Photodynamic therapy in unresectable cholangiocarcinoma: not for the uncommitted.

BACKGROUND/AIMS: Photodynamic therapy (PDT) in unresectable cholangiocarcinoma has been associated with improved survival. We report a single tertiary care center experience over the past 6 years. METHODS: Fifty-five patients with unresectable cholangiocarcinoma received PDT between 2004 and 2010. Plastic stents were placed after PDT to prevent cholangitis. RESULTS: Twenty-seven patients (49%) showed Bismuth type IV, 22 (41%) showed Bismuth type III, and six (10%) showed Bismuth type I and II. Twenty patients (37%) received chemotherapy and radiation therapy, five (9%) received chemotherapy only; and one (2%) received radiation therapy only. Mean number of PDT sessions was 1.9±1.5 sessions (range, 1 to 9). Mean survival duration was 293±266 days (median, 190; range, 25 to 1,332). PDT related complications included three (5%) facial burn, three (5%) photosensitivity, and two (3%) rash. Kaplan-Meier analysis comparing the survival means of patients who received PDT and chemotherapy/radiation therapy (median survival 257 days; 95% confidence interval [CI], 166 to 528) versus who received PDT only (median survival 183 days; 95% CI, 129 to 224) showed no significant difference (log-rank p=0.20). CONCLUSIONS: PDT has a measurable impact on survival in unresectable cholangiocarcinoma but requires aggressive stenting posttherapy.

Safety and efficacy of radiofrequency ablation in the management of unresectable bile duct and pancreatic cancer: a novel palliation technique.

UNLABELLED: Objectives. Radiofrequency ablation (RFA) has replaced photodynamic therapy for premalignant and malignant lesions of the esophagus. However, there is limited experience in the bile duct. The objective of this pilot study was to assess the safety and efficacy of RFA in malignant biliary strictures. METHODS: Twenty patients with unresectable malignant biliary strictures underwent RFA with stenting between June 2010 and July 2012. Diameters of the stricture before and after RFA, immediate and 30 day complications and stent patency were recorded prospectively. Results. A total of 25 strictures were treated. Mean stricture length treated was 15.2 mm (SD = 8.7 mm, Range = 3.5-33 mm). Mean stricture diameter before RFA was 1.7 mm (SD = 0.9 mm, Range = 0.5-3.4 mm) while the mean diameter after RFA was 5.2 mm (SD = 2 mm, Range = 2.6-9 mm). There was a significant increase of 3.5 mm (t = 10.8, DF = 24, P value = <.0001) in the bile duct diameter post RFA. Five patients presented with pain after the procedure, but only one developed mild post-ERCP pancreatitis and cholecystitis. CONCLUSIONS: Radiofrequency ablation can be a safe palliation option for unresectable malignant biliary strictures. A multicenter randomized controlled trial is required to confirm the long term benefits of RFA and stenting compared to stenting alone.

Multimodality endoscopic treatment of pancreatic duct disruption with stenting and pseudocyst drainage: how efficacious is it?

BACKGROUND: Few studies have described the role of multimodality therapy and the complexity of endoscopic management of pancreatic duct disruption. Our study aim was to analyse and confirm factors associated with the resolution of pancreatic duct disruption. METHODS: Over 6 years, retrospective data on patients with pancreatic duct disruption managed endoscopically were retrieved. Success was defined as resolution of the pancreatic duct disruption at 12 months. Logistic regression analysis was performed to determine factors associated with resolution. RESULTS: 113 patients (78 male) with a mean age 51.3 year were included. Resolution of the pancreatic duct leak occurred in 80 cases (70.2%). 72 cases received transpapillary pancreatic duct stents, with 51 demonstrating resolution of pancreatic duct leak (71%) cystenterostomy was performed in 68 patients with 51 resolved (75%). In partial duct disruptions, pancreatic duct stenting combined with endoscopic drainage of fluid collections resulted in an increased rate of resolution (80%) compared to complete disruptions treated in a similar manner (57%). In complete pancreatic ductal disruptions, transpapillary pancreatic duct stenting had no additional benefit (9/17, 52.9%) compared to cystenterostomy or percutaneous drainage alone (24/34, 70.6%; P=0.61). CONCLUSION: Pancreatic duct disruptions require multimodality treatment, addressing not only the integrity of the pancreatic duct but also any fluid collections associated. Partial ductal disruption should be managed by a bridging stent.

Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) of the Pancreas in a Porcine Model.

Backgrounds. Limited effective palliative treatments exist for pancreatic cancer which includes surgery or chemotherapy. Radiofrequency ablation (RFA) uses high frequency alternating current to ablate diseased tissue and has been used to treat various tumors. In this study, we evaluated a prototype probe adjusted to the EUS-needle to perform EUS-RFA to permit coagulative necrosis in the pancreas. Methods. Five Yucatan pigs underwent EUS-guided radiofrequency ablation of the head of their pancreas. Using an EUS-needle, RFA was applied with 6 mm and then 10 mm of the probe exposed at specific wattage for preset durations. Results. Only one pig showed moderate levels of pancreatitis (20% proximal pancreatitis). The other animals showed much lower areas of tissue damage. In 3 of the 5 pigs, the proximal pancreas showed greater levels of tissue injury than the distal pancreas, consistent with the proximity of the tissue to the procedure site. In 1 pig, both proximal and distal pancreas showed minimal pancreatitis (1%). There was minimal evidence of fat necrosis in intra-pancreatic and/or extra-pancreatic adipose tissue. Conclusion. EUS-guided RFA of the pancreatic head with the monopolar probe through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimal amount of pancreatitis.

Percutaneous gastrostomy tube placement to perform transgastrostomy endoscopic retrograde cholangiopancreaticography in patients with Roux-en-Y anatomy.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) surgery is one of the most commonly performed bariatric surgeries in the United States. Patients with prior RYGB are not amenable to conventional endoscopic retrograde cholangiopancreaticography (ERCP). Surgical gastrostomy (SG) tube placement enables transgastrostomy ERCP (TG-ERCP). MATERIALS AND METHODS: Eleven patients with RYGB anatomy received open Stamm gastrostomy after which the tract was then allowed to mature for an average of 45 days before therapeutic TG-ERCP. The success rate and procedure-related complications of both gastrostomy and ERCP were assessed. RESULTS: TG-ERCP was performed on eleven patients (median age 52 years, range 37-61 years) with prior RYGB and pancreatobiliary diseases. Indications for ERCP in these patients included suspected gallstone pancreatitis (n = 4), ampullary/biliary strictures (n = 5), pancreas divisum (n = 1), and common bile duct clipping as a result of RYGB surgery (n = 1). Two individuals developed post surgical complications with stomal-related infections. TG-ERCP with therapeutic intervention was successfully performed in all patients. Intervention included stone extractions (n = 11), biliary stricture dilation (n = 11), biliary sphincterotomy (n = 11), biliary (n = 3) and pancreatic (n = 1) stent placement, ampullary biopsies (n = 3), choledochoscopy (n = 1), and pseudocyst drainage (n = 1). Complications included post-ERCP pancreatitis (n = 2), post-sphincterotomy bleeding (n = 1), gastrostomy site bleed (n = 1), and gastric perforation (n = 1). The total number of ERCP sessions for the eleven patients was 15 (1 or 2 per patient). Median follow-up was 42 days (range 7-123 days). CONCLUSION: Surgical open gastrostomy followed by TG-ERCP enables therapeutic intervention but is associated with significant complications.

Fully-covered, self-expandable metal stents (CSEMS) in malignant distal biliary strictures: mid-term evaluation.

BACKGROUND AND AIMS: Limited data exist regarding fully-covered, self-expandable metal stents (CSEMS) with anchoring fins for the management of malignant distal biliary strictures. The aim of this study is to evaluate their safety and patency. METHODS: Over a period of 2 years, 70 patients (45 males, 66 ± 13 years) underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of a 10-mm (67 patients) or 8-mm diameter (3 patients) CSEMS for the palliation of distal malignant biliary obstruction (pancreatic [53] or other [17]). Data were collected prospectively for survival and stent patency; complications were evaluated retrospectively. RESULTS: After CSEMS placement, 17 patients proceeded to surgery, and 53 patients were deemed unresectable. Mean survival for non-surgical candidates was 180 days (range: 15-1091), and 170 days (range: 9-589) for patients who underwent surgical management. CSEMS were left in place and remained patent for a mean of 163 days (range: 15-1091) in non-surgical candidates, and a mean of 55 days (range: 5-126) in surgical candidates. Complications during placement included wire perforations (4) and proximal deployment requiring repositioning (4), one of which was complicated by a bile leak. Post-procedure complications were observed in 24 cases (34%) and included post-ERCP pancreatitis (8, with 2 of them severe), post-procedure pain (5, with 3 requiring admission), cholecystitis (3), stent occlusion (3), cholangitis (2), proximal migration (1), post-sphincterotomy bleeding (1), and sepsis leading to death (1). CONCLUSION: CSEMS appear to provide acceptable short-term patency rates; however, their limited long-term patency and high complication rate might limit their widespread use. Further long-term prospective data are required to confirm this observation.

Single-balloon enteroscopy effectively enables diagnostic and therapeutic retrograde cholangiography in patients with surgically altered anatomy.

BACKGROUND: In patients with surgically altered anatomy, ERCP is often unsuccessful. Single-balloon enteroscopy (SBE) enables deep intubation of the small bowel, permitting diagnostic and therapeutic ERCP in this subset of patients. OBJECTIVE: To determine the effectiveness of SBE in performing endoscopic retrograde cholangiography (ERC) in patients with surgically altered anatomy. DESIGN: Case series. SETTING: Large quaternary-care center. PATIENTS: Thirteen patients (11 women) underwent 16 SBE procedures with ERCP. Patient anatomy consisted of Whipple (n = 3), hepaticojejunostomy (n = 3), Billroth II (n = 1), and Roux-en-Y (n = 9). INTERVENTIONS: Patients with surgically altered anatomy in whom standard ERCP techniques had failed or were not possible underwent ERC by using SBE with initial therapeutic intent. MAIN OUTCOME MEASUREMENTS: Success rates of diagnostic ERC and therapeutic ERC in those patients who required biliary intervention. Procedure-related complications were also assessed. RESULTS: Diagnostic ERC was successful 12 (92.3%) of 13 patients and in 13 (81.3%) of 16 cases. Therapeutic ERC was required in 10 patients in whom diagnostic ERC was first accomplished, and therapeutic ERC was successful in 9 (90%) of 10 patients. Biliary interventions included balloon dilation (n = 4), stone extraction (n = 2), sphincterotomy (n = 4), removal of a surgically placed stent (n = 3), and stenting (n = 2). Two patients developed pancreatitis after therapeutic ERC. Median follow-up was 53 days (range 22-522 days). Overall procedural success in an intent-to-treat analysis by case was 75%. LIMITATION: Single-center experience. CONCLUSION: SBE enables diagnostic and therapeutic ERC in most patients with altered anatomy. SBE-assisted therapeutic ERC may be associated with an increased risk of pancreatitis. Improvement of the available equipment is necessary to perform more efficient and effective biliary interventions.

Mortality in patients undergoing covered self-expandable metal stent revisions in malignant biliary stricture: does pathology matter?

BACKGROUND AND AIMS: Partially covered metal stents have been extensively used for palliation of obstructive jaundice in malignant distal biliary strictures and can be removed in cases of malfunction or need for tissue diagnosis. We investigated independent predictors of mortality in patients undergoing partially covered metal stents revision (i.e., removal and replacement). METHODS: Patients with a distal malignant biliary obstruction palliated with a partially covered metal stent were followed-up prospectively over 5 years until malfunction or death. All patients who required removal of their partially covered metal stents were captured in a specific database. Multivariate analysis was performed on non-surgical patients to assess for independent predictors of death using known risk factors including type of malignancy (adenocarcinoma versus all others), age greater than 55, gender, and exposure to adjuvant chemotherapy and/or radiotherapy. RESULTS: Forty-two patients (28 men, mean age of 62±12 years) underwent partially covered metal stents removal. Of these, biliary drainage was achieved in 38 patients by placement of a new partially covered metal stent (n=32) or plastic stent (n=6). The remaining 4 patients did not undergo stent replacement because of refusal (2), resolution of obstruction (1) and unrelated death (1). Long-term follow-up post removal in patients who were not surgical candidates (n=31) was 35 weeks (95% CI 28-40), with a survival rate of 29% at 10 months. Logistic regression analysis in the 31 patients with unresectable disease showed that a histologic diagnosis of adenocarcinoma was associated with increased mortality post partially covered metal stents revision. CONCLUSIONS: Partially covered metal stents revision should be undertaken especially when dealing with a non-adenocarcinoma type cancer.

Gallbladder stent placement for prevention of cholecystitis in patients receiving covered metal stent for malignant obstructive jaundice: a feasibility study.

PURPOSE: Covered self-expanding metal stents (CSEMS) have been used for palliation of malignant distal biliary strictures. Occlusion of the cystic duct by CSEMS may be complicated by cholecystitis. This potentially could be prevented by placement of a transpapillary gallbladder stent (GBS). PATIENTS AND METHODS: Between 11/2006 and 10/2007, a total of 73 patients (50 male) aged 65 +/- 14 years underwent CSEMS placement for palliation of malignant obstructive jaundice. In cases where CSEMS placement caused occlusion of the cystic duct, a 7 French transpapillary pigtail gallbladder stent (GBS) was inserted to prevent cholecystitis. RESULTS: Of the 73 patients, 18 had a prior cholecystectomy; 34 had the CSEMS placed below the cystic duct insertion. In 19 out of the 21 patients who had a CSEMS covering the cystic duct ostium, GBS placement was attempted, which was successful in 11 individuals (58%). An attempt to access the gallbladder was complicated by wire perforation of the cystic duct in three patients; one patient requiring emergent cholecystostomy tube placement. None of the patients who underwent successful GBS placement developed cholecystitis. One GBS dislodged and was repositioned. Cholecystitis occurred in two (20%) of the ten patients without transpapillary gallbladder decompression who had a CSEMS covering the cystic duct. CONCLUSIONS: The ideal placement of a CSEMS is below the cystic duct insertion. Should the cystic duct ostium be occluded, placement of a GBS should be considered to minimize the risk of cholecystitis.

Management of complications associated with partially covered biliary metal stents.

BACKGROUND: Partially covered metal stents (PCMS) have been increasingly used for both malignant and benign biliary indications. This study reports their complications and subsequent management. METHODS: Over 5 years, all patients receiving biliary PCMS were followed prospectively until stent-related dysfunction or death. Data were analyzed for the following variables: primary disease, time until revision, and type and reason for revision. RESULTS: PCMS were placed in 396 patients (247 with malignant biliary strictures and 149 with benign biliary disease). Complications were observed in 70 patients (18%), occurring a mean time following placement of 159 days. Duodenal migration occurred in 27 cases (6.8%), while proximal migration occurred in 9 cases (2.3%). Cholecystitis was documented in 13 cases (3.3%). There were six cases of stent occlusion due to debris or sludge (1.6%), four cases of pancreatitis (1%), four cases of tumor overgrowth (1%), three cases of benign stenosis in the uncovered portion of the PCMS (0.8%), two cases of abdominal pain (0.5%), one case of an infected biloma (0.3%), and one case of a liver abscess (0.3%). CONCLUSIONS: Major complications associated with PCMS placement include migration and cholecystitis. Their management includes endoscopic revision, cholecystectomy, and gallbladder drainage. Further improvements in the structure and composition of PCMS may prevent these complications.

Effect of pancreatic duct stent diameter on hospitalization in chronic pancreatitis: does size matter?

OBJECTIVE: Endoscopic therapy with pancreatic duct (PD) stenting in painful chronic pancreatitis is effective at reducing pain. Few studies have compared response to different PD stent diameters. In this study, we retrospectively analyzed the effect of PD stent diameter on hospitalization for abdominal pain in chronic pancreatitis. METHODS: An existing database was queried to identify individuals who received PD stenting for chronic pancreatitis. Each patient was grouped according to stent diameter: (1) 8.5F stents or smaller and (2) 10F stents. The main outcome was number of hospitalizations adjusting for varying follow-up time and controlling for age, sex, and etiology of pancreatitis using a negative binomial model. RESULTS: One hundred sixty-three patients underwent PD stent placement for chronic pancreatitis from October 1995 to September 2007. One hundred twenty-nine patients (79%) received predominantly PD stents 8.5F or smaller in diameter, and 34 patients (21%) received predominantly PD stents 10F in diameter. There was no statistically significant difference in population characteristics between the 2 groups. The 10F stent group had a statistically significant (P = 0.003) lower rate of hospitalization. CONCLUSIONS: Patients who received larger diameter PD stents had fewer hospitalizations for abdominal pain. Outcome-based prospective studies are needed.

Temporary placement of fully covered self-expandable metal stents in benign biliary strictures: midterm evaluation (with video).

BACKGROUND: Benign biliary strictures (BBS) have been endoscopically managed with placement of multiple plastic stents. Uncovered metal stents have been associated with mucosal hyperplasia and partially covered self-expandable metal stents with migration. Recently, fully covered self-expandable metal stents (CSEMSs) with anchoring fins have become available. OBJECTIVE: Our purpose was to analyze the efficacy and complication rates of CSEMSs in the treatment of BBS. DESIGN: CSEMSs (10-mm diameter) were placed in 44 patients with BBS. CSEMSs were left in place until adequate biliary drainage was achieved, confirmed by resolution of symptoms, normalization of liver function tests, and imaging. SETTING: Tertiary care center with long-standing experience with metal stents. PATIENTS: A total of 44 patients with BBS (28 men, median age 53.5 years) were included. The preprocedure diagnoses included chronic pancreatitis (n = 19), gallstone-related strictures (n = 14), post liver transplant (n = 9), autoimmune pancreatitis (n = 1), and primary sclerosing cholangitis (n = 1). INTERVENTION: ERCP with temporary CSEMS placement. Removal of CSEMSs was performed with a snare or rat tooth. MAIN OUTCOME MEASUREMENTS: Stricture resolution and morbidity. RESULTS: The median time of CSEMS placement was 3.3 months (interquartile range 3.0-4.8). Resolution of the BBS was confirmed in 34 of 41 patients (83%) after a median postremoval follow-up time of 3.8 months (interquartile range 1.2-7.7). Complications were observed in 6 (14%) patients after CSEMS placement and in 4 (9%) after CSEMS removal. LIMITATION: Pilot study from a single center. CONCLUSION: Temporary placement of CSEMSs for BBS may offer an alternative to plastic stenting. Further investigation is required to further assess safety and long-term efficacy.

Temporary placement of a fully covered self-expandable metal stent in the pancreatic duct for management of symptomatic refractory chronic pancreatitis: preliminary data (with videos).

BACKGROUND: Pancreatic duct (PD) stenting is beneficial for the treatment of pain in patients with PD strictures associated with chronic pancreatitis. Placement of metal stents has been reported but failed secondary to hyperplasia or migration. OBJECTIVE: To investigate the outcome of patients with symptomatic and refractory PD strictures who had temporary placement of a covered self-expandable metal stent (CSEMS). DESIGN: Patients with refractory PD strictures were offered temporary CSEMS placement. Pain scores were evaluated before and after CSEMS placement. SETTING: A tertiary-care center. PATIENTS: Six patients (4 men, mean age +/- SD 55 +/- 8 years) received a CSEMS, and 5 patients had removal of a CSEMS after a mean time of 92 days. INTERVENTION: Placement of CSEMS (8-mm or 10-mm diameter VIABIL) in the PD, with removal after 3 months. MAIN OUTCOME MEASUREMENTS: The pain score before and after stent placement and the sustained response after removal. Morbidity associated with stent placement and removal was also noted. RESULTS: Pain scores after CSEMS placement significantly improved (P = .024), from 6.4 to 1.6. Of the 5 patients who underwent CSEMS removal, 3 developed recurrent symptomatic pancreatic stricture, of whom 2 required repeat stenting with a larger-diameter CSEMS (10 mm) and 2 remained pain free. The CSEMS was not removed in 1 patient because pancreatic malignancy was diagnosed. There were no complications during placement or removal of CSEMSs. LIMITATION: This was a pilot study. CONCLUSION: Temporary placement of CSEMSs in patients with symptomatic refractory PD stricture offers transient relief of pain. Further investigation is needed to determine the optimal diameter and duration of placement.

Transenteric drainage of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video).

BACKGROUND: Drainage of pancreatic-fluid collections (PFCs) by using fully covered self-expanding metallic stents (CSEMSs) offers the option of providing a larger-diameter access fistula for drainage when compared with plastic stents. OBJECTIVE: To evaluate the efficacy and safety of transenteric drainage of PFCs by using CSEMSs. DESIGN: A prospective case series. SETTING: A tertiary-referral center. PATIENTS: Between January 2007 and September 2007, 18 patients underwent drainage of PFCs by using CSEMSs. Follow-up and final results were prospectively recorded until May 2008. INTERVENTIONS: Placement of CSEMSs with a double-pigtail stent placed alongside (4 cases) or into the CSEMS (14 cases) to prevent migration. MAIN OUTCOME MEASUREMENTS: The number of sessions and time to resolution of the PFCs. RESULTS: A median of 1 session was required to achieve drainage (range 1-4) when using CSEMSs. Complications included superinfection (5), bleeding (2), and inner migration (1). A total of 17 of 18 patients (95%) responded successfully, with 14 patients (78%) achieving complete resolution of their PFC. The mean (+/- SD) time of follow-up until final resolution was 77 +/- 80 days (range 15-310 days). CONCLUSIONS: Placement of CSEMSs seems to offer an effective and safe alternative for the drainage of PFCs. A randomized controlled trial should be performed to compare this technique with plastic-stent drainage.

Enteral stents for malignancy: a report of 46 consecutive cases over 10 years, with critical review of complications.

BACKGROUND: Current management of malignant gastric outlet obstruction (GOO) includes surgical diversion or enteral stent placement for unresectable cancer. We analyzed the long-term results, predictive factors of outcomes, and complications associated with enteral stents with focus on their management. METHODS: Between 1997 and 2007, 46 patients with malignant GOO underwent placement of self-expandable metal stents (SEMS) for palliation. Patients were captured prospectively after 2001 and followed until complication or death. Patency, management of complications, and long-term survival were analyzed. RESULTS: Forty-six patients had a mean survival of 152 +/- 235 days and a mean SEMS patency rate of 111 +/- 220 days. SEMS patency rates of 98%, 74%, and 57% at 1, 3, and 6 months were seen. Thirteen patients presented with obstruction and included two SEMS migration, two early occlusion, one fracture, four malignant ingrowth, and four with delayed clinical failure. Interventions included seven endoscopic revisions with three SEMS replacements. Six had percutaneous endoscopic gastrostomy with jejunal arm placed. Two patients eventually underwent surgical bypass. Two patients required surgery for complications including delayed duodenal perforation and aortoenteric fistula. CONCLUSIONS: SEMS effectively palliate gastric outlet obstructions that result from upper gastrointestinal malignancies. Their benefits offset potential complications or malfunctions, when a pluridisciplinary approach is adopted.

Unresectable cholangiocarcinoma: comparison of survival in biliary stenting alone versus stenting with photodynamic therapy.

BACKGROUND & AIMS: Photodynamic therapy (PDT) for unresectable cholangiocarcinoma is associated with improvement in cholestasis, quality of life, and potentially survival. We compared survival in patients with unresectable cholangiocarcinoma undergoing endoscopic retrograde cholangiopancreatography (ERCP) with PDT and stent placement with a group undergoing ERCP with stent placement alone. METHODS: Forty-eight patients were palliated for unresectable cholangiocarcinoma during a 5-year period. Nineteen were treated with PDT and stents; 29 patients treated with biliary stents alone served as a control group. Multivariate analysis was performed by using Model for End-Stage Liver Disease score, age, treatment by chemotherapy or radiation, and number of ERCP procedures and PDT sessions to detect predictors of survival. RESULTS: Kaplan-Meier analysis demonstrated improved survival in the PDT group compared with the stent only group (16.2 vs 7.4 months, P<.004). Mortality in the PDT group at 3, 6, and 12 months was 0%, 16%, and 56%, respectively. The corresponding mortality in the stent group was 28%, 52%, and 82%, respectively. The difference between the 2 groups was significant at 3 months and 6 months but not at 12 months. Only the number of ERCP procedures and number of PDT sessions were significant on multivariate analysis. Adverse events specific to PDT included 3 patients with skin phototoxicity requiring topical therapy only. CONCLUSIONS: ERCP with PDT seems to increase survival in patients with unresectable cholangiocarcinoma when compared with ERCP alone. It remains to be proved whether this effect is attributable to PDT or the number of ERCP sessions. A prospective randomized multicenter study is required to confirm these data.