Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis.

Rationale:

In current clinical practice, surgical intervention for chronic pancreatitis (CP) is primarily kept as a last resort after medical and endoscopic management has failed and disease severity has become unbearable. Recent evidence suggests that earlier surgical intervention benefits patients in terms of better pain control and preservation of pancreatic function.



Objective:

Evaluate the benefits, risks and costs of early surgical intervention as an alternative to current step-up practice for CP.



Study design:

A multi-center strategy randomized controlled trial.



Study population:

Patients with confirmed CP and dilated pancreatic duct (≥ 5mm) with moderate pain (pain relieved without opioids) will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (need for opioid analgesics) the patient will be randomized to one of the intervention arms. An Expert Panel of CP specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible.



Intervention:

Patients will be randomly allocated to either:

1. Early surgical intervention;

2. Optimal current step-up practice.

They will receive the following interventions:

Group 1: Early surgical intervention:

Surgical drainage of the pancreatic duct (pancreaticojejunostomy) if pancreatic head is not enlarged (< 4 cm); or surgical drainage of the pancreatic duct and resection of the head of the pancreas (Frey procedure) if pancreatic head is enlarged (≥ 4cm);

Group 2: Optimal current step-up practice:

Step 1: Optimal medical management, if not effective followed by;

Step 2: Endoscopic intervention, and if not effective followed by;

Step 3: Surgical intervention.



Main study parameters/endpoints:

Primary outcome is pain assessed with the Izbicki pain score. Secondary outcomes are severe complications, mortality, cost-effectiveness, quality of life, pancreatic insufficiency, alternative pain scales, hospital admissions and number of performed interventions.

We hypothesis that early surgical intervention results in less pain over the study period and is more cost-effective than the optimal current step-up practice.

The patient follow-up will be completed 18 months after randomization for the primary endpoint, the secondary endpoints and the other research questions.

Intervention group:

Early surgical intervention: Surgical drainage of the pancreatic duct (pancreaticojejunostomy) if pancreatic head is not enlarged (< 4 cm); or surgical drainage of the pancreatic duct and resection of the head of the pancreas (Frey procedure) if pancreatic head is enlarged (4cm).



Control group:

Optimal current step-up practice:

Step 1: Optimal medical management, if not effective followed by;

Step 2: Endoscopic intervention, and if not effective followed by;

Step 3: Surgical intervention.