Per-oral pancreatoscopy-guided lithotripsy vs. extracorporeal shock wave lithotripsy for treating refractory main pancreatic duct stones in chronic pancreatitis: Protocol for an open-label multi-center randomized clinical trial.

BACKGROUNDS/OBJECTIVES: Patients with chronic pancreatitis may develop pancreatic duct stones that can obstruct outflow leading to ductal hypertension and pain. Both endoscopic retrograde pancreatography (ERP) with per-oral pancreatoscopy (POP) and intraductal lithotripsy and extracorporeal shock wave lithotripsy (ESWL) are feasible options to attempt ductal stone clearance. This study aims to compare POP-guided lithotripsy with ESWL in the management of refractory symptomatic main pancreatic duct stones. METHODS: This is an open-label, multi-center, parallel, randomized clinical trial. Patients with chronic pancreatitis and main pancreatic duct stones ≥5 mm who fail standard ERP methods for stone removal will be eligible for this study. In total, 150 subjects will be randomized 1:1 to either ESWL or POP. A maximum of 4 sessions of either ESWL or POP will be allowed in each arm, with crossover permitted thereafter. The primary outcome is complete stone clearance and secondary outcomes include quality of life, pain scores, number of interventions, and daily opiate requirements. CONCLUSIONS: This study aims to answer the question of which lithotripsy method is superior in removing refractory pancreatic duct stones while addressing the effects of lithotripsy on quality of life and pain in patients with chronic calcific pancreatitis (ClinicalTrials.gov NCT04115826).

Does a slower treatment rate impact the efficacy of extracorporeal shock wave lithotripsy for solitary kidney or ureteral stones?

PURPOSE: We compared the efficacy of an SR (70 to 80 shocks per minute) and an FR (120 shocks per minute) for ESWL for solitary stones less than 2 cm located in the kidney or proximal ureter. MATERIALS AND METHODS: A total of 349 patients with a solitary, radiopaque kidney or ureteral stone underwent ESWL on a DoLi(R) 50 lithotriptor. Patients were grouped based on stone size, stone location and whether SR or FR treatment was performed. Of the 349 patients 135 had a renal stone between 1and 2 cm, 137 had a renal stone less than 1 cm and 77 had a proximal ureteral stone with a surface area of between 30 and 90 mm. SFRs were determined at approximately 1 month by plain x-ray of the kidneys, ureters and bladder. RESULTS: In comparison to the FR groups SR groups required fewer shocks and had significantly lower power indexes. Of patients with renal stones between 1 and 2 cm 24 of 52 (46%) in the FR group were stone-free compared to 56 of 83 (67%) in the SR group (p <0.05). For stones with a surface area of 30 to 90 mm located in the kidney or proximal ureter there was a trend toward an improved SFR in the SR group but differences between the SR and FR groups were not statistically significant. CONCLUSIONS: For solitary renal stones between 1 and 2 cm an SR results in a better treatment outcome than an FR for ESWL. However, when stone size is less than 1 cm, SFR differences in the SR and FR treatment groups become less significant.

Is stone radiodensity a useful parameter for predicting outcome of extracorporeal shockwave lithotripsy for stones < or = 2 cm?

PURPOSE: Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. It has been suggested that stone radiodensity, as determined either by plain radiography or computed tomography attenuation values, may be an independent predictor of SWL success. We examined the outcome of SWL for solitary stones less than or equal to 2 cm located within the renal pelvis, based on their radiodensity. MATERIAL AND METHODS: 211 patients with solitary renal pelvic stones measuring less than or equal to 2 cm were treated on a Dornier Doli 50 lithotriptor under general anesthesia. The radiodensity of the stone was determined to be either less than, equal to, or greater than the radiodensity of the ipsilateral 12th rib. Stone-free rates (SFR) were determined at 3 months by kidney, ureters and bladder (KUB) plain X-rays. Patients requiring re-treatment or auxiliary procedures were considered failures of SWL. RESULTS: Follow-up SFR information was available in all 211 patients. Stone composition was available in 158 (75%) treated patients, but no correlation was found between stone radiodensity and stone composition. For stones < or = 10 mm within the renal pelvis, the SFRs were similar (71 to 74% regardless of stone radiodensity). For stones between 11 and 20 mm, the SFR was 60% if the stone had a radiodensity > 12th rib compared to a SFR of 71% if the stone radiodensity was < or = 12th rib. However, these differences in SFRs were not statistically significant. CONCLUSIONS: On the Doli machine, stone radiodensity alone does not predict lithotripsy treatment outcome for stones < or = 1 cm within the renal pelvis. This parameter is probably only useful as the stone size becomes larger than 1 cm, and should be used in conjunction with other stone parameters to select appropriate therapy.

Is stone radiodensity a useful parameter for predicting outcome of extracorporeal shockwave lithotripsy for stones <= 2 cm?

PURPOSE: Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. It has been suggested that stone radiodensity, as determined either by plain radiography or computed tomography attenuation values, may be an independent predictor of SWL success. We examined the outcome of SWL for solitary stones less than or equal to 2 cm located within the renal pelvis, based on their radiodensity. MATERIALS AND METHODS: 211 patients with solitary renal pelvic stones measuring less than or equal to 2 cm were treated on a Dornier Doli 50 lithotriptor under general anesthesia. The radiodensity of the stone was determined to be either less than, equal to, or greater than the radiodensity of the ipsilateral 12th rib. Stone-free rates (SFR) were determined at 3 months by kidney, ureters and bladder (KUB) plain X-rays. Patients requiring re-treatment or auxiliary procedures were considered failures of SWL. RESULTS: Follow-up SFR information was available in all 211 patients. Stone composition was available in 158 (75 percent) treated patients, but no correlation was found between stone radiodensity and stone composition. For stones <= 10 mm within the renal pelvis, the SFRs were similar (71 to 74 percent regardless of stone radiodensity). For stones between 11 and 20 mm, the SFR was 60 percent if the stone had a radiodensity > 12th rib compared to a SFR of 71 percent if the stone radiodensity was <= 12th rib. However, these differences in SFRs were not statistically significant. CONCLUSIONS: On the Doli machine, stone radiodensity alone does not predict lithotripsy treatment outcome for stones <= 1 cm within the renal pelvis. This parameter is probably only useful as the stone size becomes larger than 1 cm, and should be used in conjunction with other stone parameters to select appropriate therapy.