Evaluate the benefits, risks and costs of early surgical intervention as an alternative to current step-up practice for CP.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is pain assessed with the Izbicki pain score.
Secondary outcome
Secondary outcomes are severe complications, mortality, cost-effectiveness,
quality of life, pancreatic insufficiency, alternative pain scales, hospital
admissions and number of performed interventions.
Background summary
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.
Study 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
Intervention
Patients will be randomly allocated to either A) early surgical intervention or
B) optimal current step-up practice and will receive the following
interventions:
Group A. 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 B. 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.
Study burden and risks
In group A (early surgery) the risks are that of surgery. There may be
complications such as infection, bleeding into the abdominal cavity or damage
to the intestine. Sometimes these complications may prolong the hospital stay
or sometimes a second operation is needed.
In group B (optimal current step-up practice) the medication can cause
constipation, itching, drowsiness and may cause addiction when used for a long
period of time. At endoscopy, there are risks of damage to the intestine,
pancreas or bile ducts. This can lead to a longer hospital stay or a second
operation.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18 years
2. Confirmed chronic pancreatitis: according to the following criteria (adapted from the M-ANNHEIM diagnostic criteria):
* typical clinical history of chronic pancreatitis (i.e. recurrent pancreatitis or abdominal pain), and:
* one or more of the following additional criteria for the diagnosis of chronic pancreatitis:
a. Pancreatic calcifications
b. Moderate or marked ductal lesions (according to the Cambridge classification) on magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT) or endoscopic ultrasounds (EUS) imaging
c. Marked and persistent exocrine insufficiency (defined as: a. pancreatic steatorrhea clearly relieved by enzyme supplementation, and/or b. fecal elastase levels of * 200 micro gram/gram)
3. Dilated pancreatic duct: dilated pancreatic duct of * 5 mm (established by MRCP, CT or EUS), with or without enlargement of the pancreatic head
4. Presence of moderate, non-debilitating pain. This will be defined as chronic or recurrent abdominal pain sufficiently relieved with non-opioid analgesics;Patients will be eligible for randomization to one of the trial arms when the randomization criteria are met:
* In patients with chronic abdominal pain related to chronic pancreatitis: a need to upgrade pain medication from non-opioids to opioid analgesics (opioids needed at least 3 days per week) and persistently needed for at least 2 weeks in a row
* In patients with recurrent flare ups of chronic pancreatitis (including episodes of acute on chronic pancreatitis) and pain-free intervals that:
- have occurred at least 3 times during one year (i.e. 12 months);
- during at least 7 consecutive days;
- necessitate opioid use during flare up;
- impairs the patient in daily activities.
* Informed consent for randomization
Exclusion criteria
* History of prolonged need of opioids: history for need for strong opioids for CP for a total period over 2 months or a history for need for weak opioids for CP for a total period of 6 months in the last 2 years
* Previous pancreatic surgery
* Previous endoscopic dilatation or stenting of the pancreatic duct. Patients with previous endoscopic intervention for biliary obstruction, without intervention involving the pancreatic duct, will be eligible for the trial.
* Episode of biliary obstruction in the last 2 months (defined as jaundice or bilirubine levels * 25 micromol / L) or the presence of a stent in the common bile duct (CBD).
* Proven autoimmune pancreatitis (including elevated levels of gamma-globulins (IgG))
* Stones and strictures exclusively located in the tail of the pancreas (defined as to the left of the left border of the vertebra) with relatively normal pancreatic head and corpus.
* Fully impacted stones casting the entire main pancreatic duct (from head to tail) and side branches.
* Suspected or established pancreatic malignancies
* Life expectancy of < 1 year for any reason
* Presence of duodenal obstruction necessitating surgery, as judged by the expert panel
* Presence of a pseudocyst larger than 6 cm necessitating intervention, as judged by the expert panel
* Contra-indications for surgery, always evaluated by the expert panel (e.g. American Society of Anesthesiology class IV, severe portal hypertension due to occluded portal vein)
* Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN45877994 |
| CCMO | NL34701.018.10 |