SEARCH

SEARCH BY CITATION

Keywords:

  • biliary stenting;
  • metallic stent;
  • plastic stent;
  • unresectable malignant hilar stricture

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References

Biliary stenting for unresectable malignant biliary strictures is widely accepted and is routinely done as an effective palliation therapy. However, a consensus among experts is still far from being reached on the selection of stents, placement procedures etc. In 2012, the European Society of Gastrointestinal Endoscopy reported guidelines for biliary stenting. At the Endoscopic Forum Japan 2012, a consensus meeting was held to examine seven statements that had been prepared based on these guidelines.Herein, we report the contents and the results of the examination of three of these statements on biliary stenting for hilar strictures.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References

Unresectable malignant biliary strictures are known to cause jaundice, hepatic dysfunction, and also acute cholangitis, which reduce quality of life (QOL) for affected patients.[1] Endoscopic biliary stenting for this condition has been widely accepted as an effective palliation treatment, and its efficacy has been demonstrated.[2-6] However, there is still considerable controversy regarding the types of stents to be used and also the placement procedures; no widespread consensus has yet been reached. In 2012, the European Society of Gastrointestinal Endoscopy (ESGE) published guidelines for biliary stenting entitled ‘Biliary stenting: Indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline’.[7] Although these guidelines included some recommendations based on sufficient evidence, there are many issues still requiring further examination. In August 2012, the Endoscopic Forum Japan (EFJ 2012) was held in Otaru, Hokkaido, Japan. In the pancreatobiliary session of this forum, we held a consensus meeting to examine seven statements on biliary stenting for unresectable malignant biliary strictures, which were prepared based on the ESGE guidelines. The results of this meeting on biliary stenting for unresectable hilar malignant biliary strictures are reported herein.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References

Statements

We prepared seven statements based on the ESGE guidelines. There were four statements regarding middle to lower biliary strictures (Statements ML1–ML4) and three statements regarding hilar strictures (Statements H1–H3). Each statement was sent to the discussants by email 1 month before the start of the EFJ 2012 session. Categorization of evidence and the voting schema were modified according to the Canadian Task Force on the Periodic Health Examination (Table 1). Choices of voting on statements were categorized as follows: a, accept completely; b, accept with some reservation; c, accept with major reservation; d, reject with reservation; and e, reject completely.

Table 1. Quality of evidence and voting on statements
Category and gradeDescription
  1. RCT, randomized controlled trial.

Quality of evidence 
1++High-quality meta-analyses, systematic reviews of RCT, or RCT with a very low risk of bias
1+Well-conducted meta-analyses, systematic reviews of RCT, or RCT with a low risk of bias
1−Meta-analyses, systematic reviews, or RCT with a high risk of bias
2++High-quality systematic reviews of case–control or cohort studies; high-quality case–control studies or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal
2+Well-conducted case–control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal
2−Case–control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal
3Non-analytical studies, e.g. case reports, case series
4Expert opinion
Voting on statement 
aAccept completely
bAccept with some reservation
cAccept with major reservation
dReject with reservation
eReject completely

In the consensus meeting, one of the statements was initially presented, and the first vote was taken by the discussants on whether they agreed with the statement. Then, the pre-assigned discussants presented their views on the issue, and a discussion was carried out afterwards. After the discussants had sufficiently discussed the issue to a reasonable extent, the final vote was taken. In the same manner, votes were taken on the other six statements in succession. Consensus was considered to be achieved when at least 80% of voting members gave a response of ‘accept completely’ or ‘accept with some reservation’. A statement was refused when at least 80% of voting members gave a response of ‘reject completely’ or ‘reject with some reservation’. If no consensus had been achieved after the final vote, we sent altered statements to all discussants by email after completion of the EFJ 2012 and asked them again whether they would agree with the altered statements (Table 2).

Table 2. Results of voting on statements for malignant hilar biliary stricture
 StatementFirst voteFinal voteConsensus
H1Plastic stents and uncovered self-expandable metallic stents (SEMS) yield similar short-term results in patients with malignant hilar stricture but SEMS provide a longer biliary patency compared with plastic stents (PS).

a: 61%

b: 31%

c: 8%

d: 0%

e: 0%

a: 69%

b: 23%

c: 8%

d: 0%

e: 0%

Agree
H2After bilateral biliary opacification upstream from malignant hilar stricture, morbidity and mortality rates are higher with unilateral compared with bilateral biliary drainage.

a: 23%

b: 38%

c: 31%

d: 8%

e: 0%

a: 23%

b: 46%

c: 31%

d: 0%

e: 0%

Disagree
H2-alteredAfter bilateral biliary opacification upstream from malignant hilar stricture in cases of Bismuth-Corlette types 2 and 3, morbidity and mortality rates are higher with unilateral compared with bilateral biliary drainage. 

a: 15%

b: 77%

c: 0%

d: 8%

e: 0%

Agree
H3Stent dysfunction in patients with malignant hilar stricture is treated as follows: plastic stents (PS) are removed, ducts are cleaned and new stents are inserted; uncovered self-expandable metallic stents (SEMS) are cleaned and, in the case of persistent stricture, new stents are inserted. The choice between PS or SEMS for re-stenting is based on the degree of biliary infection and the life expectancy.

a: 15%

b: 39%

c: 46%

d: 0%

e: 0%

a: 0%

b: 85%

c: 15%

d: 0%

e: 0%

Agree

Membership of the consensus group

Voting members of the consensus group were selected using the following criteria:

  1. Demonstration of knowledge and expertise in biliary stenting through publication/research or participation in national or regional guidelines development.
  2. Geographical representation of the Asia region including Japan.

Representative countries were Japan, China, India, Korea, and Thailand.

The members of this consensus meeting were the following 13 individuals: Hirotoshi Ishiwatari (Sapporo Medical University), Kei Ito (Sendai Open Hospital), Takao Itoi (Tokyo Medical University), Hiroyuki Isayama (The University of Tokyo), Naoki Okano (Toho University), Ichiro Yasuda (Gifu University), Hiroki Kawashima (Nagoya University), Hironari Kato (Okayama University), Yoshinobu Okabe (Kurume University), Dong Wang (Changhai Hospital), Jong Ho Moon (Soon Chun Hyang University Bucheon Hospital), Sundeep Lakhtakia (Asian Institute of Gastroenterology), and Rungusun Rerknimitr (Chulalongkorn University Hospital).

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References

Statement H1

Plastic stents (PS) and uncovered self-expandable metallic stents (SEMS) yield similar short-term results in patients with malignant hilar stricture but SEMS provide a longer biliary patency compared with PS. (Evidence level 1–)

Level of agreement

First vote: a, 61%; b, 31%; c, 8%; d, 0%; e, 0%

Final vote: a, 69%; b, 23%; c, 8%; d, 0%; e, 0%

For this statement, 92% consensus was achieved at the first vote, and there were many voting members recommending SEMS rather than PS for malignant hilar obstruction.[8-10] However, 31% of members accepted this statement with some reservations. The main reason for the reservations was that, although SEMS have a longer patency period than PS, many endoscopists often select PS in Japan because a second intervention is difficult to carry out with SEMS.[11, 12] There was an opinion that this situation should be added to the statement. Moreover, some members also indicated that further innovation and ongoing research efforts are needed to prolong the patency period of PS.

One voting member did not agree with the statement. This member considered that placement of a PS inside the bile duct without sphincterotomy to be better. Early occlusion of PS has been mainly attributable to retrograde infection. Based on examination of cases undergoing resection, although conventional PS placement frequently causes retrograde cholangitis, its incidence can be kept low by PS placement inside the bile duct. Thus, there was an opinion that PS placement inside the bile duct facilitates a second intervention and can be expected to prolong the patency period. In fact, still unpublished data show that the patency period of an internal stent is approximately 150 days, and that longer patency is achieved in comparison with the results of previous reports. In contrast, some participants indicated that, although PS placement inside the bile duct is effective in benign cases, such as those with stricture after hepatic transplantation, it is better in cases with malignancies to initially place a metallic stent and then a PS. At present, this opinion is not supported by clear evidence, and we considered that it should be further examined in the future.

The result of the final vote was almost the same as that of the first vote, and a consensus was thus achieved.

Statement H2

After bilateral biliary opacification upstream from malignant hilar stricture, morbidity and mortality rates are higher with unilateral than with bilateral biliary drainage. (Evidence level 2–)

Level of agreement

First vote: a, 23%; b, 38%; c, 31%; d, 8%; e, 0%

Final vote: a, 23%; b, 46%; c, 31%; d, 0%; e, 0%

Sufficient evidence is as yet lacking as to whether unilateral or bilateral biliary drainage should be carried out.[13-16] A common reason for this statement being unacceptable was that it did not mention the morphology of biliary strictures. In other words, unilateral biliary drainage may be sufficient in Bismuth-Corlette type 1, whereas bilateral biliary drainage is required in types 2, 3, and 4.

Furthermore, the following opinion regarding contrast imaging of biliary branches, in cases of stenting for hilar strictures, was also presented. In order to avoid injection of unnecessary contrast medium, instead of imaging the bile duct from the lower part, a guidewire should first be advanced to a targeted biliary branch, and contrast medium should then be injected.[17-19] Moreover, in patients with advanced hilar obstruction (Bismuth-Corlette type 4), the morbidity and mortality of successful bilateral stenting are better than those in patients who have bilateral opacification but in whom only unilateral stenting is achieved. This point was recognized as being extremely important for stenting of hilar strictures. Based on the discussion, the statement was changed so as to be adjusted according to the Bismuth-Corlette classification, as shown below.

Altered statement H2

After bilateral biliary opacification upstream from malignant hilar stricture in cases of Bismuth-Corlette types 2 and 3, morbidity and mortality rates are higher with unilateral than with bilateral biliary drainage.

Level of agreement for altered statement

a, 15%; b, 77%; c, 0%; d, 8%; e, 0%

A consensus was achieved on the statement adjusted to the Bismuth-Corlette classification. If the bile duct upstream from the biliary stricture is opacified in cases of type 2 or above, bilateral biliary drainage should be considered.

Statement H3

Stent dysfunction in patients with malignant hilar stricture is treated as follows: plastic stents (PS) are removed, ducts are cleaned and new stents are inserted; uncovered self-expandable metallic stents (SEMS) are cleaned and, in the case of persistent stricture, new stents are inserted. The choice between PS or SEMS for re-stenting is based on the degree of biliary infection and the life expectancy. (Evidence level 2–)

Level of agreement

First vote: a, 15%; b, 39%; c, 46%; d, 0%; e, 0%

Final vote: a, 0%; b, 85%; c, 15%; d, 0%; e, 0%

Reintervention for malignant hilar strictures is difficult in some cases.[20] The major reasons for reservations regarding this statement are that cleaning of uncovered SEMS is generally done with unilateral biliary drainage, and that the inside of the first stent cannot be cleaned in many cases undergoing bilateral biliary drainage. Method of cleaning SEMS is by using a balloon trawl, like those used for sludge, but this may be challenging if the balloon cannot be passed proximal to the stricture or proximal to the margin of the stent. Also, in this situation, the inflated balloon may rupture if it is impinging on the sharp struts of the SEMS. Another way to clean SEMS is by injecting saline through the stent to flush it, but this may actually result in introducing infection into an undrained segment.

Another reason for not agreeing with the statement was that, in many cases, endoscopic reintervention is difficult in hilar strictures and conversion to a percutaneous approach is ultimately necessary. In contrast, the following opinions were presented: endoscopic reintervention should be carried out to the possible extent because patient QOL is reduced when a percutaneous approach is used; a PS can be placed as the second stent in almost all cases with unilateral stenting; and a PS can also be placed in cases with bilateral stenting. Based on the discussion, this statement was eventually supported, although issues such as difficulty carrying out procedures and the effects of drainage remain when dealing with reintervention for patients with a stent placed in the hepatic hilum.

Conclusion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References

A consensus meeting was held regarding unresectable malignant biliary strictures. In this meeting, discussions were held on the selection of stents, selection of bilateral or unilateral drainage after injection of contrast medium in patients with hilar stricture, and reintervention for stent occlusion. A degree of consensus was achieved. However, because there are many further issues awaiting future resolution, further studies appear to be necessary.

Conflict of Interests

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References

Authors declare no conflict of interests for this article.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Conclusion
  7. Conflict of Interests
  8. References
  • 1
    Van Laethem JL, De Broux S, Eisendrath P, Cremer M, Le Moine O, Devière J. Clinical impact of biliary drainage and jaundice resolution in patients with obstructive metastases at the hilum. Am. J. Gastroenterol. 2003; 98: 12711277.
  • 2
    Taylor MC, McLeod RS, Langer B. Biliary stenting versus bypass surgery for the palliation of malignant distal bile duct obstruction: A meta-analysis. Liver Transpl. 2000; 6: 302308.
  • 3
    Cvetkovski B, Gerdes H, Kurtz RC. Outpatient therapeutic ERCP with endobiliary stent placement for malignant common bile duct obstruction. Gastrointest. Endosc. 1999; 50: 6366.
  • 4
    Levy MJ, Baron TH, Gostout CJ, Petersen BT, Farnell MB. Palliation of malignant extrahepatic biliary obstruction with plastic versus expandable metal stents: An evidence-based approach. Clin. Gastroenterol. Hepatol. 2004; 2: 273285.
  • 5
    Arguedas MR, Heudebert GH, Stinnett AA, Wilcox CM. Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: A cost-effectiveness analysis. Am. J. Gastroenterol. 2002; 97: 898904.
    Direct Link:
  • 6
    Bueno JT, Gerdes H, Kurtz RC. Endoscopic management of occluded biliary wall stents: A cancer center experience. Gastrointest. Endosc. 2003; 58: 879884.
  • 7
    Dumonceau J-M, Tringali A, Blero D et al. Biliary stenting: Indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy 2012; 44: 277298.
  • 8
    Lee SH, Park JK, Yoon WJ et al. Optimal biliary drainage for inoperable Klatskin's tumor based on Bismuth type. World J. Gastroenterol. 2007; 13: 39483955.
  • 9
    Saluja SS, Gulati M, Garg PK et al. Endoscopic or percutaneous biliary drainage for gallbladder cancer: A randomized trial and quality of life assessment. Clin. Gastroenterol. Hepatol. 2008; 6: 944950.
  • 10
    Paik WH, Park YS, Hwang J-H et al. Palliative treatment with self-expandable metallic stents in patients with advanced type III or IV hilar cholangiocarcinoma: A percutaneous versus endoscopic approach. Gastrointest. Endosc. 2009; 69: 5562.
  • 11
    Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy 1993; 25: 213218.
  • 12
    Perdue DG, Freeman ML, Disario JA et al. Plastic versus self-expanding metallic stents for malignant hilar biliary obstruction: A prospective multicenter observational cohort study. J. Clin. Gastroenterol. 2008; 42: 10401046.
  • 13
    Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest. Endosc. 1998; 47: 354362.
  • 14
    Deviere J, Baize M, de Toeuf J, Cremer M. Long-term follow-up of patients with hilar malignant stricture treated by endoscopic internal biliary drainage. Gastrointest. Endosc. 1988; 34: 95101.
  • 15
    Inal M, Akgül E, Aksungur E, Seydaoğlu G. Percutaneous placement of biliary metallic stents in patients with malignant hilar obstruction: Unilobar versus bilobar drainage. J. Vasc. Interv. Radiol. 2003; 14: 14091416.
  • 16
    Naitoh I, Ohara H, Nakazawa T et al. Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction. J. Gastroenterol. Hepatol. 2009; 24: 552557.
  • 17
    Hintze RE, Abou-Rebyeh H, Adler A, Veltzke-Schlieker W, Felix R, Wiedenmann B. Magnetic resonance cholangiopancreatography-guided unilateral endoscopic stent placement for Klatskin tumors. Gastrointest. Endosc. 2001; 53: 4046.
  • 18
    Freeman ML, Overby C. Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents. Gastrointest. Endosc. 2003; 58: 4149.
  • 19
    Singh V, Singh G, Verma GR, Singh K, Gulati M. Contrast-free unilateral endoscopic palliation in malignant hilar biliary obstruction: New method. J. Gastroenterol. Hepatol. 2004; 19: 589592.
  • 20
    Dumonceau JM, Devière J. Self-expandable metal stents. Baillieres Best Pract. Res. Clin. Gastroenterol. 1999; 13: 109130.