Endoscopic vs. Surgical Interventions for Painful Chronic Pancreatitis: What is Needed for Future Clinical Trials

Abstract

The treatment of painful chronic pancreatitis remains controversial. The available evidence from two randomized controlled trials favor surgical intervention, whereas an endotherapy-first approach is widely practiced. Chronic pancreatitis is complex disease with different genetic and environmental factors, different pain mechanisms and different treatment modalities including medical, endoscopic, and surgical. The widely practiced step-up approach remains unproven. In designing future clinical trials there are some important pre-requisites including a more comprehensive pain assessment tool, the optimization of conservative medical treatment and interventional techniques. Consideration should be given to the need of a control arm and the optimal timing of intervention. Pending better designed studies, the practical way forward is to identify subgroups of patients who clearly warrant endotherapy or surgery first, and to design the future clinical trials for the remainder.

Controversies on the endoscopic and surgical management of pain in patients with chronic pancreatitis: pros and cons!

“…It is worth noting that the effect size of sham treatment in these studies is of a similar magnitude to that seen in studies investigating endoscopic and surgical treatment for painful CP (table 1). Unfortunately, the ethical challenges of conducting sham-controlled studies in surgery (open or laparoscopic) in CP are well recognised,59 but in contrast, it is possible to conduct sham-controlled endoscopic treatments 3…”

“…While there are many clinical studies that support invasive treatments, there is a paucity of high-quality randomised controlled trials (RCTs). As a result, the current guidelines for endoscopic and surgical treatments for painful CP are inconsistent and tend to reflect a specialty bias 3. For example, the German guidelines4 recommend surgery as the most effective treatment of pain, whereas the European Society of Gastrointestinal Endoscopy5 and the international evidence-based (HaPanEU) guidelines1 advice a ‘step-up approach’ incorporating both conservative, endoscopic and surgical treatment.…”

Assessing the value of endoscopic ultrasound in predicting symptom severity and long-term clinical course in chronic pancreatitis

“…Multiple studies have demonstrated that surgery (specifically pancreatic drainage and/or resection) represents a safe, effective, and durable intervention in patients with chronic pancreatitis that provides better long-term symptom relief than endoscopic interventions. 12,13,[17][18][19] This is reflected by our data, which demonstrates a nearly 50% long-term symptom relief rate even among patients who have failed endoscopic management. However, despite its safety, the risks of a surgical procedure exceed that of endoscopic interventions.…”

“…ERCP with stenting of the pancreatic duct increases drainage of the gland, which, for early stage disease, effectively decreases abdominal pain. [12][13][14][15] For more advanced disease, robust data for the immediate and long-term role of endoscopic stenting is lacking. 12,16 The subset of patients in whom endoscopic interventions provide adequate pain relief over the course of their disease remains unclear, though our findings suggest it may be limited to those patients meeting fewer EUS criteria for chronic pancreatitis.…”

“…20 Indeed, one of the major problems with a "step up" approachnamely, narcotic analgesics followed by endoscopic therapy followed by surgery as salvage therapyis a failure to address the chronic inflammatory process with either narcotics or endoscopy. 12 Patients additionally develop opioid dependence, which often persists despite addressing the underlying cause of their pain with a surgical procedure. Furthermore, they would have a lesser volume of functional exocrine and endocrine pancreatic tissue at the time of surgery and thus are at greater risk for post-operative pancreatic exocrine and/or endocrine insufficiency.…”