Method for frame drainage of stricture of terminal part of pancreatic duct
A two-stage percutaneous drainage method using separate access points for pancreatic ducts addresses limitations of existing methods by achieving safe and effective duct expansion to 19F, reducing complications and ensuring adequate decompression of intraductal hypertension.
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- FEDERALNOE GOSUDARSTVENNOE BYUDZHETNOE OBRAZOVATELNOE UCHREZHDENIE VYSSHEGO OBRAZOVANIYA SANKT PETERBURGSKIJ GOSUDARSTVENNYJ PEDIATRICHESKIJ MEDITSINSKIJ UNIV MINISTSTVA ZDRAVOOKHRANENIYA ROSSIJSKOJ FEDERATSII FGBOU VO SPBGPMU MINZDRAVA ROSSII
- Filing Date
- 2025-05-20
- Publication Date
- 2026-06-30
AI Technical Summary
Existing surgical, endoscopic, and percutaneous methods for treating intraductal pancreatic hypertension due to pancreatic duct strictures suffer from complications such as anastomotic failure, reflux, limited stent diameters, and the risk of external pancreatic fistula, particularly in cases of rigid strictures.
A two-stage percutaneous external-internal drainage method involving separate access points for installing two frame drains, one at the body-tail junction and another 2-3 cm proximal to the head, allowing for a combined duct diameter expansion up to 19F, minimizing damage and reducing fistula risk.
Effectively expands the pancreatic duct diameter to 19F, reducing complications like anastomotic failure and fistula formation, enabling safe and effective decompression of intraductal hypertension without the need for repeated hospital visits.
Abstract
Description
[0001] The invention relates to medicine, specifically to interventional minimally invasive pancreatic surgery. It is used for intraductal pancreatic hypertension resulting from stricture of the terminal pancreatic duct (PD) due to complicated chronic pancreatitis.
[0002] For stricture of the terminal part of the pancreatic duct, several types of surgical interventions are known using traditional, laparoscopic, endoscopic and percutaneous methods.
[0003] Traditional surgical interventions, like laparoscopic ones, are aimed at creating pancreaticodigestive anastomoses, i.e., a bypass for pancreatic juice to enter the small intestine. Currently, surgical treatment shows the best long-term results: 65% of patients report complete pain relief after surgery. Clinical guidelines from the American Society of Gastrointestinal Endoscopy recommend surgical treatment as the first stage of treatment for all patients [1].
[0004] However, modern surgical methods have significant disadvantages:
[0005] 1) Pancreaticodigestive anastomosis operations are traumatic reconstructive interventions that often cause complications, the most serious of which is anastomotic failure and, as a consequence, peritonitis or intraperitoneal abscess;
[0006] 2) When a pancreaticodigestive anastomosis is formed, pancreatic juice enters the lumen of the jejunum through an unnatural pathway, which significantly complicates digestion;
[0007] 3) Constant reflux of intestinal contents into the lumen of the pancreatic ducts is the cause of their frequent inflammation;
[0008] 4) The pancreaticodigestive anastomosis is formed on an isolated loop of the jejunum, which implies the formation of an interintestinal anastomosis to ensure the evacuation of food masses from the duodenum, and, as a result, creates another probable cause of anastomotic failure in complicated cases.
[0009] Since the beginning of the 20th century, a method of endoscopic retrograde drainage of the pancreatic ducts through the major or minor duodenal papillae has been proposed [2]. Today, endoscopic retrograde techniques for decompression of the main pancreatic duct are the gold standard and first line of invasive treatment.
[0010] Endoscopic stenting of the pancreatic duct structure also has a number of disadvantages:
[0011] 1) Difficult selective cannulation of the orifice of the pancreatic duct;
[0012] 2) Often, it is impossible to recanalize the structure of the pancreatic duct retrogradely;
[0013] 3) Long distance from the surgeon's hands to the mouth of the pancreatic ducts (main and accessory), taking into account the length of the endoscope;
[0014] 4) The installed stents have a diameter limit of up to 8-10F, which does not allow for adequate decompression of the pancreatic duct in case of intraductal pancreatic hypertension;
[0015] 5) If it is necessary to sanitize the stent lumen, endoscopic technique and anesthesia are required, which precludes the procedure from being performed on an outpatient basis;
[0016] 6) The lumen of the plastic stent is inlaid every 2-3 months, which is the reason for the frequent replacement of the latter in a hospital setting under anesthesia.
[0017] Percutaneous drainage of the main pancreatic duct under ultrasound guidance is a highly accessible therapeutic procedure. Despite all the advantages of external-internal drainage of the pancreatic duct for strictures and intraductal pancreatic hypertension, there is one drawback that cannot be eliminated with a single-access percutaneous approach. With a single approach to the pancreatic duct, the external-internal drains used have a diameter limit of up to 12-14F. In some situations, namely with rigid strictures, the predicted recurrence of which is likely after removal of the external-internal drain associated with a natural decrease in the connective tissue framework by 30-50% after drainage, dilation of the terminal section of the pancreatic duct to 16-20F is indicated. Performing a frame drainage of the pancreatic duct through a single approach is not possible for several reasons:
[0018] 1) There are no standard frame drains with a diameter larger than 14F;
[0019] 2) Carrying out 2 drains through a single percutaneous access along the entire length of the pancreatic duct to the terminal section of the pancreatic duct, i.e. to the structure area, is not advisable, due to the lack of need for frame drainage of the pancreatic duct in the body area that is not altered by the cicatricial structure;
[0020] 3) Wide-bore single access to the pancreatic duct after removal of the drainage or drainages is often the cause of the formation of an external pancreatic fistula.
[0021] The closest method to the claimed one is percutaneous antegrade external-internal drainage of the accessory (Santorini) or main pancreatic (Wirsung) duct [3]. Percutaneous puncture and external-internal antegrade drainage of the pancreatic or accessory pancreatic duct are performed under ultrasound and X-ray control.
[0022] The disadvantage of the method chosen as prototype, is that with this drainage option, in the case of a resistant rigid stricture of one of the pancreatic ducts, it is technically impossible to perform drainage using drains with a diameter greater than 10F.
[0023] The objective of the invention is to ensure effective external-internal drainage of the pancreas in case of rigid strictures of one of the pancreatic ducts.
[0024] The technical result of the set task is achieved by the fact that in the method of frame drainage of the stricture of the terminal section of the main pancreatic duct (MPD) of the pancreas (PG), characterized by the fact that percutaneous drainage of the MPD of the PG is performed, the first stage is the percutaneous installation of a frame external-internal drainage in the lumen of the MPD of the PG at the border of the body and tail of the PG, after which, after 3 weeks, with adequate decompression of intraductal pancreatic hypertension, in the second stage, through an access 2-3 cm proximal to the previous access, a percutaneous installation of a second frame external-internal drainage is performed at the border of the body and head of the PG.
[0025] Double frame drainage of the stricture of the terminal part of the pancreatic duct through separate percutaneous approaches allows for effective expansion of the pancreatic duct in the area of the stricture without damaging the access to the duct.
[0026] After placement of the first external-internal drain to decompress intraductal pancreatic hypertension and ensure internal drainage of the pancreatic duct, 2-3 weeks are required for the formation of a connective tissue framework around the drain, isolated from the free abdominal cavity. The main purpose of the formed channel around the drain from the pancreatic duct to the skin is to isolate the drain and prevent possible leakage of pancreatic juice into the free abdominal cavity. Furthermore, during further manipulations of the pancreatic duct, the presence of a formed isolated channel prevents the unintended migration of manipulators and guidewires.After 3 weeks, with the isolated channel formed and adequate decompression of the pancreatic duct, puncture of the pancreatic duct at another point is safe due to the absence of the risk of pancreatic juice leakage into the free abdominal cavity due to the absence of hypertension inside the pancreatic duct, thanks to the previously installed frame external-internal drainage.
[0027] The first frame-based external-internal drainage system provides adequate decompression and internal drainage of the pancreatic duct in patients with intraductal pancreatic hypertension due to the structure of the terminal duct. In certain conditions, frame-based drainage, namely in patients with a rigid structure and a high risk of recurrence after removal of the frame-based external-internal drainage system, is indicated. A greater expansion of the duct diameter in the stricture area is recommended to ensure adequate diameter reserve for the formed frame, given the inevitable decrease in pancreatic duct diameter after frame removal.
[0028] The second frame drain is placed solely to increase the diameter of the frame in the area of the structure, as the first external-internal drain provides decompression of intraductal pancreatic hypertension. The second external-internal frame drain is placed as close as possible to the pancreatic duct structure, typically 2-3 cm proximal to the first frame drain.
[0029] Thus, recanalization of the stricture of the terminal part of the MPD is achieved through two separate approaches; the diameter of the dilated duct in the stricture area is about 19F.
[0030] The method is as follows.
[0031] The first step is to access the pancreatic duct by percutaneous puncture of the pancreatic duct at the junction of the body and tail of the pancreas through the epigastric approach along the left parasternal line using a 21" Chiba needle. After visualizing the needle tip in the pancreatic duct using ultrasound, the lumen of the duct is contrasted using a water-soluble contrast agent. A Cope guidewire is then advanced into the lumen of the pancreatic duct, and a Neff complex is installed along the guidewire.
[0032] We pass a hydrophilic guidewire through the external catheter into the lumen of the pancreatic duct. Using a manipulation catheter, we advance the guidewire into the lumen of the duodenum, after which we exchange the guidewire for a rigid one. We insert a 10.2F diameter external-internal drainage system with a locking device over the rigid guidewire. The drainage is secured in place.
[0033] After 3 weeks, with the isolated channel formed and adequate decompression of the pancreatic duct, puncture of the pancreatic duct at another point is safe due to the absence of the risk of pancreatic juice leakage into the free abdominal cavity due to the absence of hypertension inside the pancreatic duct, thanks to the previously installed frame external-internal drainage.
[0034] After 3 weeks, the second stage involves performing an extraorgan puncture of the previously drained pancreatic duct at the junction of the body and head of the pancreas, 2-3 cm proximal to the previous access, through an epigastric approach along the right parasternal line, as close as possible to the stricture of the terminal section of the duct. A Cope guidewire is then advanced into the lumen of the pancreatic duct; a Neff complex is installed along the guidewire. A hydrophilic guidewire is advanced through the external catheter into the lumen of the pancreatic duct. Using a manipulation catheter, the guidewire is advanced into the lumen of the duodenum next to the previously installed external-internal drainage. The guidewire is replaced with a rigid one. An external-internal drainage with a lock, diameter 8.5F, is installed along the rigid guidewire next to the previously installed external-internal drainage, diameter 10.2F.
[0035] The second frame external-internal drainage is installed as close as possible to the area of the pancreatic duct structure, this is, as a rule, at a distance of 2-3 cm proximal to the installed first frame drainage.
[0036] Thus, recanalization of the stricture of the terminal part of the MPD is achieved through two separate approaches; the diameter of the dilated duct in the stricture area is about 19F.
[0037] Example.
[0038] Patient N., 67 years old, was admitted to the Mariinsky City Hospital in St. Petersburg on February 28, 2025, with complaints of nausea, vomiting, and a febrile fever up to 38.5°C. His medical history indicates that he has considered himself ill since April 2023, when he was hospitalized with similar complaints at the Mariinsky City Hospital, where an examination diagnosed chronic calculous pancreatitis. Between April 2023 and September 2023, multiple punctures and external-internal drainage of the MPD were performed.
[0039] Upon admission, laboratory tests revealed elevated serum amylase to 657 U / L and C-reactive protein to 57 g / L. The patient was examined in the emergency room and diagnosed with chronic pancreatitis. Pancreaticolithiasis. Terminal pancreatic duct stricture. Intraductal pancreatic hypertension.
[0040] The procedure was performed under intravenous anesthesia using the recommended method. When contrasted, the contrast material flows freely into the duodenum, with no leakage. The diameter of the dilated duct in the papilla area is approximately 19F. Drains are secured. An aseptic dressing is applied.
[0041] The postoperative period was uneventful. On the first postoperative day, serum amylase decreased to 162 U / L, and on the seventh day, it decreased to 63 U / L. The patient was discharged in satisfactory condition on the seventh postoperative day.
[0042] Advantages of the claimed method:
[0043] 1) The installation of 2 frame drains in the area of the pancreatic duct stricture allows for more effective expansion of the pancreatic duct in the area of the stricture without damaging the access to the duct, given the small diameters of two separate frame drains inserted into the duct through different accesses;
[0044] 2) This method allows to bypass the limitation of the method associated with the diameter of the external-internal drains used for adequate decompression;
[0045] 3) When using separate minimal percutaneous approaches after drainage removal in the postoperative period, the risk of developing an external pancreatic fistula is reduced.
[0046] Bibliography
[0047] 1. Sheth, Sunil G. et al. American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the management of chronic pancreatitis: summary and recommendations. Gastrointestinal Endoscopy, Volume 100, Issue 4, 584-594.
[0048] 2. Kawaguchi et al. Strategy of Endoscopic Pancreatic Duct Drainage for Recurrent Chronic Pancreatitis. Pancreatic Disorders & Therapy 2013, S3.
[0049] 3. Avanesyan R.G., Korolev M.P., Mikhailova E.A. Method of drainage of pancreatic ducts. 05.15.2016., Bulletin No. 14.
Claims
A method for frame drainage of the stricture of the terminal section of the main pancreatic duct (MPD) of the pancreas, characterized by the fact that percutaneous drainage of the MPD of the pancreas is performed, distinguished by the fact that the first stage involves percutaneous installation of a frame external-internal drainage in the lumen of the MPD of the pancreas at the border of the body and tail of the pancreas, after which, after 3 weeks, with adequate decompression of intraductal pancreatic hypertension, the second stage involves percutaneous installation of a second frame external-internal drainage at the border of the body and head of the pancreas through an access 2-3 cm proximal to the previous access.