Keywords
Endoscopic papillectomy
-
hemorrhage
-
hemostatic forceps
-
prevention
Introduction
An endoscopic papillectomy (EP) procedure is generally performed for treatment of
a papillary adenoma,[1] whereas post-EP hemorrhage (PEPH) is a clinically serious adverse event associated
with that procedure.[2] As a result, various methods of hemostasis, including clipping, hypertonic saline-epinephrine
local injection, and argon plasma coagulation, have been reported for treatment of
PEPH.[3] In addition to those, hemostatic forceps, a device used mainly for coagulation of
exposed vessel in cases of endoscopic mucosal dissection, have recently been utilized
to perform soft coagulation as a PEPH treatment.[4] We have used hemostatic forceps for treatment of both emergency cases of PEPH and
its prevention. However, few studies have assessed such prophylactic use, and thus,
we conducted this retrospective study to clarify its utility.
Materials and Methods
We reviewed consecutive patients who underwent EP from April 2009 to March 2016 at
our hospital. Second-look endoscopy was performed within 1 week in all cases of both
groups with or without bleeding or anemia. During the early period (April 2009–March
2012), PEPH was treated after it developed with conventional procedures, including
clipping, hypertonic saline-epinephrine local injection, argon plasma coagulation,
and soft coagulation with hemostatic forceps (conventional procedures group). On the
other hand, from April 2012 to March 2016, soft coagulation with a hemostatic forceps
device (FD411-QR, Olympus, Tokyo, Japan) was performed prophylactically immediately
after EP or on the following day (prophylactic procedure group). Soft coagulation
was done only when there is a “red spot.” Red spots were defined as red-colored parts
of ulcer bed tissue with a clear boundary and seemed to include vessels. Many of the
red spots were present at the periphery of the ulcer. Only red spots were indicated
for soft coagulation, while the whitish part of ulcer tissue was not treated with
soft coagulation. If the endoscope did not show any red spots, soft coagulation was
not added. The hemostatic forceps device was used in a closed position without grasping
or strongly pressing the mucosa to avoid excessive coagulation of the deeper layer.
The coagulation wave was set at 60 W (VIO 300D, ERBE, Tubingen, Germany), and the
energization time was approximately 2 s or less. Second-look endoscopy was done for
all patients of both groups within a week after EP. Either JF260V or TJF260V (Olympus,
Tokyo, Japan) was used in this study. The primary outcome of the present study was
the onset of PEPH, which was defined as a decrease in hemoglobin ≥2 g/dL after EP
regardless of the presence of hematemesis or melena, and we compared the two groups.
In addition, as a secondary endpoint, the success rate and the incidence of the adverse
event of soft coagulation using hemostatic forceps were examined retrospectively.
Results
In this retrospective study, nine patients were enrolled, four of whom were included
in the conventional procedures group and five in the prophylactic procedure group.
Backgrounds and outcomes are shown in [Table 1]. Age and gender were similar between the groups. The mean maximum diameter of the
resected specimen was 15 mm in the prophylactic procedure group, which was slightly
smaller as compared with the conventional procedures group (21 mm) though the difference
was not significant.
Table 1
Comparisons of patient backgrounds, postendoscopic papillectomy hemorrhage incidence,
and complications between conventional procedures and prophylactic procedure groups
|
|
Conventional procedures group (n=4)
|
Prophylactic procedure group (n=5)
|
p
|
|
*Mann.Whitney U.test, #Fisherfs exact test
|
|
Mean age (years)
|
69
|
67
|
0.80*
|
|
Male (%)
|
75
|
80
|
1.00#
|
|
Mean maximum diameter of resected specimen (mm)
|
21
|
15
|
0.39*
|
PEPH occurred in three of the four patients in the conventional procedures group,
while only one of the five patients in the prophylactic procedure group developed
that condition. All cases of PEPH were successfully treated by endoscopic hemostasis.
The incidence of PEPH was 20% in the prophylactic procedure group and 75% in the conventional
procedures group though the difference between them was not statistically significant
(P = 0.206, Fisher's exact test) [Table 2].
Table 2
Comparisons of postendoscopic papillectomy hemorrhage incidence between conventional
procedures and prophylactic procedure groups
|
|
Conventional procedures group (n=4)
|
Prophylactic procedure group (n=5)
|
P
|
|
#Fisher's exact test. PEPH=Postendoscopic papillectomy hemorrhage
|
|
Incidence of PEPH* (%)
|
75
|
20
|
0.21#
|
Three of the five patients in the prophylactic treatment group had at least one red
spot and received soft coagulation (e.g., representative case report: case 1). On
the other hand, two patients had no red spots on the day of EP. One of the two patients
received soft coagulation for slight bleeding on the next day. This case did not meet
the criteria of PEPH, since the value of hemoglobin was not decreased (representative
case report: case 2). The other case did not have any red spots on both the day of
EP and the next day, but after 5 days, hemoglobin was found to decrease by> 2 g/dl,
and he was the only patient who met the criteria of PEPH in the prophylactic treatment
group. Four cases of emergency bleeding after EP were experienced in this study, but
in all cases, hemostasis was obtained using soft coagulation using hemostatic forceps.
There was a case of abdominal pain after hemostasis, but it was relieved promptly
by conservative treatment.
Representative cases report
Case 1 (prophylactic group)
A 60-year-old woman underwent EP for an adenoma of the ampulla [Figure 1]a, and the pathological examination revealed curative resection. Although no hemorrhaging
was noted immediately after the procedure, second-look endoscopy performed the next
day showed a few reddish spots in the ulcer bed [Figure 1]b. At the time of the second-look endoscope, we coagulated to only the red points
by slightly touching those spots with the end of the clamped hemostatic forceps, which
resulted in them changing to have a whitish appearance [Figure 1]c. The patient was discharged according to schedule without any evidence of bleeding
or complications associated with the hemostasis technique.
Figure 1: (a) A 60-year-old woman underwent endoscopic papillectomy a b for an adenoma of
the ampulla. (b) Second-look endoscopy performed the next day showed a few reddish
spots in the ulcer bed (arrow). (c) Soft coagulation using hemostatic forceps was
performed for prevention of the late-onset bleeding and reddish spots became whitish
in appearance
Case 2 (prophylactic group)
In another representative case, a 59-year-old male taking oral warfarin for deep vein
thrombosis was diagnosed with an adenoma of the ampulla. Warfarin administration was
discontinued from 1 week before, heparin intravenous injection (10,000 units/day)
was started instead, and it was discontinued from 6 h before EP. Just before performing
EP, we confirmed that the international normalized ratio was 2 or less. In this case,
soft coagulation was not performed immediately after EP because red spots were not
revealed. Even before heparin was administered again, a second-look endoscopy examination
on the next day after EP showed asymptomatic bleeding from the ulcer [Figure 2]a, for which our hemostatic forceps technique was successfully used for soft coagulation
[Figure 2]b. The bleeding did not cause any symptoms and a decrease of hemoglobin value, and
therefore, we judged that this case did not fall under PEPH cases. The pathological
examination revealed adenoma with curative resection.
Figure 2: (a) A second-look endoscopy performed the next day after endoscopic papillectomy
revealed bleeding from the ulcer. (b) Hemostat forceps were used for soft coagulation,
which controlled postendoscopic papillectomy hemorrhage without complications
Discussion
Endoscopic treatment for a papillary adenoma was reported by Binmoeller et al. in
1993 as an endoscopic snare excision of benign adenomas of the papilla of Vater.[5] Thereafter, the procedure, termed EP or endoscopic ampullectomy, has been used throughout
the world, as it is less invasive than surgical resection and can be utilized as a
standard treatment for adenomas of the ampulla. However, according to a review by
De Palma et al., the overall rate of complications after EP varies from 8% to 35%,
with the most common being pancreatitis (5%–15%) and bleeding (2%–16%).[6] Tsuji et al. also noted that PEPH was observed in 21 (18.2%) of 115 patients though
endoscopic hemostasis was difficult to perform in only one of those cases.[7] Several endoscopic hemostasis techniques for treatment of PEPH have been proposed.
Mutignani et al. reported that a technique of injection of diluted fibrin glue might
be an effective endoscopic modality to treat refractory post-ERCP bleeding including
PEPH,[8] while Ito et al. presented an argon plasma coagulation technique for emergency hemostasis
in PEPH cases.[3] In addition, Klein et al. found that nonpulsatile focal intraprocedural bleeding
unresponsive to snare tip soft coagulation could be controlled with the use of coagulation
forceps in most cases.[4] In this study, we examined the results of soft coagulation using hemostatic forceps
for four patients who had emergency bleeding after EP and succeeded in all cases as
a result. Accordingly, endoscopic hemostasis for emergency PEPH seems to be an effective
treatment method. However, the usefulness of endoscopic treatment for prevention of
the condition remains unclear. In the present study, we investigated the utility of
an endoscopic prophylactic hemostatic procedure to prevent PEPH, with focus on the
use of soft coagulation with hemostatic forceps.
Procedures for obtaining soft coagulation with hemostatic forceps have developed with
the spread of endoscopic submucosal dissection, and a recent study noted its use for
gastroduodenal ulcer bleeding.[9] With soft coagulation, one of the modes available in electrosurgical workstations
produced by ERBE such as the VIO 300D, temperature is adjusted to just below the boiling
point and treated tissue shrinks with dehydration and carbonization, which seals the
lumen of the vessel to obtain hemostasis.[10] Nunoue et al. reported that soft coagulation with hemostatic forceps achieved primary
hemostasis for peptic ulcer bleeding in 96% of their cases, which was significantly
higher than the 67% of success rate in the heater probe thermocoagulation group (P
< 0.0001).[10] Kim et al. found that both efficacy and safety of soft coagulation using hemostatic
forceps were not inferior to those of argon plasma coagulation performed for peptic
ulcers bleeding. Furthermore, Arima et al. noted that the incidence of recurrent bleeding
after hemostasis was 2% in patients who received soft coagulation, which was lower
than that of the clipping group (10%).[11] The same as with other devices, soft coagulation using hemostatic forceps has a
high hemostatic capability and may also result in a decrease in recurrent bleeding
as compared with clipping. Furthermore, the hemostatic forceps device is easily handled
with the elevator of an ERCP scope as compared to a clipping device, which is more
difficult because of the complexity of operation. With these issues in mind, we focused
on soft coagulation using hemostatic forceps as a method to prevent bleeding after
EP and found this prophylactic procedure to be suitable as a routine technique from
the standpoint of the convenience of operation.
The difference in regard to PEPH incidence between the present groups was not significant,
likely because of the small sample size. For obtaining data to show a significant
difference, a sample size with an alpha-error of 0.05 and power of 0.8 would be required,
indicating that 15–20 cases would be needed in each group. On the other hand, the
mean maximum diameter of the resected specimen was 15 mm in the prophylactic procedure
group, smaller as compared with the conventional procedures group (21 mm). We were
unable to avoid selection bias, which also might have influenced the results. A future
prospective study for the accumulation of additional cases would be helpful.
Financial support and sponsorship
Nil.
