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Introduction
Pancreatitis has been classified as acute pancreatitis (AP), acute recurrent pancreatitis (ARP), and chronic pancreatitis (CP). ARP is defined as at least two distinct episodes of AP with complete resolution of pain or complete normalization of serum pancreatic enzyme levels before a new episode of AP is diagnosed, regardless of the specific time interval between episodes of AP. CP is defined as abdominal pain typical of pancreatitis plus characteristic imaging findings, exocrine insufficiency plus imaging findings, or endocrine insufficiency plus imaging findings1-3. The causes may be obstructive or non-obstructive. The former include common bile duct cysts, pancreas divisum, annular pancreas, duodenal diverticulum, duodenal duplication, parasitic infection, and anomalies of the pancreaticobiliary junction. Non-obstructive causes include hereditary factors, autoimmune factors, cystic fibrosis, hyperlipidemia, trauma, medications, and hypercalcemia4-6. Endoscopic treatment aims to improve abdominal pain and prevent damage of the pancreatic parenchyma and duct, which can lead to exocrine and endocrine pancreatic complications7.
In recent years, endoscopic therapy has become a widely used primary treatment option for patients with abdominal pain due to a variety of pancreatic disorders, including ARP, CP, pancreatic duct leakage or disruption (pancreas divisum), pseudocyst drainage, and prevention of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP)7,8. One of the most common forms of pancreatic endotherapy is sphincterotomy and pancreatic stent placement. These are placed in the main pancreatic duct to relieve ductal obstruction, often in refractory abdominal pain due to strictures, stones, or papillary stricture. They have also been used in the minor papilla to treat symptomatic pancreas divisum secondary to a stenotic minor papilla8.
The purpose of this study was to evaluate the efficacy of using a pancreatic prosthesis to reduce pain in pediatric patients with ARP and CP.
Methods
We conducted a retrospective case series study from July 2013 to December 2021. The study was descriptive and observational. We included consecutive cases of children aged 6-16 years diagnosed with ARP and CP confirmed by clinical presentation and imaging studies, who persisted with abdominal pain despite medical treatment and whose clinical records had complete information. Medical treatment included a diet without cholecystokinetics, analgesics, and proton pump inhibitors.
Of the 14 patients who met the inclusion criteria, five were excluded due to incomplete records, loss of follow-up, or failure to achieve 24 months of follow-up from baseline.
We evaluated variables such as age, sex, number of episodes of pancreatitis before the endoscopic intervention, indication for pancreatic prosthesis placement, prosthesis replacement time, number of replacements, pancreatic duct diameter at baseline and at removal, complications, and clinical evolution after prosthesis removal. As part of the medical management, patients were prescribed a diet without cholecystokinetics and analgesic treatment for pain.
Before prosthesis placement, magnetic resonance cholangiopancreatography was performed to evaluate the presence of anatomical abnormalities, stenosis, stones, and pancreatic duct caliber. Subsequently, ERCP was performed to cannulate the pancreatic duct with a triple lumen sphincterotome; after the passage of the hydrophilic guide, a 3 mm sphincterotomy was performed, and a pancreatic prosthesis of 5 or 7 French of diameter by 5 or 7 cm length was placed, depending on the characteristics of the duct.
After placing this prosthesis, patients were followed up after 1 month to observe the clinical evolution, then every 6 months for prosthesis replacement, and after 24 months to evaluate the diameter of the pancreatic duct. Two prostheses were placed according to the diameter of the duct for better drainage.
The procedure was performed by a team of experienced pediatric endoscopists using adult duodenoscopes (TJF TYPE 160VF Olympus Tokyo Japan and ED530XT Fujifilm Corporation Japan), a triple lumen sphincterotome (Wilson-Cook Medical Inc., Winston-Salem, N.C.), hydrophilic guidewire (Wilson-Cook Medical Inc., Winston-Salem, N.C.), and pancreatic prosthesis (Wilson-Cook Medical Inc., Winston-Salem, N.C.).
All procedures were performed under general anesthesia by an experienced pediatric anesthesiologist. Procedures were performed in the radiology department, limiting fluoroscopy time with minimal radiation exposure and covering the patients´ genital organs. Ultravist 300 (Bayer AG Germany) 50% contrast was used to visualize the diameter of the affected duct; pancreatic duct measurements were obtained at the beginning and end of the study.
Ethical aspects
Following the Declaration of Helsinki, the study was approved by the hospital´s Health Research and Ethics Committee under number HIM-SR-2021-022.
Statistical analysis
A descriptive analysis was performed. The Shapiro´Wilk test was performed for quantitative variables, a non-parametric distribution was shown, and values were described as medians, minimums, and maximums. Frequencies and percentages were used for qualitative variables. STATA version 11 was used.
Results
Nine patients were included in the study: five females (56%) and four males (44%). The median age was 12.4 years, ranging from 9 to 16 years. Cholangiopancreatography showed pancreatic duct dilatation of 3 mm in two, 4 mm in three, and 5 mm in four patients. In six cases (67%), no etiology was found, so they were considered idiopathic after the studies. In three cases (33%), an anatomical alteration (pancreas divisum) was found (Table 1). The main symptom in all cases was pain associated with elevated serum levels of pancreatic enzymes. Before study entry, patients had a median of 4.5 pancreatitis events (minimum 3 and maximum 7). The median follow-up period was 28 months (minimum 24 and maximum 40 months). Some patients had prolonged follow-up due to conditions that delayed prosthesis replacement: two patients were delayed because scheduled surgical procedures were suspended during the COVID-19 pandemic, and one adolescent became pregnant during follow-up and underwent postpartum replacement.
Table 1 Description of the nine patients after pancreatic prosthesis placement
| Case | Age/sex | ERCP/prosthesis used | Months of treatment | Complications | Post-removal follow-up (months) | Type of pancreatitis | Clinical manifestations | Previous pancreatitis | PD start body/tail | PD final body/tail | Therapeutic success |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Female 11 years | 5/5 | 26 | Pancreatitis post-ERCP and pain | 5 | ARP pancreas divisum | Pain Surgery Age-related discharge | 4 | 3 mm/2 mm | 8 mm/4 mm | No |
| 2 | Female 11 years | 6/8 | 40 | Pancreatitis post-ERCP Intraductal migration | 36 | CP idiopathic | Asymptomatic | 7 | 4 mm/2 mm | 8 mm/3 mm | Yes |
| 3 | Male 16 years | 4/4 | 24 | Pancreatitis post-ERCP | 6 | CP idiopathic | Asymptomatic Age-related discharge | 5 | 5 mm/3 mm | 6 mm/4 mm | Yes |
| 4 | Female 16 years | 4/4 | 31 | Pancreatitis post-ERCP | 6 | CP idiopathic | Asymptomatic Age-related discharge | 4 | 5 mm/3 mm | 8 mm/5 mm | Yes |
| 5 | Male 13 years | 5/6 | 34 | No | 4 | CP idiopathic | Asymptomatic | 5 | 5 mm/3 mm | 8 mm/3 mm | Yes |
| 6 | Male 11 years | 4/4 | 27 | Pancreatitis post-ERCP | 26 | ARP pancreas divisum | Asymptomatic | 3 | 4 mm/2 mm | 5 mm/2 mm | Yes |
| 7 | Male 16 years | 5/6 | 24 | No | 2 | ARP idiopathic | Asymptomatic Age-related discharge | 4 | 4 mm/2 mm | 6 mm/3 mm | Yes |
| 8 | Female 9 years | 5/6 | 24 | No | 12 | ARP idiopathic | Asymptomatic | 6 | 3 mm/2 mm | 8 mm/3 mm | Yes |
| 9 | Female 9 years | 5/7 | 26 | Pancreatitis post-ERCP | 27 | CP pancreas divisum | Asymptomatic | 3 | 5 mm/3 mm | 7 mm/4 mm | Yes |
ARP: acute recurrent pancreatitis; CP: chronic pancreatitis; ERCP: endoscopic retrograde cholangiopancreatography; PD: pancreatic duct.
A total of 43 procedures were performed, with a median of five per patient (range 4-6), including placement, replacement, and removal of the prosthesis. The replacement frequency was every 6.2 months (range 1-8 months); there was only one case where replacement had to be performed after 1 month due to obstruction of the prosthesis with pancreatitis, requiring the placement of a double prosthesis. The replacements performed between 7 and 8 months were due to the inactivity of the institution on the scheduled date due to the COVID-19 pandemic.
After 2 years of treatment or more than three exchanges, all nine patients had their prostheses removed. Eight patients (88.8%) remained asymptomatic 6 months after prosthesis removal. Three of them (33%) reached 18 years of age and were referred asymptomatic to an adult hospital for further follow-up. The remaining five patients (56%) are still under clinical follow-up; four have been asymptomatic for 12, 26, 27, and 32 months. The last patient required surgical treatment for pain relief 5 months after removal and was referred to an adult hospital for follow-up at age 18, remaining asymptomatic to date.
When the prostheses were removed, the diameter of the ducts increased (5 mm in one, 6 mm in two, 7 mm in one, and 8 mm in five). During the first year of the study, two patients had mild pancreatitis, one had two episodes, and the rest had no pain.
Complications reported after ERCP, sphincterotomy, prosthesis placement, prosthesis replacement, or removal were mild AP in seven patients (15.7%) after 43 procedures; one patient had migration of the intraductal prosthesis (2%), which was successfully removed and repositioned with an endoscopic balloon.
Discussion
Pain caused by pancreatitis (mainly ARP and PC) is a prominent and often debilitating symptom that usually does not disappear in the natural course of the disease; its mechanism may be because intraductal hypertension due to its obstruction. Initially, these conditions had to be treated by a specialist, but if the patient did not respond, or got complicated, surgery was necessary. Currently, with the advent of therapeutic ERCP, we have an intermediate treatment9,10.
Endoscopic therapy has become a widely used primary treatment option for patients with abdominal pain secondary to pancreatic changes in adults11-13. However, its detractors mention that the prosthesis produces a reaction with increased duct volume and fibrosis, especially when applied to a duct of normal caliber14,15. Some studies suggest that abdominal pain does not usually go away with this treatment15; in contrast, several reports in children suggest that this therapeutic approach can be performed safely and provide short-term relief of symptoms16-18.
In a 12-year study, Güitrón-Cantu et al.19 included 20 pediatric patients with ARP treated with sphincterotomy (70%), placement of a 7 French caliber pancreatic prosthesis (90%), and replacement with a 10 French prosthesis (50%) every 4-6 weeks, for a total of 35 procedures (average 1.7 sessions) at 24 months follow-up. A non-serious complication rate of 5.7% was reported, with a reduction in the severity and frequency of pain after the procedure; only one patient required bypass surgery. In contrast, we had less cases in a longer period, and we performed sphincterotomy, placement, and replacement with smaller caliber prostheses (5-7 French each), for a longer time and number of replacement sessions. Regarding complications, although we reported a higher percentage (15.7%) without mortality, pain relief and lack of response to treatment were similar.
Lans et al.20 reported prosthesis replacement every 3 or 4 months, with retention for 1 year and clinical improvement in 90%. Thus, a good clinical response was observed in these three studies (89-94%) despite having different prostheses caliber, distinct replacement times, and duration of treatment. This response was related to adequate drainage of the pancreatic duct. In addition, a low rate of non-serious complications was observed here (5.7% vs. 15%), consistent with Johanson et al.,21 who reported intraductal migration of the prosthesis as a complication in 5.2% vs. 1.7% in our study. Finally, Kohoutova et al.18 performed therapeutic ERCP with prosthesis placement in children with CP with a complication rate of 3%.
Regarding the persistence of symptoms after endoscopic treatment, Güitrón-Cantu et al.19 reported 5% (compared to 11.1% in our series) that ended up in derivative surgery with subsequent improvement, showing that both endoscopic and surgical procedures allow for clinical improvement5.
Therefore, we consider that pancreatic prosthesis placement by ERCP is a reproducible technique. It has the advantage of being an advanced and minimally invasive endoscopic procedure with a low percentage of complications, promoting a reduction in hospital stay and faster recovery. This technique contributes palliatively to the improvement of abdominal pain in appropriately selected children and as a bridge to surgery in those who do not improve. Due to the small sample size of our study, however, the results presented should be taken with caution.
In pediatric patients with ARP and CP and refractory abdominal pain, pancreatic prosthesis placement is effective and safe in relieving symptoms in the medium term (24 months) with minimal complications.
