Impact of Pancreatic and Biliary Stent on Post-Endoscopic Papillectomy Complications: A Single-Center Retrospective Study
Endoscopic papillectomy (EP) has emerged as the first-line therapy for ampullary tumors due to its minimally invasive nature, favorable treatment outcomes, and lower cost compared to surgical resection. Despite its advantages, EP is associated with a relatively high incidence of complications, particularly post-procedural pancreatitis and hemorrhage. To mitigate these risks, prophylactic placement of pancreatic and/or biliary stents is often employed. However, the efficacy of different stent types in preventing post-EP complications remains a subject of debate. This study aims to evaluate the impact of pancreatic and biliary stents on post-EP complications and identify potential risk factors for these adverse events.
Background and Rationale
Ampullary tumors are relatively rare, with a prevalence of only 0.04–0.12% in autopsy studies. These tumors account for approximately 5% of all gastrointestinal tumors. The detection rate of ampullary tumors has increased in recent years due to the widespread use of esophagus-gastroduodenoscopy and endoscopic retrograde cholangiopancreatography (ERCP). Complete resection of ampullary tumors is typically recommended due to the high risk of malignancy, which ranges from 26% to 65% according to the adenoma–adenocarcinoma sequence. Moreover, complete resection is necessary because of the poor diagnostic accuracy of pre-procedural endoscopic biopsies, which have false-negative rates of up to 30% and diagnostic discrepancies in post-procedural pathologic results ranging from 38.3% to 85%.
EP has been widely adopted as a less invasive alternative to surgical resection for ampullary adenomas and early-stage tumors. However, EP is still considered a high-risk procedure due to its non-negligible complication rate, which ranges from 6.1% to 58.3%. Post-procedural pancreatitis is one of the most common and potentially lethal complications, occurring in 3.8% to 33% of patients. Although most cases are mild to moderate, post-procedural pancreatitis can lead to prolonged hospital stays, invasive interventions, increased medical costs, and even life-threatening conditions.
Prophylactic pancreatic stent placement has been recommended in international expert consensus and guidelines to prevent post-EP pancreatitis. Pancreatic stents are thought to improve intra-pancreatic duct pressure and prevent pancreatic duct stenosis caused by papillary edema and scarring. However, pancreatic stent placement is technically challenging, even for experienced endoscopists, and repeated cannulation attempts can increase the risk of pancreatitis. As a result, biliary stent placement is often considered an alternative, especially when pancreatic cannulation is difficult. Some experts also prefer to place both pancreatic and biliary stents, although the efficacy of this approach remains unclear.
Study Objectives
This study aims to evaluate the efficacy of prophylactic pancreatic and/or biliary stent placement in preventing post-EP pancreatitis and other complications. Additionally, the study seeks to identify potential risk factors for post-EP pancreatitis and hemorrhage.
Methods
Patient Population
A total of 117 patients who underwent EP between June 2006 and October 2022 at the endoscopy center of the First Medical Center of Chinese PLA General Hospital were retrospectively enrolled in this study. Patients were excluded if they had a history of ampullary tumor treatment, did not receive stent placement, or underwent a novel EP procedure with wound surface protection using metal clips and fibrin glue. Based on the type of stents placed, patients were divided into three groups: the pancreatic stent group (PS group, n = 47), the biliary stent group (BS group, n = 38), and the two-stent group (PBS group, n = 32).
Endoscopic Papillectomy Procedure
All EP procedures were performed under intravenous anesthesia using a single-channel gastroscope, snare, high-frequency generator, and argon plasma coagulation (APC) unit. Carbon dioxide insufflation was used during the procedure. Submucosal injection with diluted epinephrine was performed at the discretion of the endoscopist. The ampullary lesion was snared at the base using a polypectomy snare, and constant tension was applied to transect the lesion. En bloc resection was attempted in all patients, but piecemeal resection was performed for large adenomas or grossly remnant lesions. APC and forceps were used for small residual tumors to ensure therapeutic success. Endoscopic sphincterotomy and pancreatic and/or biliary stents were placed at the endoscopist’s discretion. Hemostasis was achieved using electric coagulation, saline solution with epinephrine, APC, and clips. Stent placement was confirmed under X-ray.
Post-Procedural Management
After the procedure, patients were admitted for close observation and maintained on therapeutic fasting. All patients received proton pump inhibitors, antibiotics, and somatostatin for 1–3 days. Bile/pancreatic stents were removed within three months if no significant papillary stricture was observed. Endoscopic follow-up was scheduled at 3, 6, and 12 months for the first year and then yearly for the following five years.
Outcomes and Definitions
The primary outcome was the development of post-EP pancreatitis, defined as clinical pancreatitis meeting two of the following three criteria: pain consistent with acute pancreatitis, amylase or lipase levels more than three times the upper normal limit, and characteristic imaging findings. The severity of pancreatitis was graded as mild, moderate, or severe based on the Revised Atlanta International consensus. Secondary outcomes included the incidence of other post-EP complications (hemorrhage, perforation, and biliary stenosis) and transient adverse events (TAEs, such as fever and hyperamylasemia). Hemorrhage was defined as a progressive drop in hemoglobin or active bleeding found during postoperative or follow-up endoscopy.
Statistical Analysis
Continuous variables were presented as mean ± standard deviation or median (interquartile range), while categorical variables were presented as frequencies and percentages. Comparisons among groups were performed using Student’s t-tests, analysis of variance, Wilcoxon rank sum tests, or Kruskal-Wallis H tests, as appropriate. Categorical variables were compared using chi-squared analysis or Fisher’s exact test. Multivariate logistic regression analysis was used to identify independent risk factors for post-EP pancreatitis and hemorrhage. Variables with a P value of <0.10 in univariate analysis were included in the multivariate model. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Statistical significance was set at P < 0.05.
Results
Patient Characteristics
The median tumor size was 1.5 cm, and en bloc resection was achieved in 84.6% of patients. R0 resection was achieved in 70.9% of patients. The median procedural time was 40 minutes, and the median postoperative hospital stay was nine days. Significant differences were observed among the three groups in the usage rates of sphincterotomy, metal clips, and epinephrine, as well as in tumor size and procedural time.
Complications and Adverse Events
The overall incidence of post-EP complications was 37.6%, with pancreatitis and hemorrhage being the most common complications, occurring in 14.5% and 17.9% of patients, respectively. The incidence rates of post-EP pancreatitis were 10.6% in the PS group, 23.7% in the BS group, and 9.4% in the PBS group, with no significant differences among the groups. Similarly, there were no significant differences in the incidence of other complications or TAEs among the three groups.
Risk Factors for Post-EP Pancreatitis
Univariate analysis identified age as significantly associated with post-EP pancreatitis. Multivariate logistic regression analysis confirmed that older age was an independent protective factor for post-EP pancreatitis (OR: 0.95; 95% CI: 0.91–0.99; P = 0.022).
Risk Factors for Post-EP Hemorrhage
Univariate analysis identified tumor size and procedural time as significantly associated with post-EP hemorrhage. Multivariate logistic regression analysis revealed that larger tumor size was an independent risk factor for post-EP hemorrhage (OR: 1.66; 95% CI: 1.06–2.60; P = 0.028).
Discussion
This study found no significant differences in the incidence of post-EP pancreatitis and other complications among patients who received pancreatic stents, biliary stents, or both. While pancreatic stenting remains the first choice for preventing post-EP pancreatitis, biliary stenting may be a viable alternative for patients with difficulties in pancreatic cannulation. The placement of both pancreatic and biliary stents appears unnecessary unless required for other concerns.
Older age was identified as an independent protective factor for post-EP pancreatitis, likely due to the physical decay of pancreatic exocrine function with age. Larger tumor size was identified as an independent risk factor for post-EP hemorrhage, consistent with previous studies. These findings highlight the importance of identifying high-risk patients and tailoring post-EP management strategies accordingly.
Limitations
This study has several limitations. First, its retrospective design may have introduced selection bias and excluded potential risk factors. Second, the single-center nature of the study may limit the generalizability of the results. Third, the exclusion of patients without stent placement may have influenced the findings. Future research should adopt a multicenter, prospective design to address these limitations.
Conclusion
In conclusion, while pancreatic stenting is the preferred method for preventing post-EP pancreatitis, biliary stenting can be considered as an alternative for patients with difficulties in pancreatic cannulation. The placement of both pancreatic and biliary stents is generally unnecessary unless required for other reasons. Identifying high-risk patients and implementing tailored management strategies can help reduce the incidence of post-EP complications.
doi.org/10.1097/CM9.0000000000002893
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