Post-ERCP Bleeding After Biliary Stent Placement: Evidence-Based Diagnostic and Therapeutic Approach
CHẢY MÁU SAU CAN THIỆP ERCP
ĐẶT STENT
|
Case 26/07/2025: Bệnh nhân nam, 86 tuổi,
nhập viện vì tiêu phân đen xuất hiện sau 4 ngày can thiệp ERCP đặt stent đường
mật điều trị viêm đường mật cấp do sỏi ống mật chủ. Hiện tại, bệnh nhân tỉnh,
sinh hiệu ổn, bụng mềm, không đề kháng, thăm trực tràng có phân đen sệt. Xét
nghiệm: Hemoglobin 117 g/L. Nội soi dạ dày-tá tràng thấy máu đỏ tươi tại tá
tràng đoạn D1-D2, vùng nhú Vater có stent đường mật và máu đỏ tươi loang ra từ
trong nhú. Chụp CTA bụng ghi nhận dấu thoát thuốc cản quang tại thành trong
tá tràng đoạn D2. Bệnh nhân được chỉ định can thiệp tắc động mạch vị-tá tràng
qua DSA; sau can thiệp, chưa ghi nhận thêm tình trạng chảy máu. 1. Ở một bệnh nhân
không có tiền sử rối loạn đông máu, sau ERCP xuất hiện tiêu phân đen, vì sao
vẫn cần chỉ định các xét nghiệm PT, INR và tiểu cầu trong giai đoạn đánh giá
ban đầu? 2. Khi nội soi ống
tiêu hoá trên ghi nhận máu đỏ tươi tại tá tràng nhưng không xác định rõ vị
trí xuất huyết, trong bối cảnh bệnh nhân có stent đường mật, yếu tố nào giúp
quyết định ưu tiên chụp CTA trước khi nội soi lại? 3. Trong trường hợp
stent nhựa đường mật che khuất vùng nhú Vater và làm hạn chế tầm nhìn, phương
pháp cầm máu nào nên được lựa chọn đầu tiên để vừa hiệu quả vừa an toàn, và tại
sao? 4. Khi đã tiêm
epinephrine quanh vùng nhú nhưng không đạt được cầm máu hoàn toàn, trong bối
cảnh kỹ thuật đặt clip bị cản trở bởi stent, nên lựa chọn phương án can thiệp
tiếp theo nào để kiểm soát chảy máu? 5. Nếu CTA ghi nhận
thoát thuốc tại thành tá tràng nhưng bệnh nhân hiện tại ổn định huyết động,
có nên trì hoãn DSA để thực hiện nội soi lại hay không? Giải thích lựa chọn. 6. Trong trường hợp cần
đặt FCSEMS để kiểm soát chảy máu nhú Vater ở bệnh nhân đang có sẵn stent nhựa,
cần cân nhắc yếu tố nào trước khi rút bỏ stent cũ và triển khai stent mới? 7. Sau khi bệnh nhân
được can thiệp tắc mạch thành công bằng DSA, cần theo dõi những chỉ số lâm
sàng và xét nghiệm nào trong 24–48 giờ đầu để đánh giá hiệu quả kiểm soát chảy
máu và phát hiện biến chứng sớm? |
1. Stepwise Diagnostic Approach
Initial
Clinical Assessment and Stabilization
The first step in the
diagnostic algorithm is immediate clinical assessment to determine the severity
of bleeding and the patient’s hemodynamic status. Acute post-ERCP bleeding
may present as visible blood during the procedure or as hematemesis, melena, or
hematochezia shortly after. Vital signs should be monitored continuously,
and intravenous access established for fluid resuscitation. Laboratory
studies must include a complete blood count (CBC) to assess hemoglobin and
hematocrit, as well as a basic metabolic panel. Although the patient is
known to be without coagulopathy, it remains standard to check prothrombin time
(PT), international normalized ratio (INR), and platelet count to confirm the
absence of unrecognized bleeding diatheses. The American
Gastroenterological Association (AGA) notes that there is no specific PT/INR or
platelet threshold that predicts post-ERCP bleeding risk, but these tests are
part of the routine workup to exclude unexpected abnormalities.[1-2]
Endoscopic
Evaluation
If bleeding is
identified during ERCP, the endoscopist should attempt to localize the source
immediately. The most common sources are the sphincterotomy site, the
papilla, or, less commonly, the CBD itself, especially in the context of stent
placement. The ASGE recommends that endoscopic visualization is the
primary diagnostic and therapeutic modality for acute post-ERCP bleeding.[1] If
delayed bleeding is suspected after the patient is transferred to recovery,
urgent repeat endoscopy is indicated if there is ongoing or significant
clinical evidence of bleeding, such as hemodynamic instability, ongoing
hematemesis, or a significant drop in hemoglobin.[1][3-4]
Imaging
Modalities
If endoscopic
evaluation fails to localize the bleeding source, or if bleeding is suspected
to originate from a site not accessible by endoscopy (such as higher up in the
biliary tree or from a vascular injury), cross-sectional imaging is warranted. Contrast-enhanced
computed tomography (CT) or CT angiography can identify active extravasation,
pseudoaneurysm, or hemobilia, particularly in cases of severe or refractory
bleeding.[5-6] If imaging
suggests a vascular source or if endoscopic therapy is unsuccessful, digital
subtraction angiography (DSA) is indicated both for diagnostic localization and
for potential therapeutic intervention (transcatheter arterial embolization,
TAE).[1][7] DSA is
particularly valuable in cases of hemobilia or when bleeding is suspected to
arise from the hepatic or pancreaticoduodenal arteries, which may be injured
during ERCP or stent placement.[5][7]
Stepwise
Diagnostic Algorithm Table
The following table
summarizes the stepwise diagnostic approach, including the relevant
quantitative and procedural details.
The table below
outlines the recommended stepwise diagnostic approach for acute post-ERCP
bleeding with plastic CBD stent placement, including key actions and supporting
references.
|
Step |
Description |
|
1. Initial clinical assessment and
stabilization |
Assess
hemodynamics, resuscitate, obtain CBC, PT/INR, platelets |
|
2. Endoscopic evaluation |
Localize
and characterize bleeding source during or after ERCP; urgent repeat
endoscopy if needed |
|
3. Imaging studies |
Contrast-enhanced
CT/CT angiography if endoscopy inconclusive or severe bleeding |
|
4. Angiographic evaluation (DSA) |
Diagnostic
and therapeutic angiography for vascular source or refractory bleeding |
2. Evidence-Based Stepwise
Management Protocols
Initial
Stabilization and Resuscitation
Management begins with
rapid clinical assessment and hemodynamic stabilization. Intravenous
fluids should be administered as needed, and blood transfusion considered for
hemodynamically unstable patients or those with significant anemia, following a
restrictive transfusion strategy unless there is underlying cardiovascular
disease.[9] The ASGE
emphasizes that reversal of coagulopathy is not required in this scenario, as
the patient does not have a coagulopathy.[1]
Endoscopic
Hemostatic Therapy
Urgent endoscopic
evaluation is indicated to localize the bleeding source and initiate hemostatic
therapy. The most commonly used initial endoscopic therapy is the
injection of dilute epinephrine (typically 1:10,000 concentration) into and
around the bleeding site, with volumes generally between 0.5 mL and 4 mL per
injection, repeated as needed to achieve hemostasis.[1][10] If
epinephrine injection alone does not achieve hemostasis, additional endoscopic
modalities should be employed, including thermal therapies such as multipolar
electrocautery or argon plasma coagulation, and mechanical therapies such as
through-the-scope clips. The use of a forward-viewing endoscope with a cap
may facilitate clip placement in select cases, though this is technically
challenging in the presence of a plastic stent.[1]
Recent studies have
also explored the use of novel hemostatic agents, such as hemostatic powders
(e.g., TC-325, polysaccharide powders), which have shown promise in achieving
initial hemostasis and reducing rebleeding rates in post-ERCP bleeding, although
high-quality evidence is still emerging.[11-12] In
a randomized controlled trial, polysaccharide hemostatic powder achieved 100%
immediate hemostasis in nonpulsatile post-sphincterotomy bleeding, compared to
92.3% for endoscopic clips, with a shorter mean hemostasis time (50.8 vs 62.8
seconds, P = 0.011) and no delayed bleeding events in the powder group.[12]
Escalation
to Advanced Endoscopic or Radiologic Interventions
If standard endoscopic
therapies fail to control bleeding, escalation to advanced interventions is
warranted. The ASGE recommends the use of fully covered self-expandable
metal stents (FCSEMSs) for refractory postsphincterotomy bleeding, with a pooled
clinical success rate of 95% (95% CI, 89-98), a recurrent bleeding rate of 7%
(95% CI, 4-12), and an adverse event rate of 6% (95% CI, 2-16).[13-15] FCSEMSs
provide effective tamponade of the bleeding site and are particularly useful
when bleeding originates from within the ampulla or the mid/distal
CBD. However, their use is generally reserved for cases refractory to
standard endoscopic therapies due to higher cost and the need for subsequent
removal.[1][13]
When endoscopic
measures are unsuccessful or not feasible, angiographic embolization via DSA is
the next step. Angiographic interventions have been shown to control
bleeding in 83% to 100% of cases and are preferred over surgery due to lower
morbidity.[1][7][16] Surgery
is reserved as a last resort for cases where both endoscopic and angiographic
interventions have failed.[1][7][17-18]
Comparative
Efficacy, Risks, and Indications Table
The following table
provides a quantitative comparison of the efficacy, risks, and indications for
endoscopic, DSA, and surgical interventions in acute post-ERCP bleeding with
plastic CBD stents.
|
Modality |
Efficacy (Clinical Success) |
Risks/Complications |
Indications |
Special Considerations (Plastic Stent) |
|
Endoscopic (injection, thermal,
mechanical) |
90–97%
(first-line) |
Perforation,
pancreatitis, rare MI (epinephrine), technical difficulty (clips) |
First-line
for all significant post-ERCP bleeding |
Plastic
stent does not preclude use; not hemostatic itself |
|
FCSEMS (rescue) |
95%
(refractory cases) |
Stent
migration (10%), pancreatitis (7%), need for removal |
Refractory
to standard endoscopic therapy |
Plastic
stent usually removed before FCSEMS |
|
DSA/TAE |
83–100%
(refractory cases) |
Non-target
embolization, ischemia, contrast nephropathy |
Failure
of endoscopic therapy, inaccessible bleeding site |
No
specific contraindication |
|
Surgery |
High
(last resort) |
High
morbidity, infection, prolonged recovery |
Failure
of endoscopic and angiographic therapy |
No
specific contraindication |
3. Technical Considerations and
Limitations in the Context of Plastic Stents
The presence of a
plastic stent in the CBD introduces several technical considerations for
endoscopic hemostasis. Visualization and access to the bleeding site may
be impaired by the stent, limiting the efficacy of mechanical and thermal
therapies. Injection therapy with dilute epinephrine remains feasible but
may be less effective if the stent obstructs the bleeding site.[1] Clip
placement is technically challenging and often not possible with a stent in
situ, while thermal therapies must be used with caution to avoid stent damage
and collateral injury.[1] Balloon
tamponade may be less effective if the stent prevents adequate
compression. In some cases, removal or exchange of the plastic stent may
be necessary to allow for effective endoscopic hemostasis, but this carries its
own risks, including the potential for exacerbating bleeding or precipitating
cholangitis if biliary drainage is compromised.[1][19-20]
For refractory
bleeding, FCSEMS placement is an effective salvage therapy, but the plastic
stent is typically removed prior to FCSEMS deployment.[1][13-15] Rarely,
the stent itself may be the source of bleeding due to erosion or vascular
injury, particularly with prolonged placement.[5][20]
4. Outcomes, Prognosis, and
Prevention
Short-
and Long-Term Outcomes
Endoscopic therapy
achieves high rates of immediate hemostasis, with clinical success rates of
90–100% and low risk of rebleeding or major complications.[1][10][15] DSA/TAE
is highly effective for refractory cases, with technical and clinical success
rates of 83–100% and low rates of recurrence.[1][7] Surgery
is rarely required and is associated with higher morbidity, but remains
effective when indicated.[1][7][17-18] The
overall mortality from clinically significant post-ERCP bleeding is low, with a
2.3% fatality rate reported in a recent prospective study.[3] Most
deaths are attributable to underlying comorbidities or delayed recognition of
bleeding, rather than failure of hemostatic therapy.
This table provides a
quantitative summary of short- and long-term outcomes for each intervention
modality in acute post-ERCP bleeding with plastic CBD stents.
|
Intervention |
Short-Term Success Rate |
Rebleeding Risk |
Major Complications |
Long-Term Prognosis |
|
Endoscopic therapy |
90–100% |
Low |
Rare
(pancreatitis, MI) |
Excellent;
low late risk |
|
DSA/TAE |
83–100% |
Low |
Rare
(ischemia, nephropathy) |
Excellent;
rare late hemobilia |
|
Surgery |
High
(last resort) |
Very
low |
Higher
(infection, recovery) |
Good
if perioperative survival |
Prevention
Strategies
Prevention of post-ERCP
bleeding in patients receiving plastic CBD stents, particularly in those
without coagulopathy, is best achieved by careful patient selection, minimizing
unnecessary sphincterotomy, optimizing procedural technique, and appropriate management
of antithrombotic agents. The ASGE recommends avoiding unnecessary
sphincterotomy, using blended current for sphincterotomy, and minimizing
cannulation trauma.[1] Plastic
stents should not be relied upon for bleeding prevention and should be removed
within four weeks to minimize the risk of stent-related complications.[1][21] The
use of endoscopic papillary large balloon dilation (EPLBD) may be considered in
select high-risk patients, and prophylactic hypertonic saline-epinephrine
injection may be beneficial in certain contexts, though it is not standard for
all.[1]
Post-Hemostasis
Monitoring and Follow-Up
After successful
hemostasis, patients should be admitted for close observation, with frequent
assessment of vital signs and serial measurement of hemoglobin and hematocrit
every 6–12 hours for the first 24–48 hours, or until stable.[1][3] High-dose
intravenous proton pump inhibitor (PPI) therapy is recommended, with an 80 mg
intravenous bolus followed by an 8 mg/hour continuous infusion for 72 hours, or
an equivalent intermittent dosing schedule.[22-23] Vigilance
for complications such as cholangitis, pancreatitis, and stent occlusion or
migration is essential.[18] Plastic
CBD stents require planned follow-up for removal or exchange, typically within
4–12 weeks depending on the indication and patient-specific factors.[18][21] Outpatient
follow-up should be arranged within 1–2 weeks to reassess clinical status and
plan for elective stent management.[18]
5. Rare and Atypical Complications
Rare complications
associated with plastic CBD stents after ERCP include vascular injury,
hemobilia, and pseudoaneurysm formation. These complications are most
often related to mechanical trauma or pressure necrosis exerted by the stent on
adjacent vascular structures, particularly with long-term indwelling stents.[5][24-26] Hemobilia
may present as recurrent or delayed gastrointestinal bleeding, sometimes
accompanied by signs of biliary obstruction or cholangitis.[5][24-26] Recognition
requires a high index of suspicion, and diagnosis is often established with
contrast-enhanced CT or selective angiography.[5][24-26] Transarterial
embolization is the first-line therapy for pseudoaneurysm or arterial injury,
with high success rates and low risk of major complications.[5][24-26] Stent
removal or exchange may be necessary in cases of ongoing trauma or erosion.[20]
6. Patient-Specific Factors
Modifying Risk and Outcomes
Patient-specific
factors such as advanced liver disease, active cholangitis, coronary heart
disease, use of antithrombotic agents, anatomical variations, and procedural
complexity significantly modify the risk, management, and outcomes of acute
post-ERCP bleeding in the setting of plastic CBD stents.[3][8][27-29] The
presence of a plastic stent does not independently increase the risk of
post-ERCP bleeding, but may interact with patient-specific factors to influence
outcomes.[1][10] In rare cases,
long-term indwelling plastic stents can cause delayed bleeding due to pressure
necrosis or vascular erosion, particularly in patients with underlying vascular
fragility or chronic inflammation.[5][20]
7. Role of Novel and Adjunctive
Hemostatic Agents
Novel hemostatic
agents, such as hemostatic powders (e.g., TC-325, polysaccharide powders) and
peptide gels (e.g., PuraStat), have an emerging role in the management of acute
post-ERCP bleeding in patients with plastic CBD stents. These agents offer
practical advantages in difficult-to-access bleeding sites and may improve
immediate hemostasis rates, especially when conventional methods are
challenging or have failed.[11-12][30] In
a randomized controlled trial, polysaccharide hemostatic powder achieved 100%
immediate hemostasis in nonpulsatile post-sphincterotomy bleeding, compared to
92.3% for endoscopic clips, with a shorter mean hemostasis time and no delayed
bleeding events in the powder group.[12] However,
hemostatic powders are generally considered adjunctive or rescue therapies
rather than first-line definitive treatments, as their effect is often
temporary and requires subsequent definitive hemostasis by injection, thermal
coagulation, or mechanical clipping when feasible.[31]
The following table
summarizes the role, advantages, and limitations of novel hemostatic agents in
acute post-ERCP bleeding with plastic CBD stents.
|
Hemostatic Agent Type |
Role in Post-ERCP Bleeding with Plastic
CBD Stents |
Advantages |
Limitations |
|
Hemostatic powders (e.g., TC-325,
polysaccharide powders) |
Adjunctive/rescue
therapy for immediate hemostasis, especially in difficult-to-access sites |
Noncontact
application; covers large/diffuse bleeding areas; rapid deployment |
Temporary
effect; sloughs off within 24h; less effective in spurting arterial bleeding;
requires follow-up definitive therapy |
|
Novel peptide gels (e.g., PuraStat) |
Rescue
therapy after failure of conventional methods; effective in refractory
bleeding |
Safe;
effective; does not hinder further endotherapy |
Limited
data specific to ERCP; adjunctive use |
|
Injection therapy (dilute epinephrine) |
First-line
endoscopic therapy; often combined with powders |
Effective;
easy to perform |
Risk
of systemic effects; may be insufficient alone |
|
Thermal and mechanical therapies |
Definitive
hemostasis following initial control |
Durable
hemostasis |
Technical
challenges with stent; risk of injury |
8. Conclusion and Clinical
Recommendations
In summary, the
management of acute post-ERCP bleeding in patients with plastic CBD stents and
no coagulopathy should proceed in a stepwise fashion, beginning with immediate
clinical assessment and stabilization, followed by urgent endoscopic evaluation
and first-line hemostatic therapy with dilute epinephrine injection (0.5–4 mL
of 1:10,000 solution), escalation to thermal or mechanical therapies if needed,
and consideration of novel hemostatic agents or FCSEMSs for refractory
cases. If endoscopic measures fail, angiographic embolization via DSA is
highly effective, with technical and clinical success rates of
83–100%. Surgery is reserved for cases refractory to both endoscopic and
angiographic interventions. The presence of a plastic stent does not alter
this algorithm but may necessitate removal if FCSEMS placement is
required. Prevention strategies focus on minimizing unnecessary
sphincterotomy, optimizing procedural technique, and appropriate management of
antithrombotic agents. Post-hemostasis monitoring includes close inpatient
observation, high-dose intravenous PPI therapy (80 mg bolus, 8 mg/hour infusion
for 72 hours), and timely planning for elective stent management. Rare
complications such as vascular injury, hemobilia, and pseudoaneurysm require a
high index of suspicion and are best managed with transarterial
embolization. Patient-specific factors such as advanced liver disease,
active cholangitis, and procedural complexity significantly modify risk and
outcomes, necessitating individualized management strategies. These
recommendations are supported by the American Society for Gastrointestinal
Endoscopy, the American College of Gastroenterology, and the American College
of Radiology, as well as recent clinical studies and meta-analyses.[1][3][7][13]
