Cold Versus Hot Snare Endoscopic Resection of Large Nonpedunculated Colorectal Polyps: Randomized Controlled German CHRONICLE Trial.

BACKGROUND & AIMS: Endoscopic mucosal resection (EMR) is standard therapy for nonpedunculated colorectal polyps ≥20 mm. It has been suggested recently that polyp resection without current (cold resection) may be superior to the standard technique using cutting/coagulation current (hot resection) by reducing adverse events (AEs), but evidence from a randomized trial is missing. METHODS: In this randomized controlled multicentric trial involving 19 centers, nonpedunculated colorectal polyps ≥20 mm were randomly assigned to cold or hot EMR. The primary outcome was major AE (eg, perforation or postendoscopic bleeding). Among secondary outcomes, major AE subcategories, postpolypectomy syndrome, and residual adenoma were most relevant. RESULTS: Between 2021 and 2023, there were 396 polyps in 363 patients (48.2% were female) enrolled for the intention-to-treat analysis. Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001; odds ratio [OR], 0.12; 95% CI, 0.03-0.54). Rates for perforation and postendoscopic bleeding were significantly lower in the cold group, with 0% vs 3.9% (P = .007) and 1.0% vs 4.4% (P = .040). Postpolypectomy syndrome occurred with similar frequency (3.1% vs 4.4%; P = .490). After cold resection, residual adenoma was found more frequently, with 23.7% vs 13.8% (P = .020; OR, 1.94; 95% CI, 1.12-3.38). In multivariable analysis, lesion diameter of ≥4 cm was an independent predictor both for major AEs (OR, 3.37) and residual adenoma (OR, 2.47) and high-grade dysplasia/cancer for residual adenoma (OR, 2.92). CONCLUSIONS: Cold resection of large, nonpedunculated colorectal polyps appears to be considerably safer than hot EMR; however, at the cost of a higher residual adenoma rate. Further studies have to confirm to what extent polyp size and histology can determine an individualized approach. German Clinical Trials Registry (Deutsches Register Klinischer Studien), Number DRKS00025170.

Comparison between traumatic and atraumatic over-the-scope clips in patients with duodenal ulcer bleeding: a retrospective analysis with propensity score-based matching.

BACKGROUND AND AIMS: Over-the-scope clips (OTSCs) substantially improved the endoscopic armamentarium for the treatment of severe GI bleeding and can potentially overcome limitations of standard clips. Data indicate a superiority of OTSCs in hemostasis as first- and second-line therapy. However, the impact of the OTSC designs, in particular the traumatic (-t) or atraumatic (-a) type, in duodenal ulcer bleeding has not been analyzed so far. METHODS: This was a retrospective analysis of a prospective collected database from 2009 to 2020 of 6 German endoscopic centers. All patients who underwent emergency endoscopy and were treated using an OTSC for duodenal ulcer bleeding were included. OTSC-t and OTSC-a patients were compared by the Fisher exact test, χ2 test, or Mann-Whitney U test as appropriate. A propensity score-based 1:1 matching was performed to obtain equal distribution of baseline characteristics in both groups. RESULTS: The entire cohort comprised 173 patients (93 OTSC-a, 80 OTSC-t). Age, gender, anticoagulant therapy, Rockall score, and treatment regimen had similar distributions in the 2 groups. However, the OTSC-t group showed significantly more active bleeding ulcers (Forrest Ia/b). Matching identified 132 patients (66 in both groups) with comparable baseline characteristics. Initial bleeding hemostasis (OTSC-a, 90.9%; OTSC-t, 87.9%; P = .82) and 72-hour mortality (OTSC-a, 4.5%; OTSC-t, 6.0%; P > .99) were not significantly different, but the OTSC-t group revealed a clearly higher rate of recurrent bleeding (34.9% vs 7.6%, P < .001) and necessity of red blood cell transfusions (5.1 ± 3.4 vs 2.5 ± 2.4 concentrates, P < .001). CONCLUSIONS: For OTSC use, the OTSC-a should be the preferred option for duodenal ulcer bleeding.

PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study.

BACKGROUND: A recently developed haemostatic peptide gel for endoscopic application has been introduced to improve the management of gastrointestinal bleeding. The aim of this pilot study was to evaluate the feasibility, safety, efficacy and indication profiles of PuraStat in a clinical setting. METHODS: In this prospective observational multicentre pilot study, patients with acute non-variceal gastrointestinal bleeding (upper and lower) were included. Primary and secondary application of PuraStat was evaluated. Haemoglobin, prothrombin time, platelets and transfusion behaviour were documented before and after haemostasis. The efficacy of PuraStat was assessed during the procedure, at 3 days and 1 week after application. RESULTS: 111 patients with acute gastrointestinal bleeding were recruited into the study. 70 percent (78/111) of the patients had upper gastrointestinal bleeding and 30% (33/111) had lower gastrointestinal bleeding. After primary application of PuraStat, initial haemostatic success was achieved in 94% of patients (74/79, 95% CI 88-99%), and in 75% of the patients when used as a secondary haemostatic product, following failure of established techniques (24/32, 95% CI 59-91%). The therapeutic success rates (absence of rebleeding) after 3 and 7 days were 91% and 87% after primary use, and 87% and 81% in all study patients. Overall rebleeding rate at 30 day follow-up was 16% (18/111). In the 5 patients who finally required surgery (4.5%), PuraStat allowed temporary haemostasis and stabilisation. CONCLUSIONS: PuraStat expanded the therapeutic toolbox available for an effective treatment of gastrointestinal bleeding sources. It could be safely applied and administered without complications as a primary or secondary therapy. PuraStat may additionally serve as a bridge to surgery in order to achieve temporary haemostasis in case of refractory severe bleeding, possibly playing a role in preventing immediate emergency surgery.

Over-the-scope-grasper: A new tool for pancreatic necrosectomy and beyond - first multicenter experience.

BACKGROUND: Endoscopic treatment of pancreatic necrosis can be challenging and time-consuming because sticky necrotic debris is sometimes difficult to remove. The over-the-scope-grasper, a new tool that has recently become available for this purpose, might also be useful for other indications. However, clinical data on the efficacy and safety of this new device are lacking. AIM: To evaluate the technical success and safety of the device in a multicenter setting. METHODS: The over-the-scope-grasper was used in nine selected endoscopic centers between November 2020 and October 2021 for appropriate indications. Overall, 56 procedures were included in the study. We retrospectively evaluated procedural parameters of all endoscopic interventions using a predefined questionnaire, with special respect to technical success, indications, duration of intervention, type of sedation, and complications. In the case of pancreatic necrosectomy, the access route, stent type, number of necrosis pieces removed, and clinical handling were also recorded. RESULTS: A total of 56 procedures were performed, with an overall technical success rate of 98%. Most of the procedures were endoscopic pancreatic necrosectomies (33 transgastric, 4 transduodenal). In 70% of the procedures, access to the necrotic cavity was established with a lumen apposing metal stent. The technical success of pancreatic necrosectomy was 97%, with a mean of 8 pieces (range, 2-25 pieces) of necrosis removed in a mean procedure time of 59 min (range, 15-120 min). In addition, the device has been used to remove blood clots (n = 6), to clear insufficiency cavities before endoluminal vacuum therapy (n = 5), and to remove foreign bodies from the upper gastrointestinal tract (n = 8). In these cases, the technical success rate was 100%. No moderate or severe/fatal complications were reported in any of the 56 procedures. CONCLUSION: These first multicenter data demonstrate that the over-the-scope-grasper is a promising device for endoscopic pancreatic necrosectomy, which is also appropriate for removing foreign bodies and blood clots, or cleaning insufficiency cavities prior to endoluminal vacuum therapy.

Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel disorders.

OBJECTIVES: Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods. METHODS: The study included 100 patients (50 in each group; 63 men, 37 women; mean age 55 years), with no previous small-bowel or colon surgery. The indications for enteroscopy were (suspected) mid-gastrointestinal bleeding, Crohn's disease, small-bowel masses, chronic diarrhea or abdominal pain or both, and other conditions. Fujinon instruments were used, with either two balloons or one. The end point of the study was complete enteroscopy as the most objective parameter. RESULTS: No severe complications such as perforation, bleeding, or pancreatitis occurred. Instrument preparation time was significantly faster with SBE than with DBE (P<0.0001). Complete enteroscopy was achieved with the DBE technique in 66% of cases (33 patients), either with the oral route alone or with combined oral and anal approaches. With the SBE technique, the complete enteroscopy rate was significantly lower at 22% (P<0.0001; 11 patients, only with oral and anal routes combined). The rate of therapeutic consequences for the patients based on diagnostic yield and negative complete enteroscopy was significantly higher (P=0.025) in the DBE group at 72%, compared with 48% in the SBE group. CONCLUSIONS: The complete enteroscopy rate was three times higher with DBE than with SBE, accompanied by a higher diagnostic yield. DBE must therefore continue to be regarded as the nonsurgical gold standard procedure for deep small-bowel endoscopy.

Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses.

BACKGROUND: The use of 19-gauge (G) stainless steel needles for endoscopic ultrasound-guided fine-needle biopsy of a pancreatic mass often results in technical difficulties due to an inability to advance the relatively rigid needle out of the endoscope. More flexible nitinol-based needles might decrease such technical difficulties and thus increase diagnostic accuracy. OBJECTIVE: In this prospective multicenter randomized single-blinded study we compared the diagnostic value of those two needle types in patients with a solid pancreatic lesion. METHODS: Patients with a solid pancreatic mass were diagnosed with endoscopic ultrasound-guided fine-needle biopsy using one puncture with each needle in a randomized fashion. The primary endpoint was the diagnostic accuracy of each needle. Secondary endpoints included time for puncture, amount of tumour tissue obtained, and technical failure. Histological specimens were centrally reviewed by a pathologist blinded to the final needle type and final diagnosis (ClinicalTrials.gov Identifier: NCT02909530). RESULTS: Out of 46 prospectively recruited patients, central pathological examination was available for 41. Diagnostic accuracy for the two needles combined was 87.8%. Diagnostic accuracy was 66% and 68% using the stainless steel- and nitinol-based needle respectively. Time spent for puncturing was 137 ± 61 s (mean ± standard deviation) for the stainless steel and 111 ± 53 s for the nitinol-based needle (p = 0.037). Technical failure occurred in three (6.5%) cases using the stainless steel- and in none using the nitinol-based needle. CONCLUSIONS: Usage of a nitinol-based 19-G needle failed to present a significant superior accuracy compared with a stainless steel needle in endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions.

Software Tools in Endoscopy - Nice to Have or Essential?

BACKGROUND: Documentation of findings and of the treatment implications resulting from them is one of the central tasks involved in medical work. The introduction of software tools for managing and providing technical support for this task is a logical development. METHODS: A literature search was conducted in September 2015 using PubMed and the search terms 'gastrointestinal endoscopy AND electronic documentation' and 'software tools AND gastrointestinal endoscopy AND documentation'. RESULTS: The requirements in relation to documentation, patient information and sedation, dealing with histological findings, materials logistics, recording video documents, and hygiene documentation are discussed. CONCLUSION: Software tools are essential for managing basic documentation requirements. However, for many aspects of the documentation required in a modern endoscopy department, there are various - and sometimes substantial - gaps in the programs currently available. More intensive discussions need to take place regarding existing gaps and requirements, both with the suppliers concerned and among colleagues and specialist societies.

Endoscopic vacuum therapy for esophageal perforations and leakages.

BACKGROUND AND STUDY AIMS: Injuries to the esophageal wall, such as perforations and anastomotic leaks, are serious complications of surgical and endoscopic interventions. Since 2006, a new treatment has been introduced, in the form of endoscopically placed vacuum sponge therapy. PATIENTS AND METHODS: Between April 2012 and October 2014, 10 patients (5 men and 5 women) aged 57 to 94 years were treated at our institution using endoscopic vacuum therapy (EVT) in the upper gastrointestinal tract. RESULTS: The defect in the esophageal wall was successfully closed in seven of the 10 patients (70 %). No severe complications occurred. CONCLUSIONS: EVT is a valuable tool for management of defects in the esophageal wall and should be considered as a treatment option for patients with this condition.

Chromoendoscopy is a valuable tool for screening of high-risk patients with head and neck cancer for early detection of esophageal cancer.

BACKGROUND: The incidence of esophageal cancer is markedly increased in patients with head and neck cancer, and the presence of esophageal cancer is associated with reduced survival rates. AIMS: We investigated whether the results of screening for esophageal cancer in patients with head and neck cancer using chromoendoscopy would change the treatment of such patients. PATIENTS: 87 patients with head and neck cancer and known alcohol or nicotine abuse were screened for esophageal cancer. METHODS: The patients underwent esophagogastroduodenoscopy and staining of the esophagus with 2% Lugol's solution. Biopsies were taken from unstained areas for histopathological assessment. RESULTS: Esophageal cancer was newly diagnosed in 10 patients (11.5%), including 2 with carcinoma in situ. There were dysplastic changes in 6 patients (7%) and an unknown Barrett esophagus in 4 patients (5%). In 36 patients (41%) unstained areas were associated with esophagitis. While unstained areas could not be detected in 17 patients, the histology was normal in 14 patients with unstained areas. In all the patients with newly detected invasive esophageal cancer, the treatment had to be changed from a curative neoadjuvant approach to palliative treatment. In 2 patients with carcinoma in situ mucosectomy was performed. In the cases with dysplastic areas and newly detected Barrett epithelium a careful follow-up regime was arranged. CONCLUSIONS: The staging of patients with head and neck cancer, and the risk factors for esophageal cancer should include chromoendoscopy of the esophagus as a standard procedure. Extended staging provides critical additional information, which helps to more safely distinguish future candidates for curative and palliative treatment.