Endoscopic Bariatric Duodenal Jejunal Bypass Liner

Anatomy and Physiology

Anatomy

To perform an endoscopic bariatric procedure, the clinician must have a thorough understanding of the entire intra abdominal cavity. Different organs involved include the esophagus, stomach, and small intestine.

• Esophagus

The esophagus is located posterior to the trachea and begins distal to the cricoid cartilage and ends at the cardiac orifice of the stomach. It ranges in diameter from 4 to 6 mm and in length from 9 to 10 cm in the term infant to approximately 25 cm in the adult. The change in the mucosa color from pale- to reddish-pink marks the transition from the esophagus and gastric epithelium (Z line).

• Stomach

The stomach is a muscular tube that generally makes a “reversed C” contour when viewed from anterior to posterior. It begins at the lower esophageal sphincter and ends as it continues as the first portion of the duodenum. It is divided into the cardia (just distal to GE junction), fundus (abutting the left diaphragm), body, antrum, and pylorus (most distal portion entering the duodenum). The fundus is visible in a retroflexed endoscopic view. The lesser curvature lies beneath the medial segments of the liver and is attached to it via the gastrohepatic ligament (the lesser omentum). Along the lesser curvature of the stomach is the incisura which divides the gastric body from the antrum. Endoscopically, the transition from the body to the antrum is from rugae to flat mucosa. The pylorus is the muscular opening between the lower end of the stomach and the duodenum bulb.

• Duodenum

The duodenum then forms a C-shaped loop and endoscopically turns posteriorly and to the right for 2.5 cm, then inferiorly for 7.5 to 10 cm (descending portion), then anteriorly and to the left for approximately 2.5 cm, and finally connects to the jejunum at the level of ligament of Treitz.

The duodenum is divided into four portions. The duodenum extends from the pylorus to the duodenojejunal angle. The second portion of the duodenum contains the duodenal papilla which is the opening on the medial portion of the duodenum that allows the common bile duct and pancreatic duct to drain into the alimentary tract. The third part of the duodenum is the horizontal and inferior portion (10-12 cm in length) beginning at the inferior duodenal flexure and passes transversely to the left in front of the inferior vena cava, abdominal aorta, and the vertebral column. The fourth portion of the duodenum emerges from the retroperitoneum and traverses the transverse mesocolon at the ligament of Treitz to become the jejunum. Endoscopically the duodenum bulb is an expanded region immediately distal to the pylorus. The duodenum then forms a C-shaped loop and endoscopically turns posteriorly and to the right for 2.5 cm, then inferiorly for 7.5 to 10 cm (descending portion), anteriorly and to the left for approximately 2.5 cm, and finally connects to the jejunum at the level of ligament of Treitz.

• Jejunum

The jejunum lies in the intraperitoneal cavity and transitions into the ileum, which leads to the large intestine at the ileocecal valve. The average small bowel length is approximately 500 cm but can range from as little as 200 cm to about 800 cm.

Pathophysiology

DJBL acts similar to Roux-en-Y Gastric Bypass (RYGB). It causes energy restriction and improves hepatic insulin sensitivity. By achieving weight loss it also improves peripheral insulin sensitivity. There is also an exponential increase in postprandial insulin concentration. These two effects improve the DM-2. Moreover, GLP-1 (Glucagon-like peptide 1), PYY (Peptide YY3–36), and anorexigenic hormones like oxyntomodulin and cholecystokinin induce weight loss and improve insulin sensitivity. Weight loss is also induced by an increase in satiety, a decrease in leptin, and an increase in adiponectin levels. [10] 

Indications

Selection of patient, procedure, and long-term follow-up warrant a multidisciplinary approach according to recent guidelines. For a patient to be a candidate for an endoscopic weight loss procedure, they historically must meet the following criteria as per American Society for Gastrointestinal Endoscopy (ASGE) guidelines:[5] 

1. BMI greater than or equal to 40
2. BMI greater than or equal to 35 with at least one obesity-related comorbid condition (HTN, DM, severely limiting MSK issues)
3. Unsuccessful nonoperative weight loss attempts
4. Mental health clearance
5. No alcohol or substance abuse
6. No medical contraindications to surgery

American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery ofObesity And Metabolic Disorders (IFSO) recommends Metabolic Bariatric Surgery (MBS) for patients with:[11] 

• BMI >35 kg/m² regardless of obesity-associated comorbidities
• BMI of 30–34.9 kg/m² who are unable to achieve remarkable or persistent weight loss or improvement of obesity-associated medical problems using nonsurgical methods

Contraindications

A complete history and physical examination should be completed for all patients to screen for contraindications. The patient's history should focus on any gastrointestinal disorders. Absolute contraindications include any prior gastric surgeries, coagulopathies, severe liver disease, upper gastrointestinal bleeding lesions, pregnancy as well as the desire to become pregnant, alcoholism, drug addiction, and any contraindication for the patient to undergo esophagogastroduodenoscopy (EGD).[12][13]

Equipment

The following types of equipment are required for the procedure

• Endoscope system
• Guidewire
• Fluoroscopy machine
• Duodenal Jejunal Bypass Liner

Types of Duodenal Jejunal Bypass Liner (DJBL)

Three types of DJBL devices are in use [14]

1. DuodenoJejunal Bypass Sleeve (DJBS)
2. Gastroduodenojejunal bypass sleeve (GDJBS)
3. DJBS with flow restrictor

1. Duodenal Jejunal Bypass Sleeve (DJBS)

   The DJBS mimics Roux-en-Y surgery (RYGB). It consists of 2 parts; a metallic anchor (Nitinol) and a 60cm long GI liner. It is implanted in the duodenal bulb and the GI liner is extended to the proximal jejunum.

2. Gastroduodenojejunal bypass sleeve (GDJBS)

   GCJBS extends from the GE junction i.e. more proximally than DJBS to proximal jejunum. It has a long 120cm sleeve.

3. DJBS with flow restrictor

   It is a modification of DJBS. It has a 4mm restrictor distal to anchor to slow gastric emptying.

   The DJBS is the most commonly used bypass liner. The system is delivered into the GI system using an endoscope under fluoroscopic guidance. For GDJBS, a laparoscope is also used for surveillance to avoid visceral injury.[14]

Personnel

Before placing DJBL, the patient must undergo a thorough general physical examination, a detailed history, and consent must be obtained. The patient should be under the care of a multidisciplinary team, including a nutritionist, gastroenterologist, and bariatric surgeon. The nutritionist will help develop a plan for the patient before and after the placement of DJBL. Typically, the gastroenterology team sees the patient for 12 months. For the operative portion, the following personnel are required: an anesthesiologist, an experienced metabolic surgeon, a gastroenterologist, a scrub nurse, and a first assistant.

Preparation

The risks, benefits, and alternatives of the procedure must be explained. The patient must adhere to a clear, liquid diet a few days before the procedure to empty the stomach.[15] The procedure is done as a day case. The patient is required to be nil per os after midnight for the procedure. The choice of anesthesia is continuous sedation (CS) and general anesthesia (GA), with a mean operating room time of 30 minutes to 1 hour, respectively.[14] As prophylaxis, PPIs are used preoperatively and as a continuous infusion during the hospital stay to prevent any gastric irritation and post-procedure GI bleeding. [16]

Morbid obesity in women can have many implications. It can lead to irregular menstrual cycles and infertility. Also, morbidly obese women are at increased risk of developing many obstetric complications, such as gestational diabetes, pregnancy-induced hypertension/preeclampsia, and anesthesia-associated complications. Large gestational age fetuses are more common in morbidly obese women. Many clinical practice guidelines, including guidelines from the American Society for Metabolic & Bariatric Surgery (ASMBS), recommend avoiding pregnancy before and at least 12-18 months after bariatric procedures. The main concern of pregnancy in the immediate early postoperative period after bariatric surgery is the developing fetus could be affected by rapid weight loss and potential micronutrient deficiencies. Rapid weight loss with resulting malnutrition can affect the mother as well. The American College of Obstetricians and Gynecologists (ACOG) recommends using non-oral hormonal contraception (eg, levonorgestrel intrauterine system or implants) for women who undergo bariatric procedures and desire hormonal contraception. Barrier contraception is also helpful in the prevention of sexually transmitted diseases. The physiologic and anatomic changes of bariatric procedures may augment the risk of oral contraceptive failure. Oral contraceptive pills also increase the risk of thromboembolism in obese patients.[17][18][19]

Technique or Treatment

Always ensure strict adherence to inclusion criteria, including BMI requirements and evaluation for esophagitis, gastric polyps, or ulcers which might complicate placement. Given the nature of the device, patients should fully understand potential complications such as device migration or gastrointestinal perforation. It’s crucial to prepare patients with pre-procedure nutritional education as they may face malabsorption and require specific dietary modifications.

Procedure [20][21]

1. DJBS is the most commonly used Duodenal Jejunal Bypass Liner.
2. In the operating room (OR), GA or CS is given to the patient.
3. A standard upper GI endoscope is introduced via the oropharynx, advancing into the stomach and duodenum.
4. Visualization of the esophagus, stomach, and duodenum is done to rule out any pathology that may complicate the procedure.
5. The delivery capsule (17mm) contains a nitinol anchor (53mm) and GI liner (long flexible sleeve).
6. Using the working channel of the endoscope a guide wire is delivered under fluoroscopic guidance.
7. The capsule is delivered with the help of a 1.4m long outer catheter.
8. Anchor is positioned.
9. Under fluoroscopic guidance, the liner is gently deployed starting from the duodenal bulb and extended into the proximal jejunum, ensuring smooth passage to avoid trauma to the intestinal mucosa with the help of a 3m long inner catheter.
10. The placement is confirmed with contrast-enhanced fluoroscopy to ensure the liner extends approximately 60-100 cm into the jejunum. Endoscopic examination confirms correct unfolding and the absence of any twists in the liner.
11. The technique is the same for delivering DJBS with a flow restrictor.
12. While delivering GDJBS, in addition to the above technique laparoscopic guidance is employed for full-thickness suture at the z-line and to avoid any visceral injury.[14]

Complications

Though the procedure is minimally invasive, complications have been reported.

Periprocedural Complications

Periprocedural complications during placement of DJBL are relatively rare, with minimal impact on patient outcome. Periprocedural complications include;

• Anchor-site anomalies like the short duodenal bulb
• Failure of device expansion
• Nausea
• Vomiting
• Non-cardiac chest pain

Periprocedural complications can be managed conservatively by symptomatic relief with antiemetics. Close monitoring for the resolution of symptoms is warranted.[12]

Post Procedural Complication

After successful deployment, patients are monitored for immediate signs of complications such as bleeding or perforation. Post-procedural complications are feared after DJBL and can be divided as minor or major post-procedural complications. Betzel B et al. also published a systemic review based on thirty-eight studies on adverse events in patients in the Netherlands up to 2018. They documented 3.7% severe adverse events. Kral J. et al., documented some post-procedural complications besides the benefits of DJBL in a retrospective data analysis from the USA between 2013 and 2017.[22] 

• Minor Post procedure Complications

Minor post-procedure complications are more common than periprocedural complications but still occur infrequently in the majority of cases. These complications are generally mild to moderate in severity and can often be managed conservatively. Minor procedure complications include;

• Early device extraction
• Leaks
• Nausea (2.48%)
• Vomiting (0.83%)
• Dyspepsia
• Flatulence/Abdominal distension
• Diarrhea/Constipation
• Epigastric/Abdominal pain (3.3%)
• Abdominal discomfort (0.83%)
• Hypoglycemic symptoms
• Fever
• Pseudo polyp
• Esophagitis/gastritis/duodenitis

Management may involve symptomatic treatment with medications such as proton pump inhibitors for dyspepsia or dietary modifications to address flatulence or abdominal distension. Close follow-up is important to monitor the resolution of symptoms and prevent progression to more severe complications. Minor complications can be managed conservatively. [16]

• Major Post procedure Complications

So far, no death has been reported due to any adverse event after the placement of the duodenal jejunal bypass liner.[23] Major postprocedure complications are rare but can have significant implications for patient outcomes. These complications are often more severe and may require hospital admission or endoscopic intervention. These complications often present late, most commonly due to poor device placement. Major procedural complications that require hospital admission or endoscopic intervention, including early implant removal, are:

• Malabsorption/Vitamin or mineral deficiency
• Debilitating pain
• Upper GI bleed/Hematemesis (3.3%)
• Device migration/movement
• Sleeve obstruction (0.83%)
• Acute cholecystitis/cholangitis
• Sleeve migration/occlusion
• Pancreatitis (0.83%)
• Liver abscesses due to potential biliary occlusion (0.83%)

Management of major postprocedure complications may involve interventions such as endoscopic removal of the DJBL device, pharmacological therapy for associated symptoms or complications (e.g., antibiotics for cholecystitis), or surgical intervention in cases of device migration or occlusion.[5]

Adverse events at explant

• Oropharyngeal and esophageal mucosal tear 

Removing the DJBL after 12 months is recommended to avoid these post-procedural complications.[5]

Clinical Significance

DJBL is a novel, important pre-bariatric surgery intervention in patients who are unwilling for MBS, unfit for surgery, or who are high-risk with a "hostile abdomen". In an observational study by Younas et al., 11 high-risk patients with multiple comorbidities were enrolled. All the patients had DJBL implanted, and after 12 months, they underwent a bariatric surgery procedure. The author reported improved glycemic control and weight loss, and improved post-op outcomes in his patients as compared to a cohort of 550 patients who underwent bariatric surgery straightaway.[24] In another study by Kral et. al, a significant decrease in weight (10.3% ± 7.9%), HbA1c (0.5%), and reduction in transaminase and lipid levels were observed in a retrospective cohort of 21 patients.[22] Despite many favorable studies with results showing improved outcomes with DJBL, it is not an alternative for bariatric surgery procedures, and in the long run, surgical procedures are always superior in terms of efficacy and safety. Balint IB et al., reviewed 11 publications on pylorus-preserving bariatric surgery (PPBS) and 6 studies on duodenojejunal bypass liner (DJBL), they have reported equal risk and more complication rate in patients with PPBS.  [25]

As mentioned above, the DJBL has a significant effect on obesity-related issues. These effects are summarized and listed below:[14]

1. Early satiety
2. Weightloss
3. Lowers BMI
4. Improvement in insulin resistance and DM2 control
5. Reduction in TG/HDL ratio

Enhancing Healthcare Team Outcomes

The Endoscopic Bariatric Duodenal Jejunal Bypass Liner represents a significant advancement in non-surgical weight loss interventions, offering obese patients an alternative to traditional bariatric surgery. Successful implementation and management of this procedure require the collaborative effort of an interprofessional healthcare team. Each team member (i.e. bariatric surgeons, gastroenterologists, nurses, dietitians, pharmacists, and other allied health professionals) plays a crucial role in ensuring patient-centered care, optimizing patient outcomes, and enhancing overall team performance.

Each healthcare professional must possess specific skills and knowledge to contribute effectively to patient care. Bariatric surgeons and gastroenterologists must have advanced endoscopic skills to ensure precise device placement, management of potential complications, and eventual device removal. Nurse practitioners and physician assistants, play a key role in pre-procedural assessment, patient education, and follow-up care. Nurses are instrumental in monitoring patients after the procedure, managing immediate care needs, and educating patients on lifestyle modifications. Pharmacists contribute by ensuring the appropriate use of medications to manage side effects and prevent complications. 

The strategic approach to DJBL management involves evidence-based protocols tailored to individual patient needs. Ethical considerations are paramount, particularly in patient selection, where informed consent and patient autonomy must be respected. Ensuring that the patients are fully aware of the benefits, risks, and potential complications is essential for ethical practice. The interprofessional team must work together to create a treatment plan that aligns with the patient’s goals and values, fostering a shared decision-making process. 

Effective interprofessional communication is critical in the management of DJBL patients. Clear, consistent communication among team members allows for seamless information exchange, ensuring that all aspects of patient care are well-coordinated. Regular interdisciplinary meetings or case discussions can be utilized to review patient progress, address any concerns, and adjust treatment plans as necessary. For example, dietitians and nurses must work closely to ensure patients adhere to dietary guidelines, while pharmacists and physicians collaborate to manage medication regimens and monitor for adverse reactions.

Care coordination is another crucial element, particularly given the need for ongoing follow-up and monitoring. The healthcare team must ensure that patients receive continuous care from device placement to removal and beyond. This includes coordinating follow-up appointments, managing complications, and ensuring access to the necessary resources for lifestyle modifications. A well-coordinated care approach reduces the risk of complications, enhances patient safety, and improves overall outcomes. 

Flattening the hierarchy within the healthcare team is a key goal in achieving optimal patient outcomes. Recognizing and valuing the contributions of all team members—regardless of their role—ensures that the patient receives comprehensive, well-rounded care. Encouraging open dialogue and collaboration among all members of the healthcare team fosters an environment where each professional's input is valued, leading to better decision-making and more effective patient care strategies.

Nursing, Allied Health, and Interprofessional Team Interventions

After placing a DJBL, nutritional support, and guidance are vital for optimizing patient outcomes and ensuring long-term success. Evidence suggests several key considerations for nutritional support after DJBL placement.

1. Post-Placement Diet Progression: Patients gradually transition from clear liquids to full liquids and eventually to a solid food diet over several weeks following DJBL placement. This progression helps the gastrointestinal tract adapt to the presence of the device and minimizes the risk of complications.[27]

2. Balanced Macronutrient Intake: A balanced intake of macronutrients is crucial for maintaining overall health and supporting weight loss after DJBL placement. Incorporating sources of lean protein, healthy fats, and complex carbohydrates into the diet can provide essential nutrients while promoting satiety and weight loss. [28]

3. Fiber-Rich Foods: Fiber-rich foods such as fruits, vegetables, whole grains, and legumes play a crucial role in promoting digestive health and preventing constipation after DJBL placement. Fiber can also help slow down digestion and improve nutrient absorption in the lower intestine, compensating for the partial bypass of the upper intestine.[29]

4. Supplementation: Given the potential for malabsorption after DJBL placement, supplementation with vitamins and minerals may be necessary to prevent nutrient deficiencies. Regular monitoring of nutrient levels through blood tests is essential for identifying and addressing deficiencies promptly.[30]

5. Hydration: Adequate hydration is essential for overall health and digestion, particularly after DJBL placement. Patients should aim to drink plenty of water throughout the day to prevent dehydration and facilitate digestion.[31]

6. Portion Control and Mindful Eating: Since the DJBL promotes early satiety and reduces stomach capacity, patients should practice portion control and mindful eating habits to avoid overeating. Eating slowly, chewing food thoroughly, and paying attention to hunger and fullness cues can help prevent discomfort and promote weight loss.[32]

7. Regular Follow-Up and Monitoring: Close follow-up with healthcare providers, including bariatric surgeons and registered dietitians, is essential after DJBL placement. Regular monitoring of progress, addressing concerns, and adjusting the diet and treatment plan as needed can optimize outcomes.[33]