الفهرس 
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Abstract
Complications are an integral component of the outcome of an intervention such as ERCP. Pancreatitis remains the most common and most feared complication after ERCP. The recognition of the risk factors for PEP and high risk patients is highly desirable so as to avoid the procedure at all in case of diagnostic ERCP, also to avoid high risk techniques during ERCP and for close follow up for these patients after the procedure and for early therapeutic approach during or after the procedure.
The primary aim of this study was to evaluate the commonest postulated risk factors for post-ERCP pancreatitis in patients with obstructive jaundice. Identification and evaluation of overall ERCP related complications was prospectively evaluated as a secondary goal of this study.
This prospective study was performed on 581 consecutive adult patients with obstructive jaundice referred to gastro-intestinal endoscopy unit of Assuit University hospital (540 patients) and gastro-intestinal endoscopy unit of surgery department of Sohag University hospital (141 patients) between June 2010 and June 2012. They were 225 male (38.7%) and 356 female (61.3%), their ages ranged between 18 and 73 years with a mean of 44.8 ± 13.9.
All patients were subjected pre-endoscopically to initial evaluation in the form of history taking, clinical examination and laboratory and imaging investigations. During ERCP, time of the whole procedure, time of manipulation of papilla, number of attempts of cannulation, number of pancreatic duct cannulation and injection, degree of difficulty of stone extraction, sphincterotomy, precut, balloon sphincteroplasty and trainee participation were recorded. After ERCP patients were monitored for at least six hours to detect symptoms and signs of pancreatitis, together with measurement of serum amylase four hours after the procedure.
The Cannulation of the papilla of vater was successful in 96.7% (562 patients) and failed in 3.3% (19 patients). Causes of failure were as follows: small and stenosed papilla was found in 10 patients (1.7%), duodenal diverticulum in 5 patients (0.9%), and ampullary tumor in 4 patients (0.7%).
The overall morbidity rate was 12.7% (74 cases), and the mortality rate was 0.51% (3 cases). The first died from sever pancreatitis, the second from pulmonary embolism, and the third from sever bradyarrthymia.
Estimation of serum amylase level after ERCP showed that 25% of cases had no hyperamylasemia, 66.1% of cases had asymptomatic hyperamylasemia and 8.9% of cases had acute pancreatitis.
Pancreatitis was the most common complication, and it was mild in 63.5%, moderate in 28.8% and sever in 7.7% of cases. Pancreatitis-related median hospital stay was 2.9, 6.5 and 17.5 days for mild, moderate and severe disease. The PEP related mortality rate was 1.9% (1 case) due to sever acute pancreatitis, No deaths were reported for mild or moderate pancreatitis.
Bleeding occurred in 11 patients (1.89%), Cholangitis developed in 4 cases (0.69 %), perforation occurred in 2 cases (0.34%), bradyarrthymia occurred in 2 cases (0.34%), cholecystitis in 1 case (0.17%), pulmonary embolism in 1 case (0.17%) and basket trapping occurred in 1 case (0.17%).
Technique-related risk factors are probably more numerous and potent than patient-related ones in the risk of post-ERCP pancreatitis. 7 risk factors were identified to be independently associated with pancreatitis, 2 were patient-related risk factors (i.e., history of previous pancreatitis and history of previous PEP), and 5 were procedure-related risk factors (i.e., precut sphincterotomy, difficult cannulation, pancreatic duct cannulation, ≥ 2 pancreatic duct injection, and difficult stone extraction).
History of previous PEP and history of previous pancreatitis were associated with 8-fold risk for recurrent attack of PEP.
Age was not a significant independent risk factor for PEP although PEP had inverse relationship with age (the younger the patient the higher the percentage of pancreatitis – 10% vs. 5%). Also, sex of patients was not a significant independent risk factor for PEP although females were found to have higher rates of PEP compared to males (11.5 % vs. 4.9%).
Previous cholecystectomy, previous sphincterotomy, preoperative total serum bilirubin, cause of obstructive jaundice and CBD diameter were not a significant risk factors for PEP.
Increasing number of attempts at cannulating Vater’s papilla was the most risky independent factor for post-ERCP pancreatitis. More than 15 attempts raised the risk 10-fold while 6 to 15 attempts raised the risk threefold, independently of the other patient- and procedure-related risk factors.
Pancreatic duct cannulation (≥ 1 time) and pancreatic duct injection (≥ 2 times) were significant independent factors for PEP with a tripled risk.
The degree of difficulty of stone extraction was found to be a significant independent risk (two-fold) for PEP in patients with gall stone disease. PEP had inverse relationship with the degree of difficulty of stone extraction (the difficulty the stone extraction the higher the percentage of pancreatitis).
Precut was considered a barely risk factor for PEP. Moreover, this study found that early pre-cut was safer than either delayed pre-cut or multiple attempts at cannulating the papilla (13.6% versus 25.6% and 28.6%), supporting the concept that in expert hands pre-cut might be preferable to repeated cannulation attempts, especially in patients at high risk for post-procedure pancreatitis.
The total time of the procedure was not a significant independent risk factor for PEP (the mean time was 27.7 minutes vs. 32.4 minutes). Also, the mean time of cannulation of the papilla did not differ significantly between the pancreatitis and non pancreatitis group (6.6 minutes vs. 8.4 minutes).
Standard biliary sphincterotomy, balloon sphincteroplasty and Trainee participation were not associated with any increase in the incidence of PEP.
Conclusions and Recommendations
• Rise in serum amylase level of three times the upper normal limit or more was universally associated with clinically relevant acute pancreatitis.
• A rise in serum amylase level less than 3 times the upper normal limit is a common occurrence after ERCP, and is not clinically relevant and should not be considered a complication of ERCP.
• All patients should be followed by 4-hours serum amylase after the ERCP in order to early identification of patients with PEP for early and adequate management.
• Pancreatitis remains the most common complication of ERCP, but usually of mild form.
• Technique-related risk factors are probably more numerous and potent than patient-related ones in the risk of post-ERCP pancreatitis.
• 7 risk factors were identified to be independently associated with pancreatitis, 2 were patient-related risk factors (i.e., history of previous pancreatitis and history of previous PEP), and 5 were procedure-related risk factors (i.e., precut sphincterotomy, difficult cannulation, pancreatic duct cannulation, ≥ 2 pancreatic duct injection, and difficult stone extraction).
• Excessive manipulation of the papilla during the procedure should be avoided by the earlier use of precut sphincterotomy in expert hands.
• The importance of the avoidance of high-risk procedures such as unintentional pancreatic deep wire pass, pancreatic duct injection ≥ 2 times, prolonged cannulation time, prolonged procedure time and needle-knife precut, especially in high-risk patients.
• The use of non invasive techniques such as magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) should be considered for patients with unclear pancreaticobiliary pathology.
• In future studies, other host factors at the cellular level, including genetic susceptibility to pancreatitis, hormonal or inflammatory mediators should be examined, which will help further understand the mechanism of inflammatory response after ERCP.