Per Oral Endoscopic PyloromyotomyImag (POP) Surgery, GPOEM, and ERCP

I have had this subject saved to write about since March of this year. Life has just gotten in the way, so I've been unable to complete the article like I wanted to. However, I wanted to do some research today on the subject, now that I have had friends who have had it done.  I want to talk about the
Per oral endoscopic pyloromyotomy (hereto referred as the POP procedure and GPOEM) and ERCP.  I will discuss and share my research about the POP procedure first, but I have written about it in the past. You can find the article I have written on POP/GPOEM here: https://www.emilysstomach.com/2017/06/gpoem-what-is-it-and-how-does-it-help.html

Image Source: The Cleveland Clinic

I found an article that The Cleveland Clinic published in August,

"Innovative Endoscopy Procedure for Gastroparesis Is Safe and Feasible


Gastroparesis, delayed gastric emptying in the absence of mechanical obstruction, is a debilitating and chronic digestive disease affecting 5 million people in the U.S. Typically, medical therapies, intrapyloric injections of botulinum toxin, gastric electrical stimulation therapy and surgical open or laparoscopic pyloroplasty are utilized to manage the disease.

Still, it is a frustrating condition for patients and physicians alike, and until recently these medical and surgical procedures have been largely unsuccessful in resolving the disease’s symptoms or have been associated with complications. According to Cleveland Clinic general surgeon John H. Rodriguez, MD, however, a new, minimally invasive endoscopy therapy, per oral endoscopic pyloromyotomy (POP), has recently shown great promise as an alternative to surgical pyloroplasty for these patients.

Dr. Rodriguez explains that POP has been described in small case reports since 2013 and was first performed at Cleveland Clinic in January 2016. Since that time, he and his colleagues have conducted a prospective study of the technique, and recently published results in Surgical Endoscopy on the first 47 subjects (although to date they have performed almost 100 cases).
The POP study design

From January 2016 to January 2017, prospective patients who were suspected of having gastroparesis were evaluated by a multidisciplinary team comprised of a psychiatrist, dietitian, gastroenterologist and four surgeons specializing in minimally invasive techniques. Prior to having the procedure, a four-hour, non-extrapolated gastric-emptying scintigraphy study was performed on all subjects, who subjectively rated their symptoms on the Gastroparesis Cardinal Symptom Index (GCSI). Subjects repeated the GCSI at three months after POP.

Of the 47 patients, 27 (57.4 percent) were classified as having idiopathic gastroparesis, 12 (25.6 percent) as having diabetic gastroparesis and eight (17 percent) as having postsurgical gastroparesis. The majority of the patients (87.2 percent) had been treated with one or more previous interventions for their symptoms, such as placement of an enteral feeding tube or a gastric pacer or botulinum toxin injection.

Image Source: HERE. Per-oral pyloromyotomy is a minimally invasive, lower-risk method of disrupting the pylorus that has been shown to improve gastroparesis symptoms.

The POP procedure was performed in the operating room under general anesthesia. Patients stayed in the hospital overnight after the POP procedure and an upper gastrointestinal (GI) series was performed to assess emptying through the pylorus and to check for unrecognized perforations. At discharge, patients were instructed to follow a liquid diet for two weeks and to take anti-acid therapies (sucralfate and a proton pump inhibitor) for four weeks. A repeat gastric-emptying study was performed at three months post-procedure.

The POP procedure produced statistically significant objective and subjective improvements in gastroparesis symptoms at 30 days and three months after treatment. Prior to the procedure, the average percentage of retained food at four hours was 37 percent and the average GCSI score was 4.6. After POP, the retained food percentage was reduced to 20 percent and the GCSI score to 3.3.

One patient died within 30 days of the POP procedure, but his death was unrelated to the surgery. “The procedure is very safe,” says Dr. Rodriguez, “and there were no procedure-related adverse events, including gastric or duodenal ulcer, intraluminal hemorrhage or gastric dumping syndrome.” There were also no repeat surgeries or hospitalizations related to the POP procedure.
A first-line treatment option

“This procedure has dramatically changed our practice at the Cleveland Clinic, and has become our first-line treatment option for medically refractive gastroparesis in well-selected patients,” Dr. Rodriguez says.

According to Matthew D. Kroh, MD, head of the research group and Chief of the Digestive Disease Institute at Cleveland Clinic Abu Dhabi, “POP is an attractive option for patients who in the past would have been offered surgical therapy because it is less invasive. This endoscopic procedure results that are similar to the best alternatives, without the morbidity associated with surgical access, and has a short recovery time.” Dr. Rodriguez adds that “because of its safety profile, we are able to apply POP more broadly than we could apply surgical interventions.”

Dr. Rodriguez reports that Cleveland Clinic has taken the lead in the U.S. with the POP procedure, but because GI motility is so complex and gastroparesis fairly common, he expects to see the technique become more widespread as more experience aggregates on its long-term safety and effectiveness."

According to Sages,

"Early human experience with Per-Oral Endoscopic Pyloromyotomy (POP)

Eran Shlomovitz, MD, Radu Pescarus, MD, Ahmed Sharata, MD, Kevin M Reavis, MD, Christy M Dunst, MD, Lee L Swanstrom, MD. Providence Portland Medical Center, The Oregon Clinic..



Introduction:
Gastroparesis, a condition characterized by delayed gastric emptying, and a constellation of symptoms including nausea, vomiting, early satiety and bloating, is a debilitating condition. A variety of surgical options are available including pyloroplasty and pyloromyotomy. Although these have been shown to be effective they are associated with surgical trauma. We hypothesize that an endoscopic submucosal myotomy technique can be applied to endoscopically divide the pyloric sphincter, provide the benefits of a natural orifice procedure and improve gastric emptying in gastroparetic patients.


Methods and procedures:
Endoscopic per-oral pyloromyotomy (POP) was performed in four female patients ages 65, 59, 33 and 32 years old. All patient underwent a complete pre-operative work-up including upper endoscopy, gastric emptying study as well as a pH study and esophageal manometry if a concomitant fundoplication was performed. Three procedures were performed under laparoscopic guidance as patients required other concurrent laparoscopic procedures (see table). In one patient the procedure was fully endoscopic. The myotomy was performed by a technique similar to the one utilized in the POEM procedure. After the creation of a mucosotomy, a submucosal tunnel is established up to the duodenal bulb followed by a myotomy of the circular fibers of the pylorus. The mucosotomy is subsequently closed with clips.


Results:
Endoscopic per-oral pyloromyotomy was technically successful in all four cases and patients were discharged home on post operative day 2 or 3. There were no immediate procedural complications. One patient presented to the hospital 2 weeks post procedure with an upper GI bleed necessitating transfusions. On endoscopy a 1cm ulcer was found in the pyloric channel and an exposed vessel was clipped. The patient was subsequently discharged home on high dose proton pump inhibitors. Three month follow-up nuclear medicine gastric emptying studies (GES) are available for 3 of the 4 patients. Normalization of gastric emptying studies was demonstrated in 2 patients. Patient 3 showed improved gastric emptying half life, but unchanged residual activity at 4hrs.

	Concomitant procedure	Operative time	Blood loss	Pre-op GES	Post-op GES
Patient 1 65 F	Cholecystectomy	102 min	Minimal	Half life: 150min Residual at 4hrs: 29%	Half life: 36min Residual at 4hrs: 0%
Patient 2 59 F	Redo- PEH repair and Nissen	295 min	100 cc	Half life: 90min Residual at 4hrs: 14%	Half life: 18min Residual at 4hrs: 0%
Patient 3 33 F	Nissen	231 min	Minimal	Half life: 160-170min Residual at 4hrs: 15%	Half life: 70-90min Residual at 4hrs: 14%

Conclusion:
Endoscopic pyloromyotomy is a technically feasible and potentially much less morbid endoscopic surgical procedure. Early follow-up suggests objective improvement in gastric emptying. Further long-term follow-up and additional clinical experience is required to establish the role of this technique in the management of gastroparesis."

 Image Source: The Cleveland Clinic

ERCP

Now, I want to discuss ERCP.  I have had this procedure done to me, personally, and it helped me a great deal.  I had my ERCP done in 2012, when I was first diagnosed with Gastroparesis.  The doctors had to place a stent in my bile duct of my liver because it was not draining bile properly. You can read more about my personal experiences in my earlier blog articles:

https://www.emilysstomach.com/2012/08/surgery-today.html

https://www.emilysstomach.com/2012/08/post-surgery.html

https://www.emilysstomach.com/2012/08/day-6-day-after-surgery-oxygen-issues.html

I did develop pancreatitis after the procedure, which can be a side effect.  That was a very painful experience.   However, I want to research ERCP for those of you whose doctors may have suggested it, for those of you curious about it, and for those of you who might not know about the procedure itself.

There is a wonderful video with an explanation of the procedure made by Sages,

This talk was presented at the 2018 SAGES Meeting/16th World Congress of Endoscopic Surgery by Heidi J Miller during the When Bad Things Happen to Good People – Endoscopy: Being FLEXible on April 14 2018

According to the National Institute of Diabetes and Digestive and Kidney Diseases,

"Endoscopic Retrograde Cholangiopancreatography (ERCP)

What is ERCP?

Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that combines upper gastrointestinal (GI) endoscopy and x-rays to treat problems of the bile and pancreatic ducts.

What are the bile and pancreatic ducts?

Your bile ducts are tubes that carry bile from your liver to your gallbladder and duodenum. Your pancreatic ducts are tubes that carry pancreatic juice from your pancreas to your duodenum. Small pancreatic ducts empty into the main pancreatic duct. Your common bile duct and main pancreatic duct join before emptying into your duodenum.

 

 

 Why do doctors use ERCP?

Doctors use ERCP to treat problems of the bile and pancreatic ducts. Doctors also use ERCP to diagnose problems of the bile and pancreatic ducts if they expect to treat problems during the procedure. For diagnosis alone, doctors may use noninvasive tests—tests that do not physically enter the body—instead of ERCP. Noninvasive tests such as magnetic resonance cholangiopancreatography (MRCP)—a type of magnetic resonance imaging (MRI) —are safer and can also diagnose many problems of the bile and pancreatic ducts.
Doctors perform ERCP when your bile or pancreatic ducts have become narrowed or blocked because of

• gallstones that form in your gallbladder and become stuck in your common bile duct
• infection
• acute pancreatitis
• chronic pancreatitis
• trauma or surgical complications in your bile or pancreatic ducts
• pancreatic pseudocysts
• tumors or cancers of the bile ducts
• tumors or cancers of the pancreas
•  

How do I prepare for ERCP?

To prepare for ERCP, talk with your doctor, arrange for a ride home, and follow your doctor’s instructions.

Talk with your doctor

You should talk with your doctor about any allergies and medical conditions you have and all prescribed and over-the-counter medicines, vitamins, and supplements you take, including

• arthritis medicines
• aspirin or medicines that contain aspirin
• blood thinners
• blood pressure medicines
• diabetes medicines
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen

Your doctor may ask you to temporarily stop taking medicines that affect blood clotting or interact with sedatives. You typically receive sedatives during ERCP to help you relax and stay comfortable.
Tell your doctor if you are, or may be, pregnant. If you are pregnant and need ERCP to treat a problem, the doctor performing the procedure may make changes to protect the fetus from x-rays. Research has found that ERCP is generally safe during pregnancy.¹

Arrange for a ride home

For safety reasons, you can’t drive for 24 hours after ERCP, as the sedatives or anesthesia used during the procedure needs time to wear off. You will need to make plans for getting a ride home after ERCP.

Don’t eat, drink, smoke, or chew gum

To see your upper GI tract clearly, you doctor will most likely ask you not to eat, drink, smoke, or chew gum during the 8 hours before ERCP.

How do doctors perform ERCP?

Doctors who have specialized training in ERCP perform this procedure at a hospital or an outpatient center. An intravenous (IV) needle will be placed in your arm to provide a sedative. Sedatives help you stay relaxed and comfortable during the procedure. A health care professional will give you a liquid anesthetic to gargle or will spray anesthetic on the back of your throat. The anesthetic numbs your throat and helps prevent gagging during the procedure. The health care staff will monitor your vital signs and keep you as comfortable as possible. In some cases, you may receive general anesthesia.
You’ll be asked to lie on an examination table. The doctor will carefully feed the endoscope down your esophagus, through your stomach, and into your duodenum. A small camera mounted on the endoscope will send a video image to a monitor. The endoscope pumps air into your stomach and duodenum, making them easier to see.
During ERCP, the doctor

• locates the opening where the bile and pancreatic ducts empty into the duodenum
• slides a thin, flexible tube called a catheter through the endoscope and into the ducts
• injects a special dye, also called contrast medium, into the ducts through the catheter to make the ducts more visible on x-rays
• uses a type of x-ray imaging, called fluoroscopy, to examine the ducts and look for narrowed areas or blockages

The doctor may pass tiny tools through the endoscope to

• open blocked or narrowed ducts.
• break up or remove stones.
• perform a biopsy or remove tumors in the ducts.
• insert stents—tiny tubes that a doctor leaves in narrowed ducts to hold them open. A doctor may also insert temporary stents to stop bile leaks that can occur after gallbladder surgery.

The procedure most often takes between 1 and 2 hours.

What should I expect after ERCP?

After ERCP, you can expect the following:

• You will most often stay at the hospital or outpatient center for 1 to 2 hours after the procedure so the sedation or anesthesia can wear off. In some cases, you may need to stay overnight in the hospital after ERCP.
• You may have bloating or nausea for a short time after the procedure.
• You may have a sore throat for 1 to 2 days.
• You can go back to a normal diet once your swallowing has returned to normal.
• You should rest at home for the remainder of the day.

Following the procedure, you—or a friend or family member who is with you if you’re still groggy—will receive instructions on how to care for yourself after the procedure. You should follow all instructions.

You will receive instructions on how to care for yourself after ERCP. You should follow all instructions.

Some results from ERCP are available right away after the procedure. After the sedative has worn off, the doctor will share results with you or, if you choose, with your friend or family member.
If the doctor performed a biopsy, a pathologist will examine the biopsy tissue. Biopsy results take a few days or longer to come back.

What are the risks of ERCP?

The risks of ERCP include complications such as the following:

• pancreatitis
• infection of the bile ducts or gallbladder
• excessive bleeding, called hemorrhage
• an abnormal reaction to the sedative, including respiratory or cardiac problems
• perforation in the bile or pancreatic ducts, or in the duodenum near the opening where the bile and pancreatic ducts empty into it
• tissue damage from x-ray exposure
• death, although this complication is rare

Research has found that these complications occur in about 5 to 10 percent of ERCP procedures.² People with complications often need treatment at a hospital.

Seek care right away

If you have any of the following symptoms after ERCP, seek medical attention right away:

• bloody or black, tar-colored stool
• chest pain
• fever
• pain in your abdomen that gets worse
• problems breathing
• problems swallowing or throat pain that gets worse
• vomiting—particularly if your vomit is bloody or looks like coffee grounds

 

References

ERCP is a procedure that enables your physician to examine the pancreatic and bile ducts. A bendable, lighted tube (endoscope) about the thickness of your index finger is placed through your mouth and into your stomach and first part of the small intestine (duodenum). In the duodenum a small opening is identified (ampulla) and a small plastic tube (cannula) is passed through the endoscope and into this opening. Dye (contrast material) is injected and X-rays are taken to study the ducts of the pancreas and liver.

 Sages explains ERCP further with images below,

About ERCP

Why is an ERCP Performed?

ERCP is most commonly performed to diagnose conditions of the pancreas or bile ducts, and is also used to treat those conditions. It is used to evaluate symptoms suggestive of disease in these organs, or to further clarify abnormal results from blood tests or imaging tests such as ultrasound or CT scan. The most common reasons to do ERCP include abdominal pain, weight loss, jaundice (yellowing of the skin), or an ultrasound or CT scan that shows stones or a mass in these organs.

ERCP may be used before or after gallbladder surgery to assist in the performance of that operation. Bile duct stones can be diagnosed and removed with an ERCP. Tumors, both cancerous and noncancerous, can be diagnosed and then treated with indwelling plastic tubes that are used to bypass a blockage of the bile duct. Complications from gallbladder surgery can also sometimes be diagnosed and treated with ERCP.

In patients with suspected or known pancreatic disease, ERCP will help determine the need for surgery or the best type of surgical procedure to be performed. Occasionally, pancreatic stones can be removed by ERCP.

Before the Procedure

What Preparation is Required?

Your stomach must be empty, so you should not eat or drink anything for approximately 8 hours before the examination. Your physician will be more specific about the time to begin fasting depending on the time of day that your test is scheduled.

Your current medications may need to be adjusted or avoided. Most medications can be continued as usual. Medication use such as aspirin, Vitamin E, non-steroidal anti-inflammatories, blood thinners and insulin should be discussed with your physician prior to the examination as well as any other medication you might be taking. It is therefore best to inform your physician of any allergies to medications, iodine, or shellfish. It is essential that you alert your physician if you require antibiotics prior to undergoing dental procedures, since you may also require antibiotics prior to ERCP.

Also, if you have any major diseases, such as heart or lung disease that may require special attention during the procedure, discuss this with your physician.
To make the examination comfortable, you will be sedated during the procedure, and, therefore, you will need someone to drive you home afterward. Sedatives will affect your judgment and reflexes for the rest of the day, so you should not drive or operate machinery until the next day.

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

What Can Be Expected During the ERCP?

Your throat will be sprayed with a local anesthetic before the test begins to numb your throat and prevent gagging. You will be given medication intravenously to help you relax during the examination. While you are lying in a comfortable position on an X-ray table, an endoscope will be gently passed through your mouth, down your esophagus, and into your stomach and duodenum. The procedure usually lasts about an hour, but this may vary depending on the planned intervention. The endoscope does not interfere with your breathing. Most patients fall asleep during the procedure or find it only slightly uncomfortable. You may feel temporarily bloated during and after the procedure due to the air used to inflate the duodenum. As X-ray contrast material is injected into the pancreatic or bile ducts, you may feel some minor discomfort.

After the Procedure

What Happens after ERCP?

You will be monitored in the endoscopy area for 1-2 hours until the effects of the sedatives have worn off. Your throat may be sore for a day or two. You will be able to resume your diet and take your routine medication after you leave the endoscopy area, unless otherwise instructed.

Your physician will usually inform you of your test results on the day of the procedure. Biopsy results take several days to return, and you should make arrangements with your physician to get these results. The effects of sedation may make you forget what you were instructed to do after the procedure. Call your surgeon’s office for the results or any further questions.

Expected Outcomes

What Complications Can Occur?

ERCP is safe when performed by physicians who have had specific training and are experienced in this specialized endoscopic procedure. Complications are rare, however, they can occur. Pancreatitis due to irritation of the pancreatic duct by the X-ray contrast material or cannula is the most common complication. A reaction to the sedatives can occur. Irritation to the vein in which medications were given is uncommon, but may cause a tender lump lasting days to a few weeks. Warm moist towels will help relieve this discomfort.

If your ERCP included a therapeutic procedure such as removal of stones or placement of a stent (drain), there are additional small risks of bleeding or perforation (making a hole in the intestine or bile duct). Blood transfusions are rarely required. It is important for you to recognize the early signs of possible complications and to contact your physician if you notice symptoms of severe abdominal pain, fever, chills, vomiting, or rectal bleeding.

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This brochure is not intended to take the place of a discussion with your surgeon about your need for an ERCP. If you have any questions about your need for an ERCP, alternative tests, billing and insurance coverage, or your surgeons training and experience, do not hesitate to ask your surgeon or his/her office staff about it. If you have questions about the exam or subsequent follow-up, please discuss them with your surgeon before or after the examination.

Some images courtesy of Amy Cha,MD; Penn PresbyterianMedical Center, Philadelphia, PA

[1] ASGE Standard of Practice Committee, Shergill AK, Ben-Menachem T, et al. Guidelines for endoscopy in pregnant and lactating women. Gastrointestinal Endoscopy. 2012;76(1):18–24.

[2] Szary NM, Al-Kawas FH. Complications of endoscopic retrograde cholangiopancreatography: how to avoid and manage them. Gastroenterology and Hepatology. 2013;9(8):496–504."

 Image Source: HERE

As always, please discuss these procedures with your doctors. This is just research I have compiled but it does not take the place of a doctor's expertise or advice. 

According to the American Gastroenterological Association,

• "ERCP stands for:
  • Endoscopic — Refers to a tool called an endoscope, a long, thin (about the width of your little finger), flexible tube with a camera on the end. 
  • Retrograde — Refers to the direction (backward) in which the endoscope injects a liquid for X-rays of parts of the GI tract called the bile duct system and pancreas.
  • Cholangio — Refers to the bile duct system.
  • Pancreatography — Refers to the pancreas.
    • The process of taking these X-rays is known as cholangiopancreatography. 

• ERCP can help find the cause of jaundice (when your skin and/or the whites of your eyes turn yellow) or pancreatitis, which is inflammation (swelling and redness) of the pancreas that is often caused by gallstones or alcohol abuse. ERCP can also treat some of those issues.
• Using tools passed through the endoscopic tube, your doctor can inject dye to light up organs under X-rays. This provides a clear view of your pancreas, pancreatic duct, bile duct system, gallbladder and duodenum (the first portion of the small intestine).

ERCP is an endoscopic procedure used to inject dye into the bile and pancreas ducts. X-ray pictures are then taken.

• ERCP can see if there is a blockage or narrowing in your biliary or pancreatic ducts caused by stones, tumors or scarring.
• ERCP is frequently performed to find the cause of abnormal liver-chemistry tests and to follow up on an abnormal ultrasound, CT scan or MRI exam.
• During an ERCP, if any blocks are found, tools can be passed through to relieve the block. Stones can be removed from the common bile duct or pancreatic duct and blocks can be dilated, biopsied and/or stented.
• ERCP can relieve jaundice (when your skin and/or the whites of your eyes turn yellow) caused by blocked bile ducts.
• ERCP can help find the cause of pancreatitis, inflammation (swelling and redness) of the pancreas, and prevent future attacks.
• ERCP may help you avoid surgery in some cases."