Shyam Varadarajulu

For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines.

Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. In this single blind multicenter randomized trial we observed that In patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention… Show more

Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. In this single blind multicenter randomized trial we observed that In patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success. Show less

As clinically actionable genomic lesions are found in almost 30% of pancreatic cancers that can potentially impact management, there has been increased focus on molecular profiling. Although tissue acquisition under endoscopic ultrasound (EUS) guidance is an established diagnostic method, procedural outcomes for comprehensive molecular profiling (CMP) have been variable. In a randomised trial, we found that performing two dedicated passes using the 22-gauge Franseen needle, adopting the fanning… Show more

As clinically actionable genomic lesions are found in almost 30% of pancreatic cancers that can potentially impact management, there has been increased focus on molecular profiling. Although tissue acquisition under endoscopic ultrasound (EUS) guidance is an established diagnostic method, procedural outcomes for comprehensive molecular profiling (CMP) have been variable. In a randomised trial, we found that performing two dedicated passes using the 22-gauge Franseen needle, adopting the fanning and stylet-retraction manoeuvres, yielded optimum specimen from which adequate RNA and DNA could be extracted for CMP in almost 95% of patients with pancreatic cancer. Show less

Although liver biopsies (LBs) are being increasingly performed under endoscopic ultrasound (EUS) guidance, there are limited data comparing outcomes with current standard-of-care, transabdominal ultrasound (US)-guided percutaneous (PC) methods. In a randomised trial, we observed that the PC, US-guided method yielded significantly more optimal specimens, defined as specimen length of 25 mm or greater and presence of at least 11 complete portal tracts, compared with the EUS-guided method (57.9%… Show more

Although liver biopsies (LBs) are being increasingly performed under endoscopic ultrasound (EUS) guidance, there are limited data comparing outcomes with current standard-of-care, transabdominal ultrasound (US)-guided percutaneous (PC) methods. In a randomised trial, we observed that the PC, US-guided method yielded significantly more optimal specimens, defined as specimen length of 25 mm or greater and presence of at least 11 complete portal tracts, compared with the EUS-guided method (57.9% vs 23.8%, p=0.028). Also, the PC method resulted in worse initial postprocedural pain but was less costly (US$1824 vs US$3240, p<0.001). Show less

In this first published randomized trial, given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.

Trial registration number: Clinicaltrials.gov number: NCT04143698.

In patients with suspected pancreatic cancer, samples with the highest degree of cellularity in a single biopsy, resulting in a diagnostic accuracy of 90% or higher, were collected by fine-needle biopsy using the franseen or fork-tip needle. Clinicaltrials.gov no: NCT04085055.

In a randomized trial of patients with difficult bile stones that cannot be cleared by standard maneuvers, SOC-guided lithotripsy leads to duct clearance in a significantly higher proportion of patients than large balloon sphincteroplasty particularly when stone size exceeds the diameter of the extrahepatic bile duct. Adjunct lithotripsy might be required in patients with tapered distal bile duct, because LBS alone is less likely to be successful. ClinicalTrials.gov no: NCT00852072.

In this first published randomized trial, we found that centers without onsite cytopathology support that analyze 3 single-operator cholangioscopy-guided biopsies of a biliary stricture and process the specimens offsite can establish the correct diagnosis in 90% of cases. ClinicalTrials.gov, Number: NCT01815619.

In this first published randomized trial, except for procedure duration, there was no significant difference in treatment outcomes between LAMS and plastic stents. To minimise adverse events with LAMS, patients should undergo follow-up imaging and stent removal at 3 weeks if walled-off necrosis has resolved.
Trial registration number: NCT02685865.

In this first randomized trial conducted outside of the Netherlands, it was found that an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537

In this first published trial, compared with EUS-CPN, EUS-RFA provided more pain relief and improved the quality of life for patients with pancreatic cancer. (Clinical trials registration number: NCT03152487.).

As cytological aspirates from endoscopic-ultrasound-guided fine needle aspiration (EUS-FNA) has limited diagnostic sensitivity and are suboptimal for molecular profiling and morphological characterisation of certain neoplasms, a fine needle biopsy (FNB) with three-pronged (Franseen geometry) cutting edge has been developed to procure histology. In a randomised trial of 46 patients with pancreatic masses, procurement of histological core tissue as evidenced by total tissue and tumour areas was… Show more

As cytological aspirates from endoscopic-ultrasound-guided fine needle aspiration (EUS-FNA) has limited diagnostic sensitivity and are suboptimal for molecular profiling and morphological characterisation of certain neoplasms, a fine needle biopsy (FNB) with three-pronged (Franseen geometry) cutting edge has been developed to procure histology. In a randomised trial of 46 patients with pancreatic masses, procurement of histological core tissue as evidenced by total tissue and tumour areas was significantly higher for 22G FNB than FNA needle. Also, retention of tissue architecture and presence of desmoplastic fibrosis, which are critical for ancillary testing and molecular profiling, respectively, were significantly higher for FNB. Show less

In a randomized trial of patients undergoing EUS-FNA for pancreatic masses, samples collected with 22-gauge vs 25-gauge needles performed equally well for offsite specimen evaluation. Use of suction appears to increase number of passes needed and specimen bloodiness. Specimen collection techniques should be individualized based on method of evaluation. ClinicalTrials.gov no: NCT02424838.

In this first published randomized trial, given the similar rates of adverse events and treatment outcomes, EUS-BD is a practical alternative to ERCP for primary biliary decompression in pancreatic cancer. (Clinical trial registration number: NCT03054987.).

In this first published randomized trial, there was no significant difference between Franseen and Fork-tip needles in yielding histologic tissue. Given their ability to yield diagnostic cell block in greater than 90% of patients, the new-generation fine-needle biopsy needles may obviate the need for ROSE. (Clinical trial registration number: NCT02910960.)

The 25-gauge FNA needle yielded a diagnostic cell block in only 81% of patients, irrespective of whether 2 or 4 FNA passes were performed. These findings have important implications for centers without on-site cytopathology services. (Clinical trial registration number NCT01809028.).

In this first published randomized trial comparing endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage, none of the patients in the endoscopy group had pseudocyst recurrence during the follow-up period, therefore there is no evidence that surgical cystogastrostomy is superior. However, endoscopic treatment was associated with shorter hospital stays, better physical and mental health of patients, and lower cost. Trial Registration: ClinicalTrials.gov: NCT00826501.

In this first published randomized trial, fanning technique of FNA was superior to the standard approach because fewer passes were required to establish the diagnosis. If these promising data are confirmed by other investigators, consideration should be given to incorporating the fanning technique into routine practice of EUS - FNA. Registered at Clinical Trials.gov (NCT 01501903).

In this first randomized trial that compared FNA and FNB (ProCore) needles at EUS, the diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles were comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types. (Clinical trial registration number: NCT01394159.)

In this first randomized trial comparing EUS and EGD, it was shown that when available, EUS should be considered as the first-line treatment modality for endoscopic drainage of pancreatic pseudocysts given its high technical success rate.

Ketamine is a useful adjunct to conscious sedation in patients who are difficult to sedate. Its use Results in better quality and depth of sedation with shorter recovery times than patients sedated using benzodiazepines and meperidine alone. Further prospective studies evaluating the effectiveness and safety of ketamine for endoscopic sedation are needed.

In this first published randomized trial, pancreatic sphincterotomy was safer in high-risk patients when performed with a needle knife over a pancreatic stent when compared to using a pull papillotome.

In this first published randomized trial, dextrose 50 % is superior to normal saline as a submucosal fluid cushion, as it allows better en bloc resection during injection-associated polypectomy.