm (including 2 cancers). 19 (38%) had previously undetected extra-intestinal disease, including metastases in 4 patients, a uterine cancer in one, and a 7 cm abdominal aortic aneurism in one. CONCLUSION: Same-day CTC after incomplete CC is feasible and effective.

[Laparoscopy-assisted colon resection. A prospective study with short-term results and 12-38 months' follow-up]. / Laparoskopisk assisteret colonkirurgi. En prospektiv opgorelse af tidlige resultater og 12-38 maneders followuptid.

INTRODUCTION: Despite several reports demonstrating its clinical benefits, laparoscopy-assisted colectomy (LAC) has not gained universal acceptance because of its oncologic implications. In this article we present our experiences with LAC. MATERIALS AND METHODS: A consecutive series of 75 patients undergoing LAC between February 2001 and March 2003 was followed. Fifty-nine of the patients had colon cancer. Standardized postoperative care procedures were used. The median follow-up time for the colon cancer patients was 19 months (range 12-38 months). RESULTS: The median operation time was 190 minutes (range 150-300 minutes). Two patients (3%) required a conversion to laparotomy. Ten patients (13%) suffered from postoperative complications. The postoperative mortality rate was 3%. The median length of stay for the patients who were directly discharged to their home was 4 days (range 1-30 days). There were no readmissions in the postoperative period. Fifty-five patients with malignancy underwent curative resection, while four, who had metastatic disease, were operated on for palliation. The frequency of recurrence and the cancer-related mortality rate in the follow-up period were both 21%. No significant differences were found between patients with Dukes' type B and type C with regard to being free of recurrence or cancer-related survival. One port-site recurrence (2%) occurred in the patients who underwent curative resection. DISCUSSION: Our results shows that LAS has clinical advantages, especially in the short term, and provides better oncologic results than open surgery, especially in cases of Dukes' type C cancer. LAC for cancer should be performed by experienced hands and monitored adequately by a national register to ensure satisfactory oncologic outcomes.

[Laparoscopic colon resection in the treatment of total colonic obstruction following endoscopic stenting in elderly patients]. / Laparoskopisk colonresektion til behandling af total colonobstruktion forudgået af stentanlaeggelse på aeldre patienter.

Two cases of elderly patients who presented with total colonic obstruction are discussed. We performed elective laparoscopic one-stage colonic resection following emergency endoscopic stenting. The patients were discharged six and seven days after operation without any complications. One year follow-up showed no signs of recurrence.