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Endoscopic internal drainage

Bariatric leaks: Is endoscopic internal drainage the gold standard?

Defect of the staple line, after Sleeve Gastrectomy, with inflamed edges, surfaced of metallic stapler pins and open surgical stitches
From an endoscopic point of view, leak and fistula share similar features: a defect of the staple line or an anastomotic dehiscence often with inflamed edges, sometimes with spillage of pus or surfaced metallic stapler pins or open surgical stitches
In our experience, such complications are even increased by the use of newly designed “mega-stent”

This article was authored by: Gianfranco Donatelli, Interventional Endoscopy & Endoscopic Surgery, Hôpital Privé des Peupliers, Paris, France

Leaks and fistula following obesity surgery, mainly Sleeve Gastrectomy and Gastric Bypass, still represent an important issue with an overall incidence of 2 % worldwide. Leak is defined as a fluid collection through a defect of the staple line or an anastomotic dehiscence (Figure1 a,b); whereas fistula is an abnormal communication between two re-epithelized structures such as: gastro bronchial, gastro-gastric, gastro-colic, gastro-jejunal, or gastro-cutaneous (Figure 2).

Figure 1a: “Leak” defined as a fluid collection through a defect of the staple line or an anastomotic dehiscence - leak following Sleeve Gastrectomy

Figure 1b: “Leak” defined as a fluid collection through a defect of the staple line or an anastomotic dehiscence - leak following Gastric bypass

Figure 2: Gastro-Bronchial “Fistula” (red arrow) defined as an abnormal communication between two re-epithelised structures following Sleeve Gastrectomy (Yellow arrow)

The gold standard for the diagnosis of leak and fistula are radiological studies highlighting contrast medium extravasation or an abnormal communication with other viscera. Swallow CT scan is mandatory if a leak is suspected.

From an endoscopic point of view, leak and fistula share similar features: a defect of the staple line or an anastomotic dehiscence often with inflamed edges, sometimes with spillage of pus or surfaced metallic stapler pins or open surgical stitches (Figure 3). 

Figure 3: Defect of the staple line, after Sleeve Gastrectomy, with inflamed edges, surfaced of metallic stapler pins and open surgical stitches

The timing of onset is not a criterium to differentiate leaks from fistulae; however is very rare to have an early fistula because almost all fistula are chronic and leaks are most often early but may become chronic if the first treatment, generally endoscopic, fails. Acute symptoms are tachycardia, fever, pain and sepsis with local or generalized peritonitis whereas chronic symptoms are mainly unexplained cough, skin or enteral fluid spillage, excessive weight loss or weight regain. 

Hyper-pressure, ischemia, high dissection of His angle (in sleeve gastrectomy) are considered as technical risk factors whereas early re-alimentation and inappropriate diet may contribute as well in the development of leaks and fistula.

Patients with sepsis need emergency surgical evaluation with exploration of peritoneal cavity and complete drainage of the fluid collection close to the defect coupled with a jejunostomy. Direct suture of the defect does not seem to be useful due to tissues inflammation. 

Endoscopy plays an important role both in the diagnostic work up and in the management of these complications. Since 1990’s fully covered self-expandable metal stents (FCSEMS) had been used to by-pass the defect thus allowing early oral intake. Overall success rate of around 80% has been reported in literature.

Before stent deployment it is mandatory to drain any abdominal collection (surgically or radiologically) It would be hazardous to deliver a FCSEMS for the treatment of a leak if a fluid collection is present. An abscess cannot be treated by isolating it.

Unfortunately, several adverse events have been reported.

The most common one is stent migration. Such complication is very common if no concomitant stricture is present. Moreover, even when a stricture is present, usually in case of Sleeve Gastrectomy it is often a functional one, namely Helix twist. If a helix twist is present, deployment of FCSEMS may even worsen the symptomatology. The stent is effective in dilating a stricture but is unable to solve the twist of the gastric tube (Figure 4).

Figure 4: Functional Helix Stenosis, in a patient underwent Sleeve Gastrectomy, with FCSEMS in place, twisted itself on the gastric tube axis

On the contrary FCSEMS rather tend to twist themselves on the gastric tube axis. In such condition, the key point is to « de-twist » and/or reduce hyper-pressure of the helix.

Refilling of the leak has also been reported. This may occur because FCSEMS does not guarantee a watertight sealing. 

Tissue ingrowth with stent occlusion at the distal edge and gastro-Intestinal perforation may occur as well after stent deployment, and even some ancillary case of aorta rupture leaving to death have also been reported.

In our experience, such complications are even increased by the use of newly designed “mega-stent”. Being larger and longer they may induce local ischemia due to higher radial force and facilitate tissue ingrowth due their firm fixation. Different authors have proposed other endoscopic techniques, namely Over the scope clip (OTSC) and flexible suturing devices, for the sealing of leaks and fistula following bariatric surgery.

Such techniques have been proven effective in the management of acute GI wall defect.

However similarly to surgical stitches these endoscopic techniques fail in the vast majority of the cases due to tissue inflammation. Moreover, from a physiologic point of view, being the inflammatory cascade already activated, trying to seal the defect is inappropriate because the healing process would tend to reject any foreign material with wall defect persistence.

Direct or Endoscopic Ultrasound guided Internal Drainage of pancreatic pseudocyst and endoscopic necrosectomy of walled off necrosis have recently become the gold standard  for peripancreatic “third space” fluid collections following pancreatitis.

Therefore, why do not we consider the “third space” of the perigastric collection following leaks in the same way that we look at peri-pancreatic fluid collection and successful treat them with the same approach?

Since 2013 we introduced in our endoscopic tertiary centre the endsocopic internal drainage (EID) – deployment of double pigtail plastic stent (DPS) across the defect of any peri-gastric fluid collection following obesity surgery (Figure 5).

Figure 5: Endsocopic internal drainage (EID) of peri-gastric fluid collection following obesity surgery, by deployment of double pigtail plastic stent (DPS) across the defect

The aim was to achieve intra GI tract fluid drainage, promoting collapse of the “third space” and secondary granulation tissue formation. DPS works like a foreign body, rapidly permitting to remove any surgical drainage. Early surgical drain removal is fundamental to reduce the incidence of chronic fistula formation along the drainage tract. For the first four-weeks a naso-jejunal feeding tube is delivered to by-pass the defect and permits an optimal caloric intake to favourite healing process. At four weeks, systematic control is carried out.  If sepsis is solved pigtails drains are left and oral intake is introduced. Stents are, in most cases, definitely remove after three months.

Some authors modified EID technique deploying several DPS across the leak in order to occlude the defect thus allowing early oral intake or considering defect larger than 2 cm as a contraindication to EID.

In my personal experience, I do believe that EID may be effective even for defect larger than 2 cm.

Technical success rate of EID is very high amounting to 93% of patients. Whenever the defect is not visible (around 6% of the cases) EID may be still carried out with EUS guidance (Figure 6).

Figure 6,b,c,d,e: EUS drainage of peri-gastric collection. Yellow arrow: Normal Sleeve Gastrctomy with no defect. Red arrow: EUS Peri-gastric puncture

In such cases EUS may be used to create a communication between the GI lumen and the perigastric collection. EID failure is rare (around 1 %) and is mainly related to the presence of long standing collection with semi-solid necrosis.

Our attitude in case of leak following obesity surgery is to perform EID as soon as possible as long as the patient is stable with only localized peritonitis. The aim is to insert several DPS to achieve complete drainage of perigastric collection. A key point of the procedure is to insert DPS in the most sloped part of collection.

Surgical toilette and drainage of the collection is mandatory when there is general sepsis. In such cases we wait at least one week before performing EID in order to allow the formation of a pseudo-capsule circumscribing the perigastric “third space” and the aim of EID is to insert short DPS in the direction of the surgical drainage in order to invert the flow and induce an internal drainage thus allowing early removal of the surgical drainages. Flow inversion is sped up by drainage removal (usually carried out in our practice one or two days after the surgical procedure). The question could be how many pigtails have to be inserted? Apart from the size of the defect it mainly depends on the size of the cavity that must be internally drained.

In our experience, we delivered between 1 and 5 DPS from 7 to 10 Fr in diameter.  Sometimes dilation of defect was needed as well. According to the size of defect direct endoscopic exploration with lavage, aspiration of pus and necrosectomy was performed if necessary.

We believe that EID has some advantages over the other proposed techniques. Firstly, the negative pressure inside the GI tract (due to the peristaltism) simulate a vacuum system inducing a favourable pressure gradient. Secondly, the drainage is shorter than surgical or radiologic drains. Furthermore, 90% of leaks occur at the proximal margin of the staple line; this location corresponds to an unfavourable pressure gradient for external drainage moreover in such location the omentum promote rapid circumscription of the collection in most cases.

Lastly EID is usually well tolerated by the patient, it reduces the number of required surgery thus greatly reducing overall costs.

Adverse events related to procedure occur in 2% of cases consisting mainly in the following events: migration of the DPS inside the “third space” or in surrounding structures (spleen), bleeding due to ulcer on the distal edge, air embolism (use of CO2 inflation is mandatory), pulmonary embolism and GI perforations during DPS delivery.

In our experience, more than 330 patients were successfully treated by means of EID for leaks following gastric by-pass or sleeve gastrectomy. Clinical success (no sepsis and normal oral diet) was achieved in 91% of patients. All failures (9%), were related to chronic fistula. In 45% of patients EID was performed as first line treatment with no need of surgical nor radiologic drainage. However, 10 % of these patients required, complementary surgical/radiologic drainage. 

Some secondary fistulas were successfully treated by EID as well. In particular some gastro-bronchial fistula was treated with prolonged EID for sub-phrenic collections. It is important to keep in mind that successful management of leaks of the upper gastric staple line following gastric bypass are responsible in 75% of cases in the formation of a secondary sub-clinical gastro-gastric fistula which need no surgical revision except in case of inadequate weight loss or weight regain (Figure 7).

Figure 7: Subclinic gastro-gastric fistula (yellow arrow) following successful management of leaks of the upper gastric staple line following gastric bypass

Key points for the success of EID in the management of leaks are:  early treatment, early removal of surgical drainages and enteral nutrition.

However, EID is not the magic bullet. Pre-operative preparation of patients, strict follow up, improvement of surgical technique, adequate training and reinforcement of the staple line are the fundamental steps to reduce complication rate and leak occurrence.

Finally, a close cooperation between endoscopist, surgeon and radiologist is needed.

Presently, we have enough evidence to suggest that it is important to consider EID early on in the course of management of leak, as it obviates the need of revision surgery in a large population of patients and achieves good success rates with low morbidity and more importantly, reduces occurrences of chronic leaks and/or fistula, the dreadful complications of post-op gastric leaks.

EID could soon become the gold standard endoscopic treatment in the management of such complication.

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