Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A Sham-Controlled, Randomized Trial.

BACKGROUND: No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis. OBJECTIVE: To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones. DESIGN: 24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781). SETTING: Asian Institute of Gastroenterology in India from February 2021 to July 2022. PARTICIPANTS: 106 patients with chronic pancreatitis. INTERVENTION: Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures. MEASUREMENTS: The primary end point was pain relief on a 0- to 10-point visual analog scale (VAS) at 12 weeks. Secondary outcomes were assessed after 12 and 24 weeks and included 30% pain relief, opioid use, pain-free days, questionaries, and complications to interventions. RESULTS: 52 patients in the ESWL/ERP group and 54 in the sham group were included. At 12 weeks, the ESWL/ERP group showed better pain relief compared with the sham group (mean difference in change, -0.7 [95% CI, -1.3 to 0] on the VAS; P = 0.039). The difference between groups was not sustained at the 24-week follow-up, and no differences were seen for 30% pain relief at 12- or 24-week follow-up. The number of pain-free days was increased (median difference, 16.2 days [CI, 3.9 to 28.5 days]), and the number of days using opioids was reduced (median difference, -5.4 days [CI, -9.9 to -0.9 days]) in the ESWL/ERP group compared with the sham group at 12-week follow-up. Safety outcomes were similar between groups. LIMITATION: Single-center study and limited duration of follow-up. CONCLUSION: In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief. PRIMARY FUNDING SOURCE: Asian Institute of Gastroenterology and Aalborg University Hospital.

Predictors of persistent pain after extracorporeal shockwave lithotripsy for painful chronic calcific pancreatitis.

BACKGROUND: Extracorporeal shockwave lithotripsy (ESWL) and/or endoscopic retrograde cholangiopancreatography (ERCP) are recommended as first-line therapy for painful uncomplicated chronic pancreatitis with obstructed main pancreatic duct (MPD) in the pancreas head/body. However, predictors of pain relief after ESWL are unknown. We evaluated independent predictors of persistent pain in patients who underwent ESWL for chronic pancreatitis. METHODS: 640 consecutive adult patients with chronic pancreatitis, who underwent successful ESWL with ERCP and pancreatic duct (PD) stent placement, were followed for 12 months. The pain was assessed at baseline and at 12 months using the Izbicki Pain Score, with a score decrease of >50% considered pain relief. Independent predictors of pain relief were derived from logistic regression analysis. RESULTS: Of 640 patients (mean age 36.71 [SD 12.19] years; 60.5% men), 436 (68.1%) had pain relief and 204 (31.9%) had persistent pain. On univariate analysis, older age, male sex, alcohol and tobacco intake, longer duration of symptoms, dilated MPD and MPD stricture were associated with persistent pain at 12 months (P<0.05). Consumption of alcohol (odds ratio [OR] 1.93, 95%CI 1.26-2.97), tobacco (OR 4.09, 95%CI 2.43-6.90), duration of symptoms (OR 1.02, 95%CI 1.01-1.04), MPD size (OR 1.22, 95%CI 1.11-1.33), and MPD stricture (OR 8.50, 95%CI 5.01-14.42) were independent predictors of persistent pain. CONCLUSIONS: Alcohol, tobacco, duration of symptoms, MPD size and stricture were independent predictors of persistent pain after successful ESWL. A multidisciplinary team approach that includes behavioral therapy and surgical options should be considered for such patients.

Impact of ductal interventions on diabetes in patients with chronic pancreatitis.

BACKGROUND AND AIM: Even though ductal interventions in chronic pancreatitis (CP) are known to improve pain, its impact on diabetes is unclear. In this cohort study, we evaluated the impact of ductal interventions on diabetes in these patients. METHODS: Consecutive patients with CP visiting the pancreas clinic between August 1, 2011, and July 21, 2012, were enrolled and followed until December 2018. Detailed clinical, laboratory, imaging, and treatment data were recorded at enrolment and follow-up. Patients were followed up every 6 months through hospital visit and/or telephonic interview. Risk factors for diabetes were evaluated using logistic regression. The impact of ductal interventions on diabetes was evaluated using Kaplan-Meier survival analyses and Cox proportional hazards. RESULTS: A total of 644 patients were enrolled of which 137 were excluded. Of these, 326 (64.3%) patients had idiopathic CP, and 283 (55.8%) patients underwent ductal intervention. The cumulative incidence of diabetes was 57.9%. Median duration between symptom onset and ductal intervention was similar irrespective of diabetes (2.6 [0.6-6.0] vs 3.0 [1.0-5.5] years; P = 0.69). Alcohol intake and pancreatic ductal calculi were independent risk factors for diabetes (odds ratio [95% confidence interval] of 2.05 (1.18-3.55), P = 0.01, and 2.05 (1.28-3.28), P = 0.003, respectively). Kaplan-Meier analyses revealed that diabetes free interval was significantly longer in patients undergoing ductal interventions, predominantly in those with idiopathic CP with obstructive ductal calculi (hazard ratio [95% confidence interval] 0.39 [0.28-0.55]; P < 0.0001). There were no differences in glycemic status in patients with non-idiopathic CP and those with pre-existing diabetes. CONCLUSION: Early ductal intervention could delay development of diabetes in patients with idiopathic CP with obstructive ductal calculi.