Endoscopic retrograde cholangiopancreatography (ERCP) is a useful technique for the diagnosis and treatment of biliary-pancreatic diseases. With the improvement of the technique and endoscopic accessories, the safety of ERCP has increased and it has been used widely in the clinic.1-4 In this study, we analyzed retrospectively 2075 patients who underwent diagnostic and therapeutic ERCP, to evaluate ERCP for the diagnosis and treatment of biliary-pancreatic diseases.
A total of 2075 patients (1197 male and 878 female, age range 26-93 years, mean age 64 years) who underwent diagnostic and therapeutic ERCP in our department from June 2001 to March 2009 were analyzed retrospectively. There were 1542 cases with choledocholithiasis, with 142 of these complicated with acute gallstone pancreatitis. There were 251 cases with tumors, including common bile duct tumor (n=83), carcinoma of the bile duct at the porta hepatis (n=54), carcinoma of the duodenal papilla (n=52), and carcinoma of the head of the pancreas (n=62). One hundred and twenty-four patients had benign bile duct stenosis, 69 had acute obstructive suppurative cholangitis, 8 had chronic pancreatitis, 1 had a foreign body in the pancreatic duct, 3 had iatrogenic bile duct injury, 4 had biliary tract roundworm, and 9 had choledochal cyst. The main clinical symptoms of the patients were as follows: upper abdominal pain, abdominal swelling, fever, jaundice, skin itching, and anorexia nervosa. Ultrasonic examination, computed tomography or magnetic resonance cholangiopancreatography of the liver, gallbladder, pancreas and spleen was performed for all the patients, and they were diagnosed or suspected of biliary-pancreatic diseases. Regular blood tests and serum amylase were examined.
The following instruments were used: electronic duodenoscope (Fujinon ED-450XT, Fujinon Company, Japan), high frequency electric of Wilson UES-30 (Erbe Company, Germany), needle knife (Olympus Company, Japan), opacification catheter (Boston Company, USA), Boston zebra guidewire (Boston Company), calculus-removing basket (Olympus Company), mechanical stone-breaking basket (Olympus Company), calculus-removing balloon (Cook Company, USA), bile duct and pancreatic duct plastic and metal self-expanding stent (Cook Company) for duct stenosis.
Fasting for no less than 6 hours was necessary for every patient. Patients were treated intravenously with 10 mg diazepam and 20 mg scopolamine butylbromide, and intramuscularly with 50 mg pethidine. Patients were in the prone position during the procedure, and straightened when the duodenoscope was inserted into the descending part of the duodenum to locate the papilla at the center of the visual field. Opacification was performed with a papillotome or catheter, and the pathological changes in the biliary-pancreatic duct were observed.
For the patients with common bile duct stones, endoscopic papillosphincterotomy (EST) and stone removal were undertaken. When the papillotome was inserted into the common bile duct, the papillary sphincter was cut along the 11-12 point, and after EST, the stone-removing basket or balloon was inserted into the common bile duct. If necessary, the mechanical stone-breaking basket was used if the stone was too big. According to each patient's condition, endoscopic nasobiliary drainage (ENBD) or endoscopic retrograde biliary drainage (ERBD) was performed if the stones could not be pulled on the first attempt.5-7 For the patients with acute gallstone pancreatitis, EST and common bile duct stone removal were performed. For the patients with benign and malignant obstruction of the biliary tract, a stent was inserted into the common bile duct as follows. A guidewire was inserted past the area of stenosis, a suitable size of dilating bougie was used to dilate the stenosis, the stent was inserted such that the upper part was located >1 cm beyond the stenosis, and the inferior part of the stent was placed in the duodenal lumen. If a metal stent was used, both sides should have been no less than 2 cm beyond the stenosis, and bile outflow from the stent demonstrated that the procedure was successful. For patients with acute obstructive suppurative cholangitis, stone removal, ENBD or ERBD was performed. For patients with chronic pancreatitis, according to the degree of pancreatic duct stenosis, endoscopic pancreatic sphincterotomy (EPS), bougie dilation, balloon dilation or endoscopic retrograde pancreatic drainage (ERPD) was performed. If there were pancreatic duct stones, then stone removal was performed.8-10 For patients with bile duct stenosis caused by iatrogenic bile duct injury, bougienage, balloon dilation or ERBD was performed.11 For patients whose pancreatic duct was filled with contrast medium, somatostatin was used to prevent the onset of pancreatitis.12 If necessary, pancreatic duct stenting or endoscopic nasopancreatic drainage (ENPD) was performed to prevent the onset of pancreatitis.13
Post-procedure observation and treatment
Fasting for 24 hours was necessary for all the patients who underwent ERCP. Serum amylase was tested at 3 and 24 hours after the procedure, and if amylase was normal, a liquid or semi-liquid diet was allowed to be taken. Antibiotics were used for 2-3 days in each patient to prevent inflammation. Early complications such as hyperamylasemia, pancreatitis, bile duct infection, bleeding and perforation, and the improvement of abdominal pain, jaundice, fever and other symptoms and signs, were observed.
In this study, 2075 patients were enrolled, 64 (3.1%) of them underwent diagnostic ERCP and 2011 (96.9%) underwent therapeutic ERCP. Among these, 1853 cases were successful, and the achievement rate was 94.6%. Among 1542 cases of choledocholithiasis, 1434 cases were successful, and the achievement rate was 93.0%. There were 1-15 stones in each patient, and the stone diameter ranged from 0.3 to 4.5 cm. Seven hundred and ninety-two patients had only one stone, and 642 had more than one stone, and 45 patients had stones with a diameter >3 cm. Thirteen patients had residual stones after T tube drainage, 68 had incarcerated stones in the duodenal papilla, 54 were complicated with internal duodenal fistula, and 684 were complicated with diverticulum beside the duodenal papilla. Stones in all 142 cases of acute gallstone pancreatitis were removed, and serum amylase decreased rapidly after treatment. The patients recovered after medical treatment (Figure 1). Roundworms were removed from the bile duct in 4 patients (Figure 2). Stone removal failed in 108 cases, 78 because of failure to insert the catheter, and 30 because the stones were too large and hard; these patients underwent surgery.
Four hundred and sixty-nine patients with benign or malignant bile duct obstruction, iatrogenic bile duct stenosis, acute obstructive suppurative cholangitis, or pancreatic duct stenosis, required stone removal on more than one occasion, and to prevent stone incarceration, they underwent stent placement or ENBD. In 422 of these cases, treatment was successful, and the achievement rate was 90.0% (Figure 3): 22 underwent metal stent placement in the bile duct; 286, plastic stent placement in the bile or pancreatic duct; and 114, ENBD. Double stents were placed in the left and right hepatic ducts in 25 patients with cancer of the bile duct at the porta hepatis. Double stents were placed in the bile and pancreatic ducts in 6 patients with ampullary carcinoma. Eight cases with chronic pancreatitis, among those 6 cases with pancreatic duct stenosis underwent endoscopic pancreatic sphincterotomy, 4 cases underwent bougie dilation, 2 cases underwent balloon dilation, 6 cases underwent ERPD. Two patients with pancreatic duct stones were treated successfully with stone removal. Treatment failed in 1 case with a foreign body in the pancreatic duct, because the foreign body was located at the tail of pancreas. Two patients underwent pancreatic duct stent placement to prevent the onset of pancreatitis. There was 1 case of cholangiocarcinoma that was treated by metal stent placement. Later, the metal stent was blocked and a plastic stent was inserted into the metal stent. The plastic stent was changed when it was blocked, and it lasted for 2 years, and the patient is still alive (Figure 4). Patients who failed treatment with ERCP underwent surgery or interventional therapy.
The treatment failed in 158 cases, among which, catheter placement failed in 132. The reasons for failure were as follows: tumor around the pars ampullaris, cholangiocarcinoma, duodenal papilla located in or around the diverticulum, constrictive type papilla caused by inflammation; 8 cases due to stenosis of the duodenal bulb or descendant duodenum, 18 cases had a Billroth II style remnant stomach, and the duodenal papilla could not be reached. Twelve patients who failed catheter placement underwent pre-cut of the papillary sphincter using a needle knife; 5 of them were successful, with an achievement rate of 62.5%. Sixty-five patients underwent EST, 59 of which were treated successfully, with an achievement rate of 90.8%.
There were complications in 105 cases (5.1%). Among these, 91 cases had pancreatitis, which was caused by the following: the catheter was inserted into the pancreatic duct several times; the pancreatic duct was filled with contrast medium several times; and bile duct catheterization was difficult. Eighty-four cases were mild acute pancreatitis, and 7 were severe acute pancreatitis. Among the latter, 6 cases were treated successfully with medical treatment, and 1 case that was further complicated with peritoneal abscess was treated successfully by surgery. Eight cases were complicated with bile duct infection, and they recovered with bile duct drainage and antibiotic treatment. Six cases were complicated with active bleeding after EST, which was controlled with endoscopic coagulation, noradrenaline spray and 1:10 000 adrenalin injection. No perforation and operative mortality occurred in this study.
ERCP is an important procedure for the diagnosis and treatment of biliary-pancreatic disease. ERCP can provide direct visualization and clear images of the bile and pancreatic ducts, and it has important diagnostic value for stones, tumor and stenosis in these ducts. However, ERCP is an invasive procedure and sometimes has serious complications; therefore, we should pay special attention to the choice of diagnostic ERCP. In the present study, there were 64 (3.1%) cases of diagnostic ERCP. We selected patients for diagnostic ERCP only when we suspected that there was biliary-pancreatic disease but no abnormal images were shown, to avoid unnecessary trauma for the patient. With the improvement of manipulation techniques and endoscopic accessories, therapeutic ERCP has advanced rapidly, and has become a therapeutic technique for biliary-pancreatic disease with micro-trauma. There were 2011 cases of therapeutic ERCP, the achievement rate was 94.6%, and the complication rate was 5.1%. Symptoms were relieved significantly after treatment, indicating that ERCP is a safe technique for the treatment of biliary-pancreatic disease, with a high achievement rate.
Choledocholithiasis is a frequent biliary disease. We performed EST and stone pulling in 1542 patients with common bile duct stones, with an achievement rate of 93.0%. Symptoms of abdominal pain, fever and jaundice were relieved rapidly when the stones were pulled out, and the average hospital stay was 3 days. There were often patients with large stones in the common bile duct, some of which were too large and hard to be removed. The mechanical breaking basket could not trap the stone, or even if the stone was trapped, because it was too hard, it could not be shattered. In the present study, there were 30 cases of large and hard stones in the common bile duct that failed treatment with ERCP, and they were treated surgically. In recent years, advances in mother-baby choledochoscopy have led to improvement of electrohydraulic and laser lithotripsy. Patients with large and hard stones in common bile duct can be treated with endoscopic therapy. In our study, 142 patients with acute gallstone pancreatitis underwent endoscopic stone removal. Serum amylase decreased rapidly after treatment, and they recovered with medical treatment. In 1978, Acosta et al demonstrated that the severity of acute gallstone pancreatitis was correlated positively with the period during which the duodenal ampulla was obstructed. All the pathological changes were reversible within 24 hours; between 24 and 48 hours, some bleeding and necrosis could be seen, and extensive bleeding and necrosis could be seen at beyond 48 hours. Therefore, emergency ERCP can relieve bile duct obstruction, and the key factor is that high-pressure bile cannot enter the pancreas.14 In our center, we perform emergency ERCP for all patients with acute gallstone pancreatitis; the onset of severe acute pancreatitis is reduced, and a good therapeutic effect is achieved.
For patients with benign and malignant bile duct stenosis, acute obstructive suppurative cholangitis and chronic pancreatitis complicated with biliary or pancreatic duct stenosis, stent placement is an effective procedure.15 Otherwise, to prevent residual stones after ERCP, ENBD or bile duct stenting is necessary. In our study, stent placement or ENBD was performed in 469 cases, 422 of which were successful, with an achievement rate of 90.0%. ENBD was used mainly to prevent residual stones, or if the patient needed another stone removal. It was also used in patients with acute obstructive suppurative cholangitis, complicated with acute cholecystitis, who had a high risk of pancreatitis after ERCP. After ENBD, the bile duct should remain unobstructed, which avoids papillary edema or stone incarceration, and therefore cholangitis and pancreatitis. Moreover, we found that in patients with bile duct obstruction complicated with acute cholecystitis, ENBD relieved symptoms of abdominal pain and fever. Perhaps this was related to the drainage of bile, which meant that less bile entered the gallbladder. Stenting was used mainly for patients with the following indications: benign or malignant bile duct or pancreatic duct obstruction; too large a bile duct stone that could not be removed with ERCP; and too large a stone that needed several attempts for removal. Stenting could keep the bile duct unobstructed. In patients with bile duct stones and serious complications that led to unstable vital signs, stenting could relieve symptoms. When the stent was inserted, symptoms of jaundice and abdominal pain were relieved significantly, and quality of life improved. Stent blockage is a problem. A plastic stent can be changed, but not a metal stent because it cannot be removed. This means that tumor tissue can grow within the mesh of a metal stent and cause blockage. An effective measure to combat this is to insert a plastic stent inside the metal stent. The causes of stent blockage can be bacterial adherence that leads to the formation of thick bile, blood clotting, tumor necrotic tissue, and tumor growth. Some advanced techniques to improve stent smoothness, prevent bacterial adherence, and inhibit tumor growth have been developed, which prolongs the period during which the stent remains unobstructed. This in turn reduces the rate of stent exchange, which leads to less suffering for the patient, and cost savings.
The achievement rate of ERCP in the present study was high, however, there were about 5%-10% of patients who failed treatment with the technique. Among the 158 cases of treatment failure, 132 (6.4%) failed because catheter placement was difficult. The reason for the failure of catheter placement was as follows: tumor obstruction at the duodenal ampulla; tumor invasion of the duodenal ampulla, which obscured the papilla; pancreatic head tumor led to twisting of the duodenal ampulla; hepatic hilum tumor and cholangiocarcinoma led to disuse atrophy of the duodenal ampulla; diverticulum of the descending duodenum resulted in bile duct deformation; stenosis of the papilla. Difficulty in bile duct insertion often had two explanations: one was that catheter could not be inserted into the duodenal papilla, and the other was that the guidewire went into the pancreatic duct repeatedly. In the first case, a pre-cut could be made with a needle knife. In the second case, a guidewire could be inserted into the pancreatic duct, and another guidewire is then inserted into the bile duct, or a pre-cut could be made with the trans-pancreatic duct method.16 Catalano et al17 have used the trans-pancreatic duct pre-cut method and had a 100% achievement rate, which was significantly higher than the 77% achievement rate with the needle knife pre-cut method. Moreover, the complication rate of the trans-pancreatic duct method was significantly less than that of the pre-cut method. In our center, the trans-pancreatic duct pre-cut method was used, and the achievement rate was 90.8%, which was close to the result of Goff18 (91%) and Liu et al (93%).19 Otherwise, Goldberg et al20 have used pancreatic duct stenting to assist the selective catheterization of the bile duct, and the achievement rate was 97.4%. In our center, we used pancreatic duct stenting in only 1 patient for successful catheterization of the bile duct, because this technique can increase the economic burden, and it is not used widely.
The most common complication for ERCP is acute pancreatitis, and others include bile duct infection, bleeding and perforation. The complication rate in our study was 5.1%, and the most common complication was acute pancreatitis (4.4%). Patients complicated with acute pancreatitis often had the following characteristics: multiple contrast medium filling of the pancreatic duct, and difficult bile duct catheterization, which have both been demonstrated as major reasons for acute pancreatitis. To prevent acute pancreatitis after ERCP, reduce the time for pancreatic duct catheterization, and avoid pancreatic duct visualization, the velocity of contrast medium agent injection and guidewire insertion into the pancreatic duct should be performed carefully, and long-term repeat catheterization should be avoided. If the guidewire was inserted several times into the pancreatic duct or if the duct was visualized, preventive use of somatostatin was necessary, along with pancreatic duct stent placement or ENPD. Other reasons for acute pancreatitis after ERCP included injury to the pancreatic duct during EST, excessive coagulation, and residual stones, which lead to swelling of the papilla; therefore, coagulation current should be avoided during EST. Sato et al21 and Ma et al22 have used ENBD after stone pulling, and no acute pancreatitis occurred. ENBD can prevent residual stones and papillary swelling.
ERCP was used widely for treatment of biliary-pancreatic disease, but some problems remain, for example, the treatment of large stones, and stent obstruction. Advances in mother-baby choledochoscopy, electrohydraulic and laser lithotripsy, and the production of special stents could all promote the development of ERCP.23-25 We continue to pursue a high success and low complication rate for ERCP.
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