Endoscopic ultrasound for the evaluation of Nissen fundoplication integrity:a blinded comparison with conventional testing
E.Y.Chang,1R.C.Minjarez,1C.Y.Kim,1A.K.Seltman,1D.V.Gopal,2B.Diggs,1R.Davila,3J.G.Hunter,1B.A.Jobe 1,4
1Department of Surgery,Oregon Health &Science University,Portland,OR,USA 2Division of Gastroenterology,University of Wisconsin,Madison,WI,USA
3Division of Gastroenterology,Oregon Health &Science University,Portland,OR,USA
4
Portland VA Medical Center,Surgical Service—P3GS,P.O.Box 1034,Portland,OR,97207,USA
Received:3November 2006/Accepted:20November 2006/Online publication:8March 2007
Abstract
Background:For patients whose symptoms develop after Nissen fundoplication,the precise mechanis
m of anatomic failure can be difficult to determine.The au-thors have previously reported the endosonographic hallmarks defining an intact Nissen fundoplication in swine and the known causes of failure.The current clinical trial tested the hypothesis that a defined set of endosonographic criteria can be applied to determine fundoplication integrity in humans.
Methods:The study enrolled seven symptomatic and nine asymptomatic subjects at a mean of 6years (range,1–30years)after Nissen fundoplication.A validated gastroesophageal reflux disease (GERD)-specific ques-tionnaire and medication history were completed.Be-fore endoscopic ultrasound (EUS),all the patients underwent complete conventional testing (upper endoscopy,esophagram,manometry,24-h pH).A diagnosis was rendered on the basis of combined test results.Then EUS was performed by an observer blin-ded to symptoms,medication use,and conventional testing diagnoses.Because EUS and esophagogastro-duodenoscopy (EGD)are uniformly performed in combination,the EUS diagnosis was rendered on the basis of previously established criteria combined with the EGD interpretation.The diagnoses then were com-pared to examine the contribution of EUS in this setting.
Results:The technique and defined criteria were easily applied to all subjects.All symptomatic patients had heartburn and were taking proton pump inhibitors (PPI).No asymptomatic patients were
taking PPI.All
diagnoses established with combined conventional test-ing were detected on EUS with upper endoscopy.Additionally,EUS resolved the etiology of a low lower esophageal sphincter pressure in two symptomatic pa-tients and detected the additional diagnoses of slippage in two subjects.Among asymptomatic subjects,EUS identified additional diagnoses in two subjects consid-ered to be normal by conventional testing methods.Conclusion:According to the findings,EUS is a feasible method for evaluating post-Nissen fundoplication hiatal anatomic relationships.The combination of EUS and EGD allows the mechanism of failure to be detected in patients presenting with postoperative symptoms after Nissen fundoplication.
Key words:Antireflux surgery —Endoscopic ultra-sound —Failure —Gastroesophageal reflux disease —Nissen fundoplication —Reoperation
The introduction of minimally invasive techniques has,in part,been responsible for an almost threefold increase in the number of Nissen fundoplications performed over the past 12years [4].Although Nissen fundoplication has proved to be a very effective and durable treatment for gastroesophageal reflux disease (GERD)[2],up to 17%of patients experience persistent,new-onset,o
r recurrent symptoms.Although some symptoms of dys-phagia,bloating,and mild residual esophagitis are not uncommon in the early postoperative period,symptoms that are severe or persist beyond 3months may indicate failure.Of those with symptoms after surgery,2%to 6%will ultimately require reoperation [6,9,13,16,18].Determining the exact mechanism of failure is fun-damental to providing optimal results with reoperative surgery.If the anatomic and physiologic reasons for
Presented at the annual scientific session of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES),28April 2006,Dallas,TX,USA
泌尿生殖Correspondence to:B.A.
Jobe
Surg Endosc (2007)21:1719–1725DOI:10.1007/s00464-007-9234-8
ÓSpringer Science +Business Media,LLC 2007
failure are not identified before reoperation,there is a high likelihood that the second operation will also fail or that the existing symptoms will not improve with sur-gical intervention[7].Additionally,the probability of a successful outcome after reoperative antireflux surgery diminishes with each successive attempt,falling to66% after the third and50%after the fourth operation[15]. The need to maximize the likelihood of success at the initial redo procedure is therefore paramount.
Currently,the workup of patients who present with symptoms after antireflux surgery comprises the same elements as the initial preoperative evaluation:ambu-latory24-h pH monitoring,esophageal manometry, esophagram,and esophagogastroduodenoscopy(EGD). However,the usefulness of these indirect tests for eval-uating a potentially failed procedure is limited by their low accuracy.As compared with intraoperativefindings, they are inaccurate in up to40%of cases[8].
Furthermore,whereas each test provides important information regarding the physiology at the esophag-ogastric junction and hiatus,none demonstrates ana-tomic detail through direct cross-sectional imaging. Because fundoplication failure is potentially mechanical in nature,detailed anatomi
c imaging may prove to be critical in making the diagnosis.Most commonly,the precise mechanism of fundoplication failure is deter-mined at the time of reoperation,leaving no time for counseling patients or planning for an esophageal-
lengthening procedure.
The known causes of failure after Nissen fundopli-cation include dehiscence,herniation,an overly tight fundoplication or crural closure,slippage or misplace-ment of the fundoplication onto the body of the stom-ach,and a loose but intact repair.We have previously shown that these mechanisms of failure can be surgically reproduced in a swine model and characterized using a defined set of endosonographic criteria(Fig.1)[5].We hypothesize that these same endoscopic ultrasound (EUS)criteria can be applied to humans and will facil-itate a more precise means of diagnosing the mechanical defect in patients presenting with foregut symptoms after Nissen fundoplication.
Materials and methods
Study overview,patient selection,and data collection The study protocol was approved by the institutional review boards of Oregon Health and Science University and the Portland VA Medical Center.Informed consent was obtained by trained research personnel. This prospective trial was a bli整合营销论文
nded comparison between conventional testing and EUS in determining the anatomic integrity of a Nissen fundoplication in symptomatic and asymptomatic patients.
All patients older than18years who had undergone Nissen fundoplication were eligible for enrollment in the study.The exclusion criteria specified pregnancy,prior reoperative antireflux surgery, esophageal or gastric malignancy,anticoagulation therapy,ZenkerÕs diverticulum,esophageal varices,head or neck malignancy,or medical frailty.
Patients experiencing new-onset,recurrent,or persistent foregut symptoms after laparoscopic or open Nissen fundoplication were identified in the clinic over a4-month period and approached for study enrollment.Asymptomatic patients who had undergone either lapa-roscopic or open Nissen fundoplication were selected from a pro-spectively collected outcomes database.For a patient to be considered asymptomatic,it was required that there be no history of heartburn, regurgitation,dysphagia,extraesophageal reflux symptoms,or Nissen-related symptoms such a gas bloat or persistent postprocedural dys-phagia.Asymptomatic patients had to be free of antisecretory medi-cation use.
Demographics(age,gender,race),use of antisecretory medica-tions,time since surgery,and body mas
s index were collected on all subjects by interview.For symptomatic patients,duration and type of postoperative symptoms,whether an inciting event such as emesis or heavy lifting preceded the onset of symptoms,and postsurgical inter-ventions were recorded.Two validated GERD questionnaires,the Reflux Symptom Index(RSI)[3]and the GERD Health Related Quality of Life Questionnaire(GERD-HRQL)[17],were administered to all subjects at the initial visit.All patients underwent esophageal manometry,ambulatory24-h pH monitoring,esophagram,and EGD followed by EUS.
Study procedures
岩盐弹
Manometry was performed using a solid-state system(Sandhill Sci-entific,Inc.,Highlands Ranch,CO,USA).A stationary pull-through technique was used to measure the lower esophageal sphincter(LES) pressure,length,and position using established criteria[1].Esophageal body motility was evaluated with ten5-ml swallows of water over a stationaryfive-channel catheter.
Ambulatory24-h pH monitoring(Sandhill Scientific)was per-formed with a transnasal catheter-based system,and the probe was placed5cm proximal to the upper boarder of the manometric LES. Patients were instructed to maintain a diary and to record symptoms by pressing the event button on
the data-logging device,which were subsequently correlated with pH data.The time that the pH was less than4and the DeMeester score were recorded for each patient.
A contrast esophagram was performed and interpreted by a radiologist and participating investigator.The position of the fundo-plication in relation to the diaphragm and proximal stomach was re-corded.The location of the fundoplication was considered the point at which the distal esophagus became narrowed by the repair.If there was no evidence of a fundoplication,the location of the
esophagogastric Fig.1.Endoscopic ultrasound image of an intact Nissen fundoplica-tion in the swine model.The characteristicfive-layer pattern formed by the layers of the esophagus and fundoplication is one hallmark of a properly performed fundoplication.Reprinted from Gopal et al.(2006) EUS characteristics of Nissen fundoplication:normal appearance and mechanisms of failure.Gastrointest Endosc63:35–44.
1720
junction in relation to the diaphragm was identified.Esophageal emptying time and diameter were recorded.
With the patient under conscious sedation,EGD was performed using a 9.8-mm GIF140flexible endoscope (Olympus America Corp.,Melville,NY,USA).Established criteria were used to grade the integrity and position of valve reconstruction after Nissen fundopli-cation [10].The presence of esophagitis was recorded and graded using the Los Angeles Classification [11].
After endoscopic findings had been recorded,EUS of the esoph-agogastric junction was performed with a GF UM-120or UM-130echoendoscope (Olympus America Corp.)at 5to 20MHz.The ability of EUS to determine the anatomic relationship between the fundo-plication and the esophagus and bet
ween the fundoplication and hiatal opening was tested.To accomplish this,we tried to identify the tran-sition from thoracic to abdominal cavities,the apex of the hiatal opening,and the right and left bundles of the right crus.
The intraabdominal esophageal length was measured as the dis-tance from the hiatal opening to the esophagogastric junction.The esophagogastric junction was defined by the appearance of the echo-genic gastric serosa on gradual introduction of the echoendoscope.The length and position of the fundoplication was determined by measur-ing the cranial-to-caudal distance of the characteristic five-layer pat-tern of the fundoplication in relation to the esophagus and esophageal hiatus (Fig.2).The circumferential integrity of the repair was deter-mined by identifying the extent of the five-layer pattern with axial rotation of the echoendoscope or by visualizing the union of the right and left limbs of the fundoplication.
The greatest diameter of the crural opening was measured.All end points were collected onto preprinted forms specifically designed for data ascertainment.
Interpretation of conventional and endosonographic testing and blinding
The potential diagnoses included normal,slipped or misplaced,her-niated,dehiscence,tight,or loose f
undoplication.At completion of the trial,the results of conventional testing were analyzed,and a diagnosis was rendered according to the interpretation of all tests (EGD,UGI,manometry,ambulatory 24-h pH testing)combined.An investigator blinded to patient symptoms,medication use,and all other conven-tional test results performed EGD followed by EUS.
Before EUS,EGD was performed,and an impression was re-corded.The interpretation of the EGD was not subsequently modified on the basis of the EUS results.However,because these two proce-dures are uniformly performed together,the EUS diagnosis was made with knowledge of the upper endoscopy result.The specific conven-tional and EUS end points that determined the diagnoses for this trial are listed in Table 1.
Results
The study enrolled seven symptomatic and nine asymptomatic patients who met the inclusion criteria.All the subjects completed the study.Age,gender,race,and body mass index did not differ significantly between the two groups (Table 2).The median postoperative follow-up period was 4years (range,2–30years)in the symptomatic group and 2years (range,1–4years)in the symptomatic group.
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All the symptomatic patients required treatment with proton pump inhibitors.Two symptomatic patients reported their overall satisfaction with their present condition as that of being ‘‘satisfied.’’The remainder reported it as that of being ‘‘dissatisfied.’’The majority of symptomatic patients reported heartburn as their primary symptom (Table 3).Dysphagia was reported as a primary symptom in one patient and as a secondary symptom in two patients.All patients in the asymp-tomatic group reported their overall satisfaction with the results as that of being ‘‘very satisfied’’or ‘‘satis-fied,’’and none were taking proton pump inhibitors.Endoscopic ultrasound was successfully completed for all 16patients without complication.The right and left bundles of the right crus,anterior diaphragmatic arch,thoracic vs abdominal cavity,distal esophagus,esophagogastric junction,and proximal stomach were identified in each patient.The endosonographer was able to identify the following hiatal anatomic relation-ships directly in all patients:fundoplication position relative to diaphragmatic hiatus,fundoplication posi-tion relative to the esophagogastric junction,fundopli-cation length,and circumferential integrity of the repair.The previously determined criteria were technically feasible and applicable for the evaluation of Nissen fundoplication in humans (Table 1).Symptomatic subjects
Using the results of the conventional studies (including EGD),diagnoses were rendered for each symptomatic patient and compared with diagnoses rendered on the basis of EUS and EGD (Table 3).
At postoperative testing,every symptomatic patient had evidence of ana-tomic failure.All the diagnoses rendered on the basis of combined conventional testing also were observed on combined EGD and EUS examination.In addition,four additional diagnoses established with EGD and EUS had been either entirely missed or ambiguous at con-ventional testing.Although pH monitoring was at-tempted for all the patients,two did not complete the test due to premature expulsion of the pH catheter.For the remaining five patients,pH monitoring did not
contrib-
Fig.2.Endoscopic ultrasound image of an intact Nissen fundoplica-tion in a study subject.The five-layer pattern seen in the swine model is reproduced in the human subject.
1721
ute any diagnostic information that caused a change in the combined conventional testing interpretation.
Although the exact etiology could not be deter-mined,three symptomatic patients demonstrated a hypotensive LES on manometry.For these patients, EUS resolved the ambiguity in diagnosis as either dehiscence(partial or complete)or looseness of a cir-cumferentially intact fundoplication.Additionally,EUS detected complete or partial dehiscence in two patients who appeared to have adequate LES pressure on manometry(Fig.3).Slippage and herniation of the fundoplication was detected by EUS in two patients. For the one subject,esophagram was interpreted as a ‘‘small paraesophageal hernia,’’and for the other,the esophagram was normal.
Asymptomatic subjects
For six of the nine asymptomatic subjects,EUS examination was able to establish the hallmarks of a properly performed Nissen fundoplication,and a normal diagnosis was rendered(Table4).This con-curred with thefindings of the combined conventional studies.In one subject,EUS detected herniation, which concurred with thefindings of combined con-ventional testing.Endoscopic ultrasound also detected abnormalities in two asymptomatic patients for whom the conventional set of tests did not.One of these patients was found to have a partial dehiscence,and the other was discovered to have slippage and partial dehiscence.
Discussion
As a high-resolution and direct cross-sectional imaging method,EUS combined with EGD demonstrates the potential to evaluate patients with persistent or recur-rent symptoms after undergoing Nissen fundoplication. The ability of EUS to identify the complex anatomic relationships between the esophagogastric junction,the fundoplication,the diaphragmatic hiatus,and the body of the stomach make it well suited for identifying the mechanical disruptions associated with Nissen fundo-plication.In previously reported studies using a swine model,we have described specific endosonographic cri-teria that characterize a properly performed Nissen fundoplication and a number of anatomic derangements associated with repair failure[5].The current study demonstrates t
hat EUS also can be readily applied in human subjects.
Table1.Criteria used for the diagnoses based on each study method
Diagnosis Manometry Esophagram EGD PH EUS[5]
Slipped None Tapering or‘‘waist’’
distal to EGJ Gastric rugae proximal
to‘‘waist’’created
by fundoplication
+/)Thick innermost layer,
surrounded by an echogenic
serosal layer(gastric wall);
echogenic serosal layer noted
proximal to upper border
of fundoplication
Dehiscence Absent or low LESP a;
short LES b Lack of tapering at
distal esophagus
Complete absence of valve
on retroflexion exam
+Anterior defect in the360°
5-layer pattern
Herniation Completely
intrathoracic LES Intrathoracic tapering
or‘‘waist’’
EGJ or fundoplication
proximal to crural pinch
+/)Five-layer pattern or EGJ
identified proximal to
diaphragmatic hiatus
Loose Absent or low LESP;
Short LES Reflux through intact
fundoplication
Patulous cardia,abnormal
valve geometry[10]
+Passage of fully inflated
echoendoscope balloon
without resistance plus an
intact360°5-layer pattern
Tight High LESP,
Long LES c Retention of contrast,
proximal esophageal
dilation
Resistance with passage of
endoscope through EGJ:
presence of valve
)
Thickened esophageal wall
from compression;obliteration
of space between esophagus and
fundoplication;thinned gastric
walls of tight fundoplication
Normal Normal LESP
and length Tapering below diaphragm
and proximal to EGJ
Normal valve geometry[10]
distal to crural pinch
)360°5-layer pattern around
distal esophagus for a length
of2.5cm within the abdomen;
greatest hiatal diameter is similar
to esophageal diameter
EGD,esophagogastroduodenoscopy;EUS,endoscopic ultrasound;EGJ,esophagogastric junction;LES,lower esophageal sphincter;LESP,lower esophageal sphincter pressure
a Low LESP(<10mmHg)
b Short LES(<1cm intraabdominally or<2cm total length),positive pH test(DeMeester score>14.7)
c Long LES(>6cm)
Table2.Patient characteristics
Symptomatic (n=7)Control (n=9)
Mean age:years(range)68(30–81)57(40–67) Males78
Median follow-up:years(range)4(2–35) 2.5(1–4) Median BMI:kg/m2(range)25(25–40)31(26–39) Median ASA classification22
BMI,body mass index;ASA,American Society of Anesthesiology 1722
In this series of symptomatic patients,EUS detected or clarified four additional diagnoses compared with the standard set of conventional tests combined.These re-sults suggest that EUS has a greater ability to detect the specific mechanisms of fundoplication failure in symp-tomatic patients.Thus,EUS may be particularly useful for evaluating postfundoplication patients for whom conventional studies have yielded no anatomic cause to explain symptoms.For these patients,EUS may offer a means to detect an abnormality that supports the symptoms and offers the basis for intervention.It is for this subset of patients that EUS may find application and affect clinical decision making.
In addition,the results of this study suggest that EUS combined with EGD may represent the only test-ing required to guide the decision to operate or not.The ‘‘single study (EGD +EUS)’’approach would pose less discomfort and inconvenience for the patient,but its effectiveness will need to be established in a larger investigation that incorporates outcomes after reopera-tive surgery.
In the asymptomatic group,we identified three anatomic abnormalities in three different patients,nam
ely,a slipped fundoplication,a herniation,and a small dehiscence.It is possible that these findings are attributable to sonographic artifacts.An alternative explanation is that these findings represent anatomic abnormalities that have not caused symptoms.Because the incidence of anatomic derangements in asymptom-atic patients after Nissen fundoplication is unknown,it would be difficult to determine whether these findings are subclinical diagnoses or artifacts related to EUS.In asymptomatic patients,surgical verification would not be feasible.
As with other types of ultrasonography,EUS is operator dependent and subject to examiner experience深圳
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T a p e r i n g b e l o w d i a p h r a g m ,p r o x i m a l t o E G J H ,L ,E
H ,L ,E ,S I D ,i d e n t i fic a t i o n n u m b e r ;L E S P ,l o w e r e s o p h a g e a l s p h i n c t e r p r e s s u r e ;L E S ,l o w e r e s o p h a g e a l s p h i n c t e r ;E G D ,e s o p h a g o g a s t r o d u o d e n o s c o p y ;U G I ,u p p e r g a s t r o i n t e s t i n a l s e r i e s ;E U S ,e n d o s c o p i c u l t r a s o u n d ;H ,h e r n i a t i o n ;D ,d e h i s c e n c e (p a r t i a l o r c o m p l e t e );L ,l o o s e ;s ,s l i p p e d ;E ,e s o p h a g i t i s ;R i n g ,S c h a t z k i Õs r i n g a D i a g n o s e s d e t e c t e d b y E U S b u t n o t b y c o n v e n t i o n a l t e s t i n g a r e i n d i c a t e d i n b o l
d
Fig.3.Endoscopic ultrasound image of Nissen fundoplication dehis-cence in a symptomatic subject.
1723
with interpretation of ultrasound images[12,14].In the current study,EUS was performed and interpreted by a specialist experienced in foregut endosonography at a tertiary referral center.Whether the results can be gen-eralized to community centers with smaller volumes of patients remains to be seen.
Although all symptomatic patients were found to have a mechanical failure of the fundoplication,at this writing,none have undergone reoperation.Without operative inspection,no gold standard was available to determine the sensitivity and specificity of EUS.A study enrolling a larger number of symptomatic patients would be valuable for correlating EUSfindings with operativefindings.Moreover,such a study would pro-vide insight concerning the ability of EUS to predict improvement in symptoms after reoperation. Acknowledgment.This work was funded by a grant from the Society of American Gastrointestinal and Endoscopic Surgeons(BAJ).It was supported in part by National Institutes of Health grant K23 DK066165-02(BAJ).
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Table4.Results from studies of asymptomatic patients and diagnoses rendered a
ID DeMeester
score
Resting
LESP
(mmHg)
Abdominal
LES length
(cm)
造船生产
设计Thoracic
LES length
(cm)EGD UGI
Conventional
Testing
diagnoses
EGD
and EUS
diagnoses
1412.5 4.5 1.0Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N N
2530.2 3.0 1.0Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N N 3615.5 3.5 1.5Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N N 4127.8 5.5 2.5Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N N
5Declined14.8 4.0 1.5Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N N
611870.5Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N S,D 7119.3 4.5 2.0Normal valve geometry Not available N N
8119.1 6.0 1.0EGJ proximal to crural
pinch Tapering below diaphragm,
proximal to EGJ
H H
91154 1.0Normal valve geometry Tapering below diaphragm,
proximal to EGJ
N D
ID,identification number;LESP,lower esophageal sphincter pressure;LES,lower esophageal sphincter;EGD,esophagogastroduodenoscopy; UGI,upper gastrointestinal series;EUS,endoscopic ultrasound;N,normal;S,slipped;D,dehiscence(partial or complete);H,herniation
a Diagnoses detected by EUS but not by conventional testing are indicated in bold
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