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ORIGINAL ARTICLE
Year : 2020  |  Volume : 16  |  Issue : 5  |  Page : 1119-1124

Should the Oddis sphincter be retained? A clinical analysis of biliary metal stent implantation in patients with malignant obstructive jaundice


Department of Interventional Treatment, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, China

Date of Submission25-Feb-2020
Date of Decision12-May-2020
Date of Acceptance09-Jul-2020
Date of Web Publication29-Sep-2020

Correspondence Address:
HaiPeng Yu
Department of Interventional Treatment, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi, Tianjin 300060
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcrt.JCRT_220_20

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 > Abstract 


Objective: We sought to analyze the efficacy and safety of preserving the Oddis sphincter during metallic biliary stent implantation in patients with malignant obstructive jaundice.
Materials and Methods: In a retrospective analysis, 133 patients with malignant obstructive jaundice who were admitted to our hospital from January 2010 to January 2017 and who underwent metallic biliary stent implantation were divided into two groups – the Oddis sphincter retention group (n = 55) and the Oddis sphincter nonretention group (n = 78) – according to whether the Oddis sphincter was left untouched during stent placement. The patient clinical data as well as information on complications, time of stent patency, improvement in liver function, and decline of serum bilirubin were reviewed and evaluated. Statistical analysis was performed using the Statistical Package for the Social Sciences version 19.0 (IBM Corp., Armonk, NY, USA, USA) and Prism version 7 (GraphPad Software, San Diego, CA, USA).
Results: The median follow-up time was 9.6 months (range: 1–20 months) and there was no significant difference in general clinical information between the two groups. However, the incidence rates of acute biliary infection, recurrent biliary infection, acute pancreatitis, chronic pancreatitis, and asymptomatic pancreatic enzyme levels were higher in the Oddis sphincter retention group and the differences were all statistically significant (P < 0.05). Conversely, there were no significant differences in bilirubin decline, liver function improvement, and stent patency between the two groups (P > 0.05).
Conclusion: Leaving the Oddis sphincter untouched during biliary stent placement can reduce the incidence of postoperative complications, while there was no effect on stent patency or jaundice relief. Therefore, it is recommended to preserve the Oddis sphincter when the stenosis is more than 3 cm above the duodenal papilla.

Keywords: Interventional radiology, malignant biliary obstruction, metallic stent, preserving the oddis sphincter


How to cite this article:
Liu C, Xing W, Si T, Guo Z, Yu H. Should the Oddis sphincter be retained? A clinical analysis of biliary metal stent implantation in patients with malignant obstructive jaundice. J Can Res Ther 2020;16:1119-24

How to cite this URL:
Liu C, Xing W, Si T, Guo Z, Yu H. Should the Oddis sphincter be retained? A clinical analysis of biliary metal stent implantation in patients with malignant obstructive jaundice. J Can Res Ther [serial online] 2020 [cited 2020 Oct 26];16:1119-24. Available from: https://www.cancerjournal.net/text.asp?2020/16/5/1119/296431




 > Introduction Top


Advanced stages of pancreatic, biliary, and metastatic cancer are the main causes of malignant obstructive jaundice. In patients with unresectable distal malignant biliary obstruction (MBO), self-expandable metal stents (SEMS) are an established palliative treatment option for the relief of obstructive jaundice if the predicted life expectancy is >1 month.[1],[2] A large number of clinical studies have shown that biliary stenting can effectively relieve the symptoms of obstructive jaundice, improve the quality of life of patients, and prolong the survival of patients. At present, however, research on biliary stent implantation for the treatment of malignant obstructive jaundice has mainly focused on choosing between plastic stents or metal stents,[3] the use of covered and uncovered self-expandable stents,[4],[5],[6],[7] causes of reobstruction following biliary stent placement,[8],[9],[10] and second interventions in the case of occluded metal stents. To our knowledge, there are no relevant research reports on whether distal malignant obstructive jaundice, which cannot be surgically removed, allows for the Oddis sphincter to remain untouched during biliary stent implantation. The functions of the  Sphincter of Oddi More Detailss include regulating bile flow, managing the flow of pancreatic juice, preventing mutual traffic between the bile and the pancreatic juice, and limiting reflux of the duodenal contents. This study sought to analyze the patency time, clinical outcomes, postoperative complications, and quality of life scores in patients with unresectable distal malignant obstructive jaundice who received stents that covered the Oddis sphincter or did not.


 > Materials and Methods Top


Patients

Approval for this study was obtained from the institutional ethics committee and written informed consent was obtained from each patient before their respective procedures. We retrospectively reviewed the medical records of patients who underwent metallic biliary stent therapy between January 2010 and January 2017 at our academic institutions and all clinical and laboratory data used in this study were collected by a review of these medical records. MBO was diagnosed based on laboratory, radiologic, and/or pathology evaluations. Radiologic studies included ultrasound, computed tomography (CT), and/or magnetic resonance imaging (MRI). A total of 133 patients with malignant hilar biliary obstruction were treated by percutaneous placement of metallic biliary stents. These patients were then divided into two groups according to whether the stent covered (Group A, n = 55) the Oddis sphincter or not (Group B, n = 78).

All patients were screened for eligibility to be included in this study based on the following inclusion criteria: (1) the presence of newly diagnosed malignant low-level biliary obstruction; (2) the biliary tract expansion and obstructive sites were confirmed by imaging, such as CT or MRI; (3) the level of serum bilirubin was increased and the direct bilirubin level was increased significantly; (4) the patient was not a suitable candidate for surgical operation; (5) the patient showed adequate cardiopulmonary, hepatic, and renal functions; (6) no infections were observed; and (7) the life expectancy was >4 months. Conversely, the exclusion criteria were the presence of a coagulation disorder or dysfunction, an international normalized ratio of 1.7 (or platelets <50 K), the presence of a serious infection, repeated biliary stent implantation, and past endoscopic retrograde pancreatic angiography.

The treatment protocol was as follows: all patients enrolled in this study were treated with metallic biliary stent implantation (BARD E-LUMINEXX biliary stent; Bard Peripheral Vascular, Inc., Tempe, AZ, USA). Depending on the size, location, and stenosis of the bile duct, the biliary stent over the distal of stricture by 1.5–2 cm. The biliary drainage tube was selected according to the patient's bilirubin level. Prophylactic antibiotic treatment was administered 30 min before interventional therapy.


 > Methods Top


Using CT or MRI, we evaluated the extent of tumor invasion and determined the most appropriate percutaneous access route in all patients. Under local anesthesia, the peripheral bile duct was punctured using a 22-gauge Chiba needle (Cook Medical, Bloomington, IN, USA) under fluoroscopy guidance and an 8.5-French (F) drainage catheter was inserted for biliary decompression and treatment of cholangitis. Biliary stent placement was performed five to 10 days following percutaneous transhepatic biliary drainage catheter insertion. For stent placement, a 5-F KMP catheter (Cook Medical, Bloomington, IN, USA) and a 0.035-in hydrophilic guidewire (Standard Glidewire; Terumo, Tokyo, Japan or Roadrunner UniGlide Hydrophilic Wire Guide; Cook Medical, Bloomington, IN, USA) were advanced past the hilar obstruction segment to the common bile duct or duodenum. The 8.5-F drainage catheter (Cook Medical) was placed at the distal tip of the biliary stent for 3–5 days after stent placement and removed when the patency of the biliary stent was confirmed by laboratory findings and imageological examination (i.e., favorable passage of contrast media through the biliary stent into the common bile ductor duodenum). In this study, not all of the percutaneous transhepatic biliary drainage procedures and biliary stenting procedures were performed during the same session in all cases.

Efficacy and safety assessments

Technical success was defined as the placement of the stent at least 1 cm from the tumor borders and with adequate contrast drainage. Clinical success referred to the achievement of a 25% or greater decrease in total bilirubin serum level by 7 days after stent placement. A complication referred to any adverse event directly related to stent placement or to its design (e.g., perforation, migration, obstruction, hemorrhage, pancreatitis, and cholecystitis). Stent obstruction was diagnosed if jaundice recurred or if laboratory parameters were compatible with biliary tract obstruction. Complications were considered to be “early” if they developed within 30 days and “late” if they developed 30 days after stent placement. These definitions were based on the 2014 Tokyo criteria for transpapillary biliary stenting.[11] The following variables were studied: age, gender, tumor origin, total bilirubin serum values, direct bilirubin, alkaline phosphatase, and gamma-glutamyl transferase count before and after stent placement. The Eastern Cooperative Oncology Group score was used to evaluate the quality of life of patients before and after treatment.

Statistical analyses

All statistical analyses were performed using the Statistical Package for Social Sciences (SPSS 19.0 for Windows; IBM Corp., Armonk, NY, USA) and Prism 7 (GraphPad Software, San Diego, CA, USA). A life table and Kaplan–Meier survival curves were used for estimating the time of stent patency. The cutoff value used for the analysis of the clinical impact of treatment was the mean of all the patients' data. Measurement data and numeration data were compared with a t-test and Chi-squared test, respectively. Variables with P < 0.05 were defined as being statistically significant.


 > Results Top


Patient characteristics

A total of 133 patients, including 47 females and 86 males with an age range of 37–75 years (mean age: 61.62 ± 5.97 years) were included in the current study. There were no significant differences in baseline clinical characteristics between the two groups [Table 1]. The main cause of biliary obstruction was pancreatic cancer in 81 patients (60.90%), while 16 patients (12.03%) had gallbladder cancer, 16 patients (12.03%) had liver carcinoma, and 20 patients (15.04%) showed distant metastasis (e.g., gastric carcinoma, rectal cancer, lung cancer, or liposarcoma). The clinical staging of patients was as follows: 23 cases (17.29%) were in the second stage, 73 cases (54.89%) were in the third stage, and 37 cases (27.82%) were in the fourth stage. The most common symptoms were obvious jaundice and pruritus.
Table 1: Baseline characteristics of patients (x̄±s)

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Technical success and clinical success

Stent placement was technically successful in all patients. The clinical success rates were not statistically significantly different between patients with Oddis sphincter retention and without stent coverage (97.43% vs. 98.18%; P > 0.05). Postoperative pruritus symptomatic remission rates were 96.29% in the Oddis sphincter retention group and 94.44% in the Oddis sphincter nonretention group (P > 0.05), respectively. The decreases in total bilirubin, direct bilirubin, glutamic-pyruvic transaminase, and glutamic-oxal acetic transaminase in the Oddis sphincter retention group were slightly greater than those in the Oddis sphincter nonretention group, but the differences between the two groups were not statistically significant (P > 0.05) [Table 2].
Table 2: Evaluation of the efficacy of biliary stent implantation (x̄±s)

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Stent patency

The cumulative duration of stent patency in the Oddis sphincter nonretention group was longer than that in the Oddis sphincter retention group (median ± standard deviation: 8.2 ± 0.294 vs. 7.3 ± 0.269; P = 0.548, log-rank test) [Figure 1]. During the follow-up, the occurrence of stent dysfunction did not differ significantly between the two groups (P = 0.97). In addition, the breakdown of causes of stent dysfunction, including overgrowth (P = 0.69), ingrowth (P = 0.83), sludge occlusion (P = 0.84), and unknown cause (P = 0.93), did not differ in frequency between the groups [Table 3].
Figure 1: The time of stent patency between the two groups. The cumulative duration of stent patency in the stents uncover oddis sphincter group was longer than that in the stents cover oddis sphincter group, but there was no significant difference in the time of stent patency between the two groups

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Table 3: Causes of stent occlusion

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Adverse events of biliary stent

The incidence of acute infection of the biliary tract system was 16.36% in the Oddis sphincter retention group relative to 6.41% in the Oddis sphincter nonretention group (P < 0.05). The incidence rates of asymptomatic elevated pancreatic enzyme level and acute pancreatitis in the Oddis sphincter retention group were significantly higher than those in the Oddis sphincter nonretention group (10.91% vs. 2.56%; P < 0.05 and 27.27% vs. 10.26%; P < 0.05). The rate of delayed complications including repeated biliary system infections and chronic pancreatitis was higher in the Oddis sphincter retention group than in the Oddis sphincter nonretention group (12.24% vs. 1.28%; P < 0.05 and 14.55% vs. 2.56%; P < 0.05). There was no difference in pain or the incidence rates of gallbladder–cardiac reflex, hemobilia, and liver failure between the two groups [Table 4].
Table 4: Complications of biliary stent implantation

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 > Discussion Top


In patients with unresectable distal MBO, SEMS placement is regarded as the standard treatment and helps to relieve obstruction of the distal biliary tract when the expected survival is >1 month, showing a larger luminal diameter and longer patency than those of plastic stents.[1],[2] This study sought to analyze the patency time, clinical outcomes, postoperative complications, and quality of life scores of SEMS with and without retention of the Oddis sphincter in patients with unresectable distal malignant obstructive jaundice.

All patients in our study were treated with a percutaneous transhepatic drainage approach and the rate of technical success was 100% in both groups, with no differences observed in a comparison with results in the literature. Previous studies reported success rates when using endoscopic interventional and percutaneous transhepatic drainage approaches were all close to 100% and under the conditions of endoscopic intervention failure, stents can be successfully implanted through the percutaneous transhepatic drainage approach.[12],[13] In our study, clinical success rates according to the protocol of covered and uncovered Oddis sphincter were 97.43% and 98.18%, respectively, and there were no statistically significant differences in decreases in biochemical parameters. Other research suggests that clinical success rates range from 80% to 95.8%. The results of our study are also similar to these results.[14],[15],[16] The reasons for poor clinical efficacy include the range of tumor invasion, which may lead to inadequate drainage, and the duration of biliary obstruction, which can cause irreversible hepatocyte damage.

Stents patency time has always been a focus of clinical concern. Previous studies have shown that the median time for stent patency is between 5 and 8 months and the time for stent patency shows no significant correlation with the use of covered or uncovered stents nor with stent type.[4],[17] Our findings show that the median time periods for stent patency in patients with Oddis sphincter retention and nonretention were 8.2 months and 7.3 months, respectively. Although stent patency in the Oddis sphincter nonretention group was slightly longer than that in the Oddis sphincter retention group, the difference between the two groups was not statistically significant. The main reason for the stent patency time being longer than in previous research was that we included patients with distal obstruction in this study. In the present study, the most common causes of stent occlusion were sludge clog and tumor ingrowth, which is consistent with previous findings.[15],[18],[19]

In the present study, the complications after stent implantation in the two groups were compared and we found that the incidence rates of complications such as acute pancreatitis, acute biliary infection, biliary reflex, asymptomatic pancreatin, chronic pancreatitis, gallbladder–cardiac reflex, and recurrent biliary infection in the Oddis sphincter retention group were significantly higher than those in the Oddis sphincter nonretention group. Reasons for these complications included issues with guiding, in that the catheter and stent pushed repeatedly through the Oddis sphincter, leading to local inflammatory edema, while increasing the risk of bacterial retrograde into the biliary system and pancreatic duct;[20] the stent oppressing the Oddis sphincter, which prompted pancreatic enzyme secretions; and stimulus by contrast agents, where, in some cases, contrast agents traveled retrogradely into the pancreatic duct. However, there were no significant differences in pain, biliary tract bleeding, liver failure, and stent displacement between the two groups. The occurrence of complications in this study was also inconsistent to findings of previous research because there was a certain difference between the types of complications we found in our study and those previously reported. Further, the literature largely did not distinguish whether or not the Oddis sphincter was retained when discussing complications.

The primary limitations of the present study are that it was a retrospective, nonrandomized investigation that involved a small number of patients. In addition, there were no criteria on which to base the selection of whether or not to preserve the Oddis sphincter or criteria on which to base the selection of SEMS type at the individual institutions involved. Therefore, multicenter, prospective, randomized controlled studies involving a greater number of patients should be conducted.


 > Conclusion Top


The results of this study show that sphincter of Oddis should be preserved in the treatment of distally malignant obstructive jaundice that is 3 cm or more away from the Oddis sphincter to significantly reduce the occurrence of short-and long-term complications and prolong the survival of patients as well as greatly improve their quality of life and create favorable conditions for further treatment. At the same time, this approach does not affect the patency of the stent.

Acknowledgments

All authors would like to thank the patients who participated in this study.

Financial support and sponsorship

This study was supported by Oncology Intervention Research Fund of China Health Promotion Foundation (XM2018011000601).

Conflicts of interest

There are no conflicts of interest.



 
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Moss AC, Morris E, Leyden J, MacMathuna P. Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction. Eur J Gastroenterol Hepatol 2007;19:1119-24.  Back to cited text no. 3
    
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Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004;53:729-34.  Back to cited text no. 14
    
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Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, et al. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc 2010;72:907-14.  Back to cited text no. 15
    
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Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström P, Lindhoff-Larsson A, et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: Results from a randomized, multicenter study. Gastrointest Endosc 2010;72:915-23.  Back to cited text no. 18
    
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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