Pain In Chronic Pancreatitis Research Articles

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

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

Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial {1}

BackgroundCeliac plexus block has been commonly utilized for the treatment of chronic pancreatitis-associated abdominal pain. Prospective studies suggest efficacy in 30 to 50% of patients, although no randomized sham-controlled trials have been performed. The objective of this study is to assess the effect of endoscopic ultrasound (EUS)-guided celiac plexus block on abdominal pain in patients with documented chronic pancreatitis. MethodsThis is a two-arm randomized sham-controlled trial with blinded evaluators. The study will be conducted at multiple academic sites in the United States who are members of the United States Pancreatic Disease Study Group (USPG). Patients referred for EUS to exclude chronic pancreatitis as a cause of abdominal pain as well as those with established painful chronic pancreatitis undergoing EUS for another indication will be eligible. At the time of EUS with confirmation of chronic pancreatitis by standard EUS diagnostic criteria, patients will be randomized to either celiac plexus block or sham whereby an anesthetic and steroid combination will be injected into the celiac plexus or saline will be injected into the gastric lumen with the same type of needle as used for celiac plexus block, respectively. The main outcome measure will be a 50% reduction in abdominal pain using the Brief Pain Inventory Short Form (BPI-SF) at 1 month post-intervention. A number of secondary outcomes will be measured including visual analog scale (VAS), Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) pain scores, and quality of life using a pancreas-specific validated measure (PANQOLI).DiscussionIn this study, the effect of celiac plexus block on abdominal pain in patients with chronic pancreatitis will be compared to a sham intervention. This randomized trial will offer a definitive assessment of the role of celiac plexus block for the treatment of abdominal pain in this setting.Trial registration {2}ClinicalTrials.gov NCT 06178315. Registered on December 21, 2023

Pain in chronic pancreatitis: What can we do today?

The aim of this study is to illustrate the complexity of pain management in chronic pancreatitis (CP). In this context, pain represents the most common and debilitating symptom, and it deeply affects patient's quality of life. Multiple rating scales (unidimensional, bidimensional and multidimensional) have been proposed to quantify CP pain. However, it represents the result of complex mechanisms, involving genetic, neuropathic and neurogenic factors. Considering all these aspects, the treatment should be discussed in a multidisciplinary setting and it should be approached in a stepwise manner. First, a lifestyle change is recommended and nonsteroidal anti-inflammatory drugs represent the gold standard among medical treatments for CP patients. The second step, after medical approach, is endoscopic therapy, especially for complicated CP. In case of failure, tailored surgery represents the third step and decompressive or resection procedures can be chosen. In conclusion, CP pain's management is challenging considering all these complex aspects and the lack of international protocols.

Risk factors and a prediction model for pain recurrence after pancreatic stent removal in painful chronic pancreatitis.

Endoscopic pancreatic stenting (EPS) is an effective treatment modality for painful chronic pancreatitis. However, little is known about the factors that cause pain recurrence after stent removal, and there are no clear criteria for stent removal. We aimed to develop a prediction model for pain recurrence by identifying its risk factors. We retrospectively reviewed 95 patients who underwent EPS due to pain for the first time using a single plastic stent between January 2007 and July 2022 at our institute. Univariate and multivariate stepwise Cox proportional hazards models were used to identify the risk factors for pain recurrence, and a prediction model was developed based on the identified factors. Of the 95 enrolled patients, 89 (93.7%) achieved pain relief and 73 (76.8%) did stent removal. Of the 69 patients with a follow-up period ≥6 months after stent removal, 29 (42.0%) had pain recurrence during the median follow-up period of 59 months. Serum lipase level (p = 0.034) and pancreatic parenchymal thickness (p = 0.022) on computed tomography or magnetic resonance imaging were identified as independent risk factors for pain recurrence. The prediction model based on the identified factors had good discrimination ability, with a concordance index of 0.74, and could stratify pain recurrence rates. We identified the risk factors and developed a new prediction model for pain recurrence following stent removal. This model might be useful for decision-making in pancreatic stent management, such as deciding whether to remove a pancreatic stent, continue EPS, or convert to surgery.

Intravenous Lidocaine for Refractory Pain in Patients With Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis: A Multicenter Prospective Nonrandomized Pilot Study.

Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. Multicenter prospective nonrandomized pilot study included patients with moderate or severe pain (Numeric Rating Scale ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5 mg/kg was followed by continuous infusion at 1.5 mg/kg/hr. The dose was raised every 15 minutes until treatment response (up to a maximum 2 mg/kg/hr) and consecutively administered for 2 hours. Primary outcome was the mean difference in pain severity, preinfusion, and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥1.3 points was considered clinically relevant. Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day 1 was 1.1 (SD ± 1.3) points for patients with PDAC and 0.5 (SD ± 1.7) for patients with CP. A clinically relevant decrease in BPI on day 1 was reported in 9 of 29 patients (31%), and this response lasted up to 1 month. No serious complications were reported, and only 3 minor complications (vertigo, nausea, and tingling of mouth). Treatment with lidocaine did not impact quality of life. Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.

Long-term clinical outcomes of extracorporeal shockwave lithotripsy and endoscopic retrograde cholangiopancreatography for pancreatic duct stone treatment in patients with chronic pancreatitis.

Extracorporeal shock wave lithotripsy for pancreatic stones (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) are the preferred therapeutic approaches for painful chronic pancreatitis (CP) with pancreatic stones. This study aimed to report the short- and long-term outcomes following P-ESWL and ERCP in a large cohort with CP. Patients with painful CP and pancreatic stones >5 mm in size, who underwent P-ESWL and subsequent ERCP between March 2011 and June 2018, were included in this retrospective-prospective mixed observational study. The total stone clearance rates were recorded. All patients were followed up until the end of March 2024, with the visual analogue scale (VAS) for pain, pain type, quality-of-life scores and other relevant information recorded. A total of 2071 patients underwent P-ESWL, and 93.1% of them subsequently underwent ERCP during the study period. Patients were followed up for an average of 11.8 years from the onset of CP and 6.7 years from the first P-ESWL procedure. Complete stone clearance was achieved in 73.7% of the patients. At the end of the follow-up period, 70.1% of the patients achieved complete pain remission. Significant pain type conversion and lower VAS scores were observed in the patients after treatment. Quality-of-life scores and body mass indices increased after P-ESWL and ERCP. P-ESWL and ERCP are effective and minimally invasive treatments for pancreatic stones in patients with painful CP. Most patients achieved complete pain relief, and pain-type conversion was common after treatment. (ClinicalTrials.gov: NCT05916547).

Combined Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Pancreatography for Painful Chronic Pancreatitis: Is It Effective?

AbstractManagement of pain in chronic pancreatitis (CP) is challenging, and surgery used to be the intervention of choice in patients having pain refractory to medical therapy. Advancement in minimally invasive interventions resulted in a paradigm shift in the management of pain in CP. Pancreatic endotherapy is currently considered the intervention of choice for the management of ductal hypertension in CP. However, multiple mechanisms including ductal hypertension and neurogenic as well as psychological factors contribute to the causation of pain in CP and therefore no single intervention is effective in all patients. The precise role of interventional procedure in a complex disease like CP with multiple pathogenic mechanisms requires a prospective comparative study with a sham group and there are no such comparative studies in the literature. In this news and views, we discuss a recently published sham-controlled randomized trial (Combined extracorporeal shock wave lithotripsy and endoscopic treatment for pain in chronic pancreatitis (SCHOKE) trial) that examined the efficacy of extracorporeal shock wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with the sham procedure.

Ductal Intervention in Chronic Pancreatitis: Impact on Glycemic Control and Endocrine Insufficiency Management.

Background and aim Pancreatic endotherapy has been established as a viable and effective modality for the management of pain in chronic pancreatitis (CP). However, its impact on endocrine insufficiency has been rarely reported. In this retrospective study, we aimed to assess the impact of endotherapy on glycemic status and the management of diabetes in these patients. Methods A retrospective review of a prospectively maintained database of patients with CP with pain presenting to the King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, India, from December 2021 to May 2023 was done. Detailed clinical, laboratory, imaging, and treatment data were recorded. Endocrine dysfunction was defined as glycosylated hemoglobin (Hba1C) ≥6.5 g/dl. The status of endocrine function (Hba1C values) before and after endotherapy, as well as the requirement of oral hypoglycemic agent (OHA) and/or insulin, was recorded. Results One hundred forty-one patients underwent endoscopic retrograde cholangiopancreatography for the management of pain (mean age: 35 years, 74.5% males). Prior to endotherapy, pathological endocrine dysfunction was seen in 60 patients (42.5%). The mean HbA1c value was 8.46 g/dl (4.5-16.1g/dl). OHAs alone were used in 13/60 (21.6%), and 34/60 (56.6%) required insulin. A combination of OHA and insulin was required in 13/60 (21.6%) of patients. Post-endotherapy, none of the patients were on a combination of OHAs and insulin; 5/13 (38.4%) patients were on OHAs alone, while 8/13 (61.5%) patients were shifted to insulin. Out of the total 47 patients who required insulin, insulin could be stopped in 15/47 (31.9%) of patients. Patients who demonstrated improvement in endocrine dysfunction had significantly lower HbA1c values (6.38 vs. 8.07 g/dl, p < 0.001), a higher proportion of patients with idiopathic pancreatitis (73.3% vs. 22.2%, p = 0.004), and a lower proportion of patients with concomitant exocrine insufficiency (13.3% vs. 53.3%, p = 0.007). Conclusions One-third of the patients had improvements in endocrine dysfunction. Early ductal intervention in a selected subset of patients with CP may have the potential to improve glycemic status.

Treating Chronic Pancreatitis Pain using Extracorporeal Shock-Wave Lithotripsy and Endoscopy

Treating Chronic Pancreatitis Pain using Extracorporeal Shock-Wave Lithotripsy and Endoscopy

A sham-controlled, randomized trial of spinal cord stimulation for the treatment of pain in chronic pancreatitis.

Spinal cord stimulation (SCS) has emerged as a treatment option for patients with chronic pancreatitis (CP) who experience pain that does not respond to standard interventions. However, there is a lack of sham-controlled trials to support its efficacy. This randomized, double-blinded, sham-controlled, cross-over trial enrolled 16 CP patients with insufficient pain relief from standard therapies. Patients underwent high-frequency (1000 Hz) paraesthesia-free SCS or sham for two 10-day stimulation periods, separated by a 3-day washout period. The primary outcome was daily pain intensity registered in a pain diary based on a numeric rating scale (NRS). Secondary outcomes included various questionnaires. Quantitative sensory testing was used to probe the pain system before and after interventions. The average daily pain score on the NRS at baseline was 5.2 ± 1.9. After SCS, the pain score was 4.2 ± 2.1 compared to 4.3 ± 2.1 in the sham group (mean difference -0.1, 95% CI [-1.4 to 1.1]; P = 0.81). Similarly, no differences were observed between groups for the maximal daily pain score, secondary outcomes or quantitative sensory testing parameters. During an open-label, non-sham-controlled and non-blinded extension of the study, the average daily NRS was 5.2 ± 1.7 at baseline, 3.2 ± 1.8 at 3 months, 2.9 ± 1.9 at 6 months and 3.4 ± 2.2 at 12 months of follow-up (P = 0.001). In this first sham-controlled trial of SCS in painful CP, we did not find evidence of short-term pain relief with paraesthesia-free high-frequency (1000 Hz) stimulation. However, evaluation of the long-term effect by larger sham-controlled trials with long-term follow-up is warranted. In this first sham-controlled trial to apply high-frequency (1000 Hz) spinal cord stimulation in patients with visceral pain due to chronic pancreatitis, we did not find evidence for clinically relevant pain relief. Taken together with potential procedure-related complications, adverse effects and costs associated with spinal cord stimulation, our findings question its use for management of visceral pain.

Minimally invasive total pancreatectomy with islet autotransplantation for chronic pancreatitis: the robotic approach.

Total pancreatectomy with islet autotransplantation (TPIAT) treats refractory pain in chronic pancreatitis, prevents episodes of acute exacerbation, and mitigates postoperative brittle diabetes. The minimally invasive (MIS) approach offers a decreased surgical access trauma and enhanced recovery. Having established a laparoscopic TPIAT program, we adopted a robotic approach (R-TPIAT) and studied patient outcomes compared to open TPIAT. Between 2013 and 2021, 61 adult patients underwent TPIAT after a comprehensive evaluation (97% chronic pancreatitis). Pancreatic islets were isolated on-site during the procedure. We analyzed and compared intraoperative surgical and islet characteristics, postoperative morbidity and mortality, and 1-year glycemic outcomes. MIS-TPIAT was performed in 41 patients (67%, 15 robotic and 26 laparoscopic), and was associated with a shorter mean length of intensive care unit stay compared to open TPIAT (2.9 vs 4.5days, p = 0.002). R-TPIAT replaced laparoscopic TPIAT in 2017 as the MIS approach of choice and demonstrated decreased blood loss compared to open TPIAT (324 vs 843mL, p = 0.004), similar operative time (609 vs 562min), 30-day readmission rate (7% vs 15%), and 90-day complication rate (13% vs 20%). The glycemic outcomesincluding C-peptide detection at 1-year (73% vs 88%) and insulin dependence at 1-year (75% vs 92%) did not differ. The mean length of hospital stay after R-TPIAT was 8.6days, shorter than for laparoscopic (11.5days, p = 0.031) and open TPIAT (12.6days, p = 0.017). Both MIS approaches had a 1-year mortality rate of 0%. R-TPIAT was associated with a 33% reduction in length of hospital stay (4-day benefit) compared to open TPIAT. R-TPIAT was similar to open TPIAT on measures of feasibility, safety, pain control, and 1-year glycemic outcomes. Our data suggest that robotic technology, a new component in the multidisciplinary therapy of TPIAT, is poised to develop into the primary surgical approach for experienced pancreatic surgeons.

A case series of fluoroscopy-guided neurolytic splanchnic nerve block for chronic pancreatitis pain.

Splanchnic nerve block (SPN) with local anesthetic and steroid is used to relieve the pain of chronic pancreatitis. However, it does not provide long-lasting relief. We hypothesize that the use of 70% alcohol will give adequate analgesia for more than months. The primary objective was to find out the analgesic efficacy of the use of 70% alcohol with SPN. Secondary objectives included the incidence of side effects, analgesic consumption postintervention, quality of life (QOL) assessed via a self-reported quality of life scale, and repeat block during the 1-year follow-up period. Retrospective analysis of all patients with chronic pancreatitis who received bilateral SPN over the last 4 years. SPN was performed using the posterior retrocrural approach with the patient in the prone position as described in the literature using a 23 G × 90 mm spinal needle bilaterally at the level of T12 using C-arm/fluoroscopy guidance. Data were collected from the procedure book of the pain clinic and medical records. Quantitative data for change in pre- to post-block VAS score was collected using the non-parametric Wilcoxon signed ranks test. The baseline VAS, post-procedure VAS, and VAS at 3 months follow-up was 7.69 ± 1.3,2.44 ± 0.96 and 1.56 ± 1.15. A pairwise comparison of VAS performed between baseline and immediate post-procedure, baseline, and VAS at 3 months was found to be highly significant. Fluoroscopy-guided neurolytic SPN with 70% alcohol gives significant pain relief for more than 3 months. It also leads to improvement in 3 months QOL.

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

No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis. To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones. 24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781). Asian Institute of Gastroenterology in India from February 2021 to July 2022. 106 patients with chronic pancreatitis. Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures. 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. 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. Single-center study and limited duration of follow-up. In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief. Asian Institute of Gastroenterology and Aalborg University Hospital.

Pain management in chronic pancreatitis

Pain in chronic pancreatitis (CP) is difficult to manage. Many patients suffer from inadequate pain relief, completely incapacitating them in their daily activities. Historically, despite their well-known adverse effects, opioids have been the pillar of treatment regimens in painful CP. The management is now gradually evolving with a better understanding of the underlying pathophysiology of CP-related pain. Clinicians should follow a holistic approach to the management of CP-associated pain, which must involve lifestyle changes that are coupled with analgesic medications and other pain-relieving interventions. Furthermore, there is no easy cure for vanquishing CP-associated pain. Each patient must be evaluated on a case-by-case basis by a multidisciplinary team to decide which treatment option is best suited for that individual.

Autologous Pancreatic Islet Cell Transplantation Following Pancreatectomy for Pancreas Diseases Other Than Chronic Pancreatitis: A 15-y Study of the Milan Protocol.

Pancreatogenic diabetes, a consequence of pancreatic tissue loss following pancreatectomy, poses a significant challenge for patients undergoing pancreatic surgery. Islet autotransplantation (IAT) offers a promising approach to prevent or alleviate pancreatogenic diabetes, but its application has been limited to individuals with painful chronic pancreatitis. This study presents a 15-y clinical experience with the Milan Protocol, which expands IAT after pancreatectomy to a broader spectrum of patients with malignant and nonmalignant pancreatic diseases. The analysis evaluates feasibility, efficacy, and safety of IAT. Modified Igls criteria validated through the arginine test and mixed meal tolerance tests were used to assess long-term metabolic outcomes. Between November 2008 and June 2023, IAT procedures were performed on 114 of 147 candidates. IAT-related complications occurred in 19 of 114 patients (16.7%), with 5 being potentially serious. Patients exhibited sustained C-peptide secretion over the 10-y follow-up period, demonstrating a prevalence of optimal and good beta-cell function. Individuals who underwent partial pancreatectomy demonstrated superior metabolic outcomes, including sustained C-peptide secretion and a reduced risk of developing diabetes or insulin dependence compared with those who underwent total pancreatectomy. For patients who had total pancreatectomy, the quantity of infused islets and tissue volume were identified as critical factors influencing metabolic outcomes. An increased risk of recurrence or progression of baseline diseases was not observed in subjects with neoplasms. These findings provide valuable insights into the benefits and applications of IAT as a therapeutic option for pancreatogenic diabetes after pancreatic surgery, expanding its potential beyond painful chronic pancreatitis.

Targeted Drug Delivery for the Treatment of Abdominal Pain in Chronic Pancreatitis: A Retrospective Case Series.

The objective of this article is to perform a retrospective review of CP patients treated with TDD versus OOT to compare chronic pain control and consumed morphine-equivalent doses. Patients receiving TDD between September 2011 and August 2018 were included. All patients were weaned off oral opioids one week before intrathecal trial and pump implantation. Patients with intrathecal trials providing at least 50% pain relief underwent pump implantation. Data were collected while on OOT and at two weeks, three months, and nine months post-implant. Data were analyzed with Microsoft Excel 365 MSO using means and standard deviations. P-values were calculated using a two-tailed student's t-test with paired two-sample means. Twenty-three patients were analyzed. Pre-trial average pain score was 6.5/10 with a mean improvement with trials greater than 71%. The mean chronic baseline oral morphine milligram equivalents (MME) was 188. The mean MME on TDD at two weeks (0.36), three months (1.39), and nine months (2.47) were significantly lower than OOT. Mean pain scores were 6, 4.9, and 5.6 at two weeks, three months, and nine months, respectively, compared to 6.5 on OOT. The results of this study indicate that TDD provides improved pain control with significantly lower opioid doses.

Efficacy of Endoscopic Therapy in Symptomatic Pancreatic Divisum: A Systematic Review and Meta-analysis.

Pancreas divisum (PD) is a congenital malformation of the pancreas and is implicated as a cause of pancreatitis. The role of endotherapy has been variable in symptomatic PD indicated by recurrent acute pancreatitis (RAP), chronic pancreatitis (CP), or chronic pancreatic-type abdominal pain (PP). The aim of this study was to analyze the pooled data to determine the success of endoscopic intervention for pancreas divisum. We conducted a comprehensive search of several databases (inception to July 2023) to identify studies reporting on the use of endoscopic therapy in symptomatic pancreatic divisum. The random-effects model was used to calculate the pooled rates and I2% values were used to assess the heterogeneity. A total of 27 studies were retrieved that reported endoscopic intervention in pancreatic divisum. The calculated pooled rate of technical success was 92% (95% CI: 87-95; I2=63%). The calculated pooled rate of clinical success was 65% (95% CI: 60-70; I2=60%). The rate of clinical success by PD subtypes was highest in RAP at 71% (95% CI: 65-76; I2=24%). Available studies had significant heterogeneity in defining clinical success. The rate of adverse events was 71% (95% CI: 65-76; I2=24%). The role of endoscopic therapy in pancreatic divisum is variable with the highest success rate in recurrent acute pancreatitis. Endoscopic intervention is associated with a higher-than-usual rate of adverse events, including post-ERCP pancreatitis.

Safety, Tolerability, and Dose-Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis: Protocol for a Phase 1 Clinical Trial to Determine Safety and Identify Side Effects.

Chronic abdominal pain is the hallmark symptom of chronic pancreatitis (CP), with 50% to 80% of patients seeking medical attention for pain control. Although several management options are available, outcomes are often disappointing, and opioids remain a mainstay of therapy. Opioid-induced hyperalgesia is a phenomenon resulting in dose escalation, which may occur partly because of the effects of opioids on voltage-gated sodium channels associated with pain. Preclinical observations demonstrate that the combination of an opioid and the antiseizure drug lacosamide diminishes opioid-induced hyperalgesia and improves pain control. In this phase 1 trial, we aim to determine the safety, tolerability, and dose-limiting toxicity of adding lacosamide to opioids for the treatment of painful CP and assess the feasibility of performance of a pilot study of adding lacosamide to opioid therapy in patients with CP. As an exploratory aim, we will assess the efficacy of adding lacosamide to opioid therapy in patients with painful CP. Using the Bayesian optimal interval design, we will conduct a dose-escalation trial of adding lacosamide to opioid therapy in patients with painful CP enrolled in cohorts of size 3. The initial dose will be 50 mg taken orally twice a day, followed by incremental increases to a maximum dose of 400 mg/day, with lacosamide administered for 7 days at each dose level. Adverse events will be documented according to Common Terminology Criteria for Adverse Events (version 5.0). As of December 2023, we have currently enrolled 6 participants. The minimum number of participants to be enrolled is 12 with a maximum of 24. We expect to publish the results by March 2025. This trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of opioids in treating painful CP. It is anticipated that lacosamide will prove to be safe and well tolerated, supporting a subsequent phase 2 trial assessing the efficacy of lacosamide+opioid therapy in patients with painful CP, and that lacosamide combined with opiates will lower the opioid dose necessary for pain relief and improve the safety profile of opioid use in treating painful CP. Clinicaltrials.gov NCT05603702; https://clinicaltrials.gov/study/NCT05603702. PRR1-10.2196/50513.

Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial

IntroductionTreatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent...

Extended Partington procedure for chronic pancreatitis: One-year follow-up results

Abstract Background Over half of the patients who underwent the Partington procedure for painful chronic pancreatitis developed recurrent pain attacks. This occurs because the proximal ducts at the head of the pancreas, often containing stones, are left undrained. To overcome this pitfall, an extended Partington procedure is recommended. The aim of this study was to assess our 1-year follow-up results of the extended Partington procedure in patients with painful chronic pancreatitis. Materials and Methods This prospective study comprises patients undergoing extended Partington procedures who were followed for at least 1 year. Data were collected preoperatively and postoperatively in a fixed-interval fashion at 3 months, 6 months, and 1 year. Results Thirty-one patients underwent assessment. At 1-year follow-up, effective and complete pain relief was achieved in 81% and 55% of patients, respectively. The Izbicki pain score decreased significantly; the median dropped from 47.5 to 4.4. The quality of life using SF-12 physical and mental component summary improved significantly; the medians increased from 41.7 to 93.8, and 47.5 to 86.7, respectively. Endocrine function remained stable. Exocrine insufficiency developed in most patients as a natural progression of chronic pancreatitis. Two patients had complications directly related to surgical procedures (6%). No early postoperative deaths occurred. Conclusions Extended Partington procedure for chronic pancreatitis results in excellent pain relief and quality of life improvement, with a low morbidity rate, and does not worsen pancreatic function. It should replace the original Partington procedure in treating painful chronic pancreatitis.