Efficacy and Safety of the Luso-Cor Esophageal Stent Compared to Other Endoscopic Techniques in the Management of Fistulas and Anastomotic Dehiscences After Upper Digestive Tract Surgery (ES-LCCE-UDFM)
Conditions: Obesity, Obesity, Morbid, Esophageal Cancer, Esophageal Neoplasms, Gastric Cancer, Gastric Adenocarcinoma, Fistula, Dehiscence, Anastomotic Leak, Anastomotic Leak Esophagus, Dehiscence; Postoperative
Sponsor: Unidade Local de Saúde Santa Maria

Efficacy and safety of the Luso-CorÒ esophageal stent compared to other
endoscopic techniques in the management of fistulas and anastomotic
dehiscences after upper digestive tract surgery (ES-LCCE-UDFM)
21st February 2025

Efficacy and safety of the Luso-CorÒ esophageal stent compared to other
endoscopic techniques in the management of fistulas and anastomotic
dehiscences after upper digestive tract surgery (ES-LCCE-UDFM)
Introduction
The global prevalence of obesity has prompted an increase in bariatric surgery, which is
the only management strategy that provides long-term weight loss and improvement of
obesity-related diseases.1,2,3 Bariatric surgeries include sleeve gastrectomy(SG), Roux-
en-Y gastric bypass(RYGB),and laparoscopically adjustable gastric banding(LAGB).1
The incidence of adverse events depends on the type of bariatric surgery performed,
with serious adverse events occurring in approximately 4% and mortality in 0.1%
patients.1,4,5 The incidence of fistulas after SG varies between 0.2% to 2.5% and
between 1% and 4.9% in patients who have undergone an RYGB.1,2,5,6,7,8 The incidence
of strictures after SG is approximately 0.35%.6 Older, more obese, and male patients
with multiple comorbidities related to obesity are at increased risk for the development
of fistulas and mortality following bariatric surgery.7,9,10Additionally, reoperative
surgery after LAGB increases the risk of complications.7,10
The morbidity and mortality related to adverse events increases with surgical re-
exploration at the site of a fistula orifice,8,9,10,11. For this reason, management of fistulas
after bariatric surgery has shifted from a surgical to a primarily endoscopic approach,
primarily with covered metallic stents, with fistula closure success rates between 75%
and 100%.1,2,12,13 However, a primarily endoscopic approach is demanding in terms of

resource use, and the high incidence of stent migration often requires multiple
reinterventions — both endoscopically and surgically.2,11,14,15
The Luso-CorÒ esophageal stent was designed to take into account altered anatomy
after bariatric surgery and to overcome strictures in the gastric tube, which can be
concomitantly present in patients with fistulas following SG. A pilot study involving 15
patients with fistulas after sleeve gastrectomy managed with the Luso-CorÒ esophageal
stent showed a 100% rate of fistula closure, low rate of adverse events with only one
episode of stent dysfunction16.
A recent meta-analysis suggested that endoscopic vacuum therapy (EVT) was
associated with a 21% increase in successful fistula closure compared to self expanding
metallic stents (RD 0.21, CI 0.10-0.32; P = 0.0003), a 12% reduction in mortality
compared to stenting (RD 0.12, CI 0.03-0.21; P = 0.006) and an average reduction of
14.22 days in duration of treatment (CI 8.38-20.07; P < 0.00001). Additionally, EVT
was associated with a 24% reduction in adverse events (RD 0.24, CI 0.13-0.35; P =
0.0001. There were no statistical differences between the studied therapies regarding the
length of hospital stay17.
Therefore, in this study, we aimed to evaluate and compare the success of the novel
Luso-Cor esophageal stent® in the exclusion of fistulas, reinterventions, stent-related
adverse events, duration of hospitalization and its efficacy in the management of fistulas
after SG compared to other stents or EVT.

Hypothesis of the study
The novel concept of esophageal anchoring of a specially designed long stent may be useful in
management of fistulas after gastric surgery with high success rate and minimal morbidity
compared to conventionally available esophageal or bariatric surgery stents and EVT.
Objectives of the study
To evaluate and compare the performance of the Luso-Cor® oesophageal stent with other
stents or EVT in management of fistulas after bariatric and oncologic surgery on the upper
digestive tract with regard to:
- Technical success defined as successful deployment of the stent at the desired location and
exclusion of the fistula orifice.
- Clinical efficacy defined as successful closure of the fistula orifice after stent removal.
- Safety – Early and late adverse events related to stent placement.
-Duration of hospitalization
- Number of endoscopic procedures required till fistula closure
- Mortality

Inclusion criteria
Patients undergoing endoscopic management of fistulas after bariatric surgery or dehiscences
of esophago-jejunal or gastro-jejunal anastomosis after esophageal or gastric oncologic
surgery will be included in the study.
Exclusion criteria
- Pregnancy
- Age < 18years
- Inability to give informed consent.
Type of study: Prospective observational multicentre study,
Materials and methods
Conventional covered metallic and bariatric surgery stents and EVT will be used as per
standard of care.
Design features of the Luso-Cor® esophageal stent: This is a specifically designed stent to
manage fistulas after sleeve gastrectomy, Roux-en-Y gastric bypass and esophago-jejunal
anastomotic dehiscences after total gastrectomy.
This metallic stent measuring 24 cm in
length is covered with silicone and has three sections: 1) A proximal flared portion with
diameters of 30, 34 and 36 mm measuring 6 cm in length; 2) Middle narrow portion with a

fixed diameter of 20 mm measuring 16 cm in length; and 3) Distal flared portion with a fixed
diameter of 30 mm measuring 2 cm in length.
Esophageal anchoring, is achieved through the larger diameter of the proximal flared portion
compared to conventional stents and a 5 mm uncovered portion located 1 cm below the
proximal edge of the stent. The remainder of the stent is covered with a thin silicone coating.
This contrasts with the conventional partially covered metallic esophageal stents which usually
have at least 1 cm of uncovered portions near the proximal and distal edges.
There are two zones within the middle narrowed portion of the stent which allow articulation
of the stent on itself up to 90º. This allows the stent to adapt to altered anatomy and
peristaltic activity of the foregut. The distal flared portion of the stent is designed to be placed
in the gastric antrum or in the proximal jejunum, to avoid peri-stent reflux of enteric fluid.
Radio-opaque markers are placed at the proximal and distal edge of the stent and at the
junction of the proximal flared portion with the middle narrow portion, unlike conventional
metallic esophageal where the radio-opaque markers are placed at the stent edges and in the
middle.
Stent placement: Placement of the stent is done by over the wire technique and ideally with X-
ray imaging control. It can also be done with endoscopic control by the bedside in
emergencies. The distal edge of the stent should be placed at least 2 cm proximal to the
pylorus and the proximal flared portion should be placed in the distal esophagus, at least 2 cm
above the esophago-gastric junction or esophago-jejunal anastomosis. During stent delivery,
after verifying opening of the distal flare of the stent near the pylorus, the endoscopist should
focus on the radio-opaque markers in the proximal portion of the stent which are separated by
6 cm so that the proximal flare is liberated in the distal third of the esophagus.

Due to the usually smaller diameter of the esophagus in women, we recommend the use of
the Luso-CorÒ esophageal stent with proximal flare of 30 mm diameter in women and 34 and
36 mm diameters in men. However, the endoscopist should choose the ideal diameter based
on the endoscopic assessment of the esophageal lumen diameter prior to stent placement.
After deployment, the stent should be kept in place for at least 4 weeks and up to a maximum
of 12 weeks. An oral contrast study should be done 48 to 72 hoursafter stent deployment to
confirm effective exclusion of fistula orifice after which oral dietary intake may be
commenced. All patients should receive proton pump inhibitors (PPIs) twice a day with a
recommendation for head elevation in the supine position to decrease reflux esophagitis.
Stent Removal: Stent removal is easy compared to conventional stents. It requires ablation of
the mucosal ingrowth in the 5mm uncovered portion near the proximal edge of the stent with
argon plasma 50W/1L, followed by scraping of the tissue with a cap applied at the tip of the
endoscope and capture of the drawstring at the proximal edge of the stent with a rat tooth
forceps.
Clinical data and management strategy of patients with fistulas or anastomotic dehiscences:
The type of stent used or option for use of EVT as first line endoscopic option will be at the
discretion of the endoscopist.
The Luso-Cor® esophageal stent was approved for clinical use in Portugal in 2016 by regulatory
authorities (INFARMED).
After diagnosis of fistulas, whenever required, patients should undergo surgical peritoneal
toillete either by laparotomy or laparoscopy with placement of abdominal drains.

Informed consent for endoscopic procedures to manage fistulas or anastomotic dehiscences
will be obtained from all patients.
The location and size of the fistula orifice will be determined and the presence of concomitant
stricture of the gastric tube noted endoscopically.
Fistulas will be considered as acute if endoscopy was performed within one month of surgery
and chronic if performed >1 month after surgery.
Whenever possible, the fistula orifice will be closed with either through the scope clips(TTSCs)
or the over the scope clips(OTSCs). Small fistula orifices measuring <5 mm will be initially
managed with either TTSCs or OTSCs.
The Luso-CorÒ esophageal stent may be used as the first option in patients with fistula
orifices >5 mm either alone or in combination with OTSCs or TTSCs, in those patients who have
fistula persistence after initial application of TTSCs or OTSCs or in those with concomitant
stricture in the gastric tube detected endoscopically.
Gastroesophageal reflux disease after stent placement will be managed with double dose PPI
and sucralfate 1g up to 4 times a day.
Definitions
Technical success will be defined as correct placement and coaptation of the stent at the
previously planned location under fluoroscopic imaging with radio-opaque markers with
effective exclusion of fistula orifice.
Clinical efficacy will be defined as closure of the fistula orifice after Luso-CorÒ esophageal stent
removal. Definitive closure of the fistula orifice should be confirmed by contrast injection
during endoscopy and / or oral contrast study after Luso-CorÒesophageal stent removal.

A secondary endpoint of clinical efficacy will be the effectiveness of the Luso-CorÒ esophageal
stent or other stents in managing fistulas in the gastric tube after vertical gastrectomy.
Stent related adverse events will be defined as early (within 1 week of stent placement) and
late (> 1 week after stent placement) and include stent migration, perforation, hemorrhage,
stent fracture and mortality.
Primary outcome for this study will be closure of the fistula orifice after stent removal.
Secondary outcomes will be effectiveness of the stent in managing strictures in the gastric
tube, stent-related adverse events, number of endoscopies, motives for endoscopic
reinterventions and the number of stents used, duration of hospitalization and fistula or stent-
related mortality.
Simple fistulas will be defined as fistulas communicating between a hollow organ and the
peritoneum or pleura (Gastro-pleural or gastro-peritoneal).
Complex fistulas will be defined as fistulas communicating between two hollow organs
(Gastro-bronquial) or between a hollow organ and the skin (Gastro-cutaneous) or those with
sub-divisions and multiple trajectories in continuity with a fistula orifice.
All procedures will be performed in accordance with the ethical standards of the institution
and with the 1964 Helsinki declaration.
Statistical Analysis
Qualitative data will be presented as percentages and quantitative data as median (Min-Max).
Factors at baseline predicting technical success, clinical success, clinical efficacy and
development of adverse events will be evaluated using the Logistic regression analysis.

Qualitative data will be compared with the Chi-square test and quantitative data will be
compared with the Student´s t test or Mann-Whitney test if the distribution is normal or non-
normal.
Multivariate analysis will take into account all factors at baseline associated with the outcomes
measured (p<0,1) and will be performed using the backward stepwise regression.
A p value <0,05 will be considered statistically significant.
Data will be analyzed using IBMÒ SPSS 21 (SPSS Inc., Chicago, IL, USA).
Parameters analyzed in the study: Please refer to Case Report Form (CRF)
Study Chronogram
December 2023 – Ethics committee approval
January 2024 to January 2025 – Implementation of the study.
January 2025 to April 2025 – Data analysis
May to October 2025 – Publication of the study results and presentation of data at national
and international scientific meetings
Potential benefits from the study

This observational study aims to compare the efficacy and safety of the main forms of
endoscopic management of fistulas and anastomotic dehiscences after bariatric and
oncologic surgery in the upper digestive tract.


The new concept of esophageal anchoring of the Luso-Cor ® esophageal stent and the
two articulated segments in the middle portion of the stent should improve the
adaptability of the stent to altered anatomy and decrease the risk of migration.

The new stent design will probably decrease the number of endoscopies required to
manage fistulas after bariatric surgery and esophago-jejunal and esophago-gastric
anastomotic dehiscences and may decrease the number of adverse events many of
whom are related with migration of conventional esophageal stents.

The reduction of endoscopies required to manage the fistulas and potential early
resumption of oral feeding and shorter hospitalization with the Luso-Cor esophageal
stent compared to conventional stents and EVT should improve the cost efficacy of
fistula management.

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