Method of endoscopic retrograde intervention on organs of pancreatobiliary zone

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine, specifically to surgical endoscopy, and can be used for endoscopic retrograde intervention on the organs of the pancreatobiliary zone. The method includes duodenoscopy, selective cannulation of the common bile duct, endoscopic retrograde cholangiopancreatography, and endoscopic papillosphincterotomy. Prior to performing selective cannulation of the common bile duct, gas is desufflated from the lumen of the duodenum, followed by its filling with a physiological solution cooled to 1–4  °C, to which peppermint tincture has been added, at a rate of 40–60 drops per 1 L of physiological solution. Immediately after filling, selective cannulation of the common bile duct is carried out. Subsequent endoscopic papillosphincterotomy is performed under the conditions of the specified liquid medium, under endoscopic control.EFFECT: invention makes it possible to increase the effectiveness of retrograde intervention on the organs of the pancreatobiliary zone by reducing duodenal peristalsis without systemic drug intervention, reducing thermal damage to tissues, and, subsequently, potentially reducing the incidence of postoperative complications.1 cl, 1 dwg, 2 ex

Description

[0001] The invention relates to medicine, namely to surgical endoscopy, and can be used in the treatment of patients with pathology of the bile ducts and pancreatic ducts.

[0002] Currently, endoscopic transpapillary surgery (ETS) is increasingly used to treat various diseases of the pancreatobiliary system, demonstrating its high efficiency. At the same time, an acceptable level of complications is noted, even in elderly patients with severe comorbidities (Koklti S. et al, Endoscopic retrograde cholangiopancreatography in the elderly: a prospective and comparative study, Age Ageing, 2005, 34(6), p. 572-577; Thomopoulos KC et al, Endoscopic retrograde cholangiopancreatography is a safe and effective method for diagnosis and treatment of biliary and pancreatic disorders in octogenarians, Acta Gastroenterol Belg., 2007, 70(2), p. 199-202). It is important to note that the morbidity and mortality rates after endoscopic interventions are significantly lower compared to traditional Carr-Locke DL surgeries., Therapeutic role of ERCP in the management of suspected common bile duct stones, Gastrointest Endosc, 2002, 56(6), p. S170-174).

[0003] Among the main complications of ERCP are acute post-manipulation pancreatitis, bleeding, cholangitis and retroduodenal perforation (Loperfido S. et al, Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study, Gastrointest Endosc, 1998, 48(1), p. 1-10; Salminen P. et al, Severe and fatal complications after ERCP: analysis of 2555 procedures in a single experienced center, Surg Endosc, 2008, 22, p. 9). The most common complication of ERCP is acute post-manipulation pancreatitis, the incidence of which varies from 2% to 15%, with a clinically significant complication recorded in 1%-5% of patients (Loperfido S. et al, Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study, Gastrointest Endosc, 1998, 48(1), p. 1-10; Freeman ML et al, Complications of endoscopic biliary sphincterotomy, N Engl J Med., 1996, 335(13), p. 909-918).

[0004] Various risk factors for the development of acute post-manipulation pancreatitis are identified, one of which is difficult bile duct cannulation (Freeman M. L. et al, Risk factors for post-ERCP pancreatitis: a prospective, multicenter study, Gastrointest Endosc, 2001, 54 (4), p. 425-434). The incidence of complications at the stage of bile duct cannulation varies from 4% to 30% depending on different studies, and unsuccessful biliary cannulation is observed in 20% of cases of POP and is itself associated with a higher risk of complications Freeman M. L. et al, ERCP cannulation: a review of reported techniques, Gastrointest Endosc, 2005, 61 (1), p. 112-125; Williams EJ. et al, Are we meeting the standards set for endoscopy? Results of a large-scale prospective survey of endoscopic retrograde cholangio-pancreatograph practice, Gut., 2007, 56(6), p. 821-829).

[0005] Difficult cannulation refers to cases in which selective biliary cannulation using standard methods is difficult. Most definitions of difficult cannulation use a combination of a minimum number of cannulation attempts (usually 5 to 15) and a minimum time spent using standard cannulation methods (usually more than 5-20 minutes) (Berry R. et al., Difficult biliary cannulation: Historical perspective, practical updates, and guide for the endoscopist, World J Gastrointest Endosc, 2019, 11(1), pp. 5-21).

[0006] The number of inadvertent injections or cannulations of the main pancreatic duct may also be considered part of the definition of difficult cannulation, with some studies suggesting more than 4 Wirsung duct cannulations as a limit (Dumonceau J.-M. et al, Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014, Endoscopy, 2014, 46(9), p. 799-815). In the European Society of Gastrointestinal Endoscopy (ESGE) guidelines, difficult biliary cannulation with an intact major duodenal papilla (MDP) was defined as any intervention in which the cannulation duration exceeded 5 minutes or 5 attempts, or more than one inadvertent cannulation or opacification of the main pancreatic duct (Berry R. et al, Difficult biliary cannulation: Historical perspective, practical updates, and guide for the endoscopist, World J Gastrointest Endosc, 2019, 11(1), p. 5-21).

[0007] Studies have shown that the risk of developing acute post-manipulation pancreatitis significantly increased with the transition to atypical methods of endoscopic papillotomy and pancreatography (Masci E. et al., Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis, Endoscopy, 2003, 35(10), p. 830-834). The risk of developing acute pancreatitis after POC also increases in centers that perform a low volume of such procedures (<200 POCs per year) and a low rate of POCs per endoscopist (<40 per year) (Berry R. et al., Difficult biliary cannulation: Historical perspective, practical updates, and guide for the endoscopist, World J Gastrointest Endosc, 2019, 11(1), p. 5-21).

[0008] In an effort to improve cannulation performance, numerous methods and instruments have been developed that not only facilitate biliary cannulation but also reduce the risk of complications. However, the problem of difficult cannulation remains, despite the many proposed methods.

[0009] In addition to the complications described above, the literature also describes rather rare complications of POP associated with excessive insufflation of air or carbon dioxide. Examples of such adverse events include cases of pneumoperitoneum resulting from damage to the Gleason capsule (Assimakopoulos SF et al, A rare etiology of post-endoscopic retrograde cholangiopancreatography pneumoperitoneum, World J Gastroenterol., 2008, 14(18), p. 2917-2919) and fatal cerebral arterial air embolism (Rangappa P. et al, Fatal cerebral arterial gas embolism after endoscopic retrograde cholangiopancreatography, Indian J Crit Care Med., 2009, 13(2), p. 108-112).

[0010] In the modern literature, more and more publications are appearing on the topic of underwater endoscopy. There are reports on underwater endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc. (Sferrazza S. et al., Underwater Techniques in Gastrointestinal Endoscopy: Diving into the Depths, Cancers (Basel)., 2024, 16(20), p. 3535).

[0011] The performance of endoscopic underwater papillectomy is described (Granata A. et al, Endoscopic ampullectomy: to inject or not to inject? The underwater technique, Endoscopy, 2014, 46(1) p. E478-479).

[0012] There are several studies on endoscopic cannulation of the bile duct in a gel medium (Soga K. et al., Effectiveness of gel-immersion endoscopy for examination for suspected pancreaticobiliary maljunction, Endoscopy, 2024, 56(1), p. E489-E490); Ban T. et al., Gel-immersion biliary cannulation during a balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography, Endoscopy, 2025, 57(1), p. C. 329-330). In this case, a special gel was used, which is not registered in the Russian Federation. The literature mentions a single clinical observation of performing ERCP in an aquatic environment using an endoscope with end-on optics (Batarseh C. et al, Innovative Use of Underwater Technique to Facilitate ERCP in the Setting of Anatomic and Inflammatory Barriers in Acute Pancreatitis, Am J Gastroenterol., 2025, 120(10S2),p. S1141-S1141).

[0013] Today, it is known that filling the lumen of the duodenum with saline solution helps straighten its folds, which can have a positive effect at the stage of bile duct cannulation (Batarseh C. et al, S5348 Innovative Use of Underwater Technique to Facilitate ERCP in the Setting of Anatomic and Inflammatory Barriers in Acute Pancreatitis, Am J Gastroenterol., 2025, 120(10S2), p. SI 141-SI 141). In addition, water enhances the endoscopic image and clears the mucous membrane of mucus and food fragments (Binmoeller K. F. et al, “Underwater” EMR without submucosal injection for large sessile colorectal polyps (with video), Gastrointest Endosc, 2012, 75(5), p. 1086-1091). The minimal volume of insufflated air / gas reduces the risk of cardiopulmonary complications after anesthesia and helps reduce pain in the postoperative period (Luo W.et al, Low Pneumoperitoneum Pressure Reduces Gas Embolism During Laparoscopic Liver Resection: A Randomized Controlled Trial, Ann Surg., 2024, 279(4), p. 588-597; Saway JP et al, Review of Outcomes of Low Verses Standard Pressure Pneumoperitoneum in Laparoscopic Surgery, Am Surg., 2022, 88(8), p. 1832-1837). The aqueous environment also reduces direct thermal tissue damage due to its thermal conductivity (Tseng C.-W. et al, Heat sink effect of underwater polypectomy in a porcine colon model, BMC Gastroenterol., 2021, 21(1), p. 406), which may likely reduce the risk of developing acute post-manipulation pancreatitis. This effect was demonstrated in a study in which 250 ml of ice water was injected into the lumen of the duodenum in the projection of the duodenal papilla after completion of the ERCP, which confirmed the safety and effectiveness of the proposed technique (Azuma S. et al, Cooling the papilla with ice water in preventing post-ERCP pancreatitis (ice water challenge study), Surg Endosc, 2022, 36(8), p.6002-6006). However, all stages of the operation were carried out under air insufflation conditions.

[0014] Reduced duodenal peristalsis during duodenal cannulation is a pressing issue when performing PEO. The search for an effective and safe method for reducing peristalsis during PEO has been ongoing for a long time. The use of hyoscine butylbromide and glucagon has been described as agents for suppressing duodenal peristalsis; however, their use may be limited by the risk of adverse events and the presence of contraindications in high-risk patients (Forbes N. et al, Canadian Association of Gastroenterology (CAG) Position Statement on the Use of Hyoscine-n-butylbromide (Buscopan) During Gastrointestinal Endoscopy, Journal of the Canadian Association of Gastroenterology, 2021, 4(6), p. 259-268; Perisetti A. et al, Clinical safety and outcomes of glucagon use during endoscopic retrograde cholangiopancreatography (ERCP), Endosc Int Open., 2022, 10(4), p. E558-E561).

[0015] There are data in the literature on the effectiveness of peppermint oil and the herbal preparation "Shakuyakukanzoto" (a combination of peony root and licorice), but their clinical use is limited (Fujinami H. et al., The influence of duodenally-delivered Shakuyakukanzoto (Shao Yao Gan Cao Tang) on ​​duodenal peristalsis during endoscopic retrograde cholangiopancreatography: a randomized controlled trial, Chin Med., 2017, 12, p. 3; Yamamoto N. et al., Efficacy of peppermint oil as an antispasmodic during endoscopic retrograde cholangiopancreatography, J Gastroenterol Hepatol., 2006, 21(9), p. 1394-1398). The use of L-menthol when performing endoscopic transpapillary interventions provides suppression of peristalsis, facilitates cannulation, shortens the duration of the intervention and reduces the risk of intraoperative complications (Anishchenko M.A. et al., Use of L-menthol in endoscopic transpapillary interventions.A prospective, randomized, two-center study, Russian Journal of Gastroenterology, Hepatology, Proctology, 2023, 33(5), pp. 78-87). Intraluminal local spraying of lidocaine was studied as an alternative method of reducing motility and demonstrated its effectiveness (Suzuki M. et al., Inhibitory Effect of Lidocaine on Duodenal Peristalsis During Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Trial (With Video), DEN Open., 2026, 6(1), p. e70252).

[0016] Previously described methods for reducing peristalsis and preventing complications during POP were used in the vast majority of cases under air or carbon dioxide insufflation. Consequently, the risks of thermal tissue damage and cardiopulmonary complications remained. A clinical observation on cannulation of the pancreatic duct in an aqueous environment described the use of an endoscope (gastroscope) not standard for POP, which precludes a reliable assessment of the method's effectiveness. Furthermore, the duodenal lumen was filled with room-temperature saline without the addition of drugs to reduce peristalsis.

[0017] Studies on performing PPO in a gel environment used a specialized gel that is not registered in the Russian Federation, limiting its practical applicability in our country. In studies where the duodenum was filled with a cold solution after the procedure, the procedure itself was performed in an air environment, meaning potential risks associated with insufflation and thermal exposure were not completely eliminated.

[0018] Thus, there is a need for a method of endoscopic retrograde intervention on the organs of the pancreatobiliary zone that is free from the above-mentioned disadvantages.

[0019] The technical result of the proposed invention is to increase the effectiveness of retrograde intervention on the organs of the pancreatobiliary zone by reducing duodenal peristalsis without systemic drug exposure, reducing thermal damage to tissues and, subsequently, potentially reducing the frequency of postoperative complications.

[0020] In order to achieve the specified technical result in the method of endoscopic retrograde intervention on the organs of the pancreatobiliary zone, including duodenoscopy, selective cannulation of the common bile duct, endoscopic retrograde cholangiopancreatography and endoscopic papillosphincterotomy, it is proposed to desufflate gas from the lumen of the duodenum before performing selective cannulation of the common bile duct, followed by filling it with a saline solution cooled to 1-4°C with peppermint tincture added to it, at the rate of 40-60 drops per 1 liter of saline solution, immediately after filling, selective cannulation of the common bile duct is performed, subsequent endoscopic papillosphincterotomy is performed in the conditions of the specified liquid medium under endoscopic control.

[0021] The method is carried out as follows.

[0022] The procedure is performed in the X-ray operating room under endotracheal anesthesia. The duodenoscope's instrument channel is equipped with a special adapter connected to an irrigation pump. With the patient supine, the duodenoscope is inserted into the duodenum, visualizing the duodenal duodenum. The supine position ensures prolonged fluid retention on the posteromedial wall of the duodenum. After visualizing the duodenal duodenum in air and clearing the mucosa of intestinal contents, gas (air / CO2) is desufflated from the duodenal lumen. Next, the duodenum is filled with saline solution containing peppermint tincture, at a rate of 40-60 drops per liter, through the endoscope's instrument channel. The solution is infused in a volume sufficient to visualize and straighten the anatomical structures of the duodenum. The solution temperature is 1-4°C.A cooled solution with added peppermint tincture is brought to the operating room in a sterile thermos. The peppermint tincture has the following composition: peppermint leaves - 50 g; peppermint oil - 50 g with a 50% L-menthol content; excipient: ethanol (ethyl alcohol) 90% - sufficient to obtain 1000 ml of tincture. The average weight of one drop of tincture is 0.05 grams (50 mg). Both saline solution cooled to the specified temperature range and peppermint tincture solution at the specified optimal concentration help to reduce duodenal peristalsis. Cannulation of the common bile duct is performed according to the generally accepted technique using standard sets of instruments (catheters, various types of papillotomes, guidewires, etc.). Endoscopic papillosphincterotomy is also performed under the conditions of the specified liquid medium (saline solution with peppermint tincture).The papillary segment of the terminal common bile duct (within the transverse fold) is dissected, providing the necessary access for subsequent procedures. After the procedure, the solution is aspirated from the lumen of the duodenum and stomach, and the endoscope is removed.

[0023] Our proposed method involves performing all stages of the surgery in an aqueous environment, filling the duodenum with cold saline solution containing peppermint tincture. The combination of a local cooling effect and antispasmodic action allows for rapid reduction in duodenal peristalsis without systemic medication, a reduction in thermal tissue damage, and, subsequently, a potential reduction in the incidence of postoperative complications.

[0024] Reducing gas insufflation at all stages of the procedure creates the preconditions for minimizing cardiopulmonary risks and improving the postoperative course. Additionally, increased visualization and reduced intestinal motility in a clear fluid medium can contribute to increased effectiveness of selective bile duct cannulation and a shorter learning curve for novice specialists.

[0025] The high efficiency of the proposed method is confirmed by the clinical examples below.

[0026] Example. Patient K., 65 years old. Hospitalized in the surgical department of the M.F. Vladimirsky Regional Scientific Research Institute with a diagnosis of cholelithiasis and choledocholithiasis. Laboratory results are within normal limits.

[0027] On January 15, 2025, a transluminal transluminal operation was performed. A duodenoscope was inserted into the descending duodenum, where the duodenal duodenum (BD) was visualized on the posteromedial wall, located along the edge of a diverticulum. Visualization was hampered by a large amount of foamy material, bile, the presence of a diverticulum, and active intestinal peristalsis. CO2 desufflation was performed, followed by filling the intestinal lumen with a saline solution at 1°C with 60 drops of peppermint tincture (3 g of tincture per 1 liter of saline). The lumen of the descending duodenum was completely straightened. When examined in a liquid medium, the duodenal duodenum structures were more clearly visualized due to the absence of foamy material and the magnification effect of the endoscopic image. A significant decrease in intestinal peristalsis and image stabilization were also noted.Cannulation of the common bile duct was performed using a standard technique, using a papillotome and guidewire, and endoscopic retrograde cholangiography (ERCP) with Ultravist contrast agent. Contrast imaging revealed a dilated common bile duct with a round filling defect measuring 7 mm in diameter. Endoscopic papillosphincterotomy was performed. A stone was removed from the bile duct using a balloon extraction. Control contrast imaging revealed a homogeneous bile duct lumen, with free flow of bile and constant substance. Saline solution containing peppermint tincture was aspirated from the gastric lumen. The endoscope was withdrawn.

[0028] The postoperative period was uneventful. The patient was discharged from the hospital on the fourth day in satisfactory condition.

[0029] Example 2. Patient D., 60 years old. Hospitalized in the oncology department of the M.F. Vladimirsky Regional Scientific Research Institute with a diagnosis of a bile duct tumor of uncertain or unknown nature. Computed tomography of the abdominal organs reveals a distal common bile duct tumor measuring 22 × 10 × 9 mm. Laboratory tests reveal an increase in total bilirubin to 31.2 mmol / L due to the direct fraction (17.72 μmol / L), and a decrease in hemoglobin to 114 g / L. The patient has a history of cholecystectomy.

[0030] On March 19, 2025, a transluminal abdominal cavity examination was performed. The duodenoscope was inserted into the descending portion of the duodenum. A duodenal ulcer with a moderately tense longitudinal fold located along the edge of the diverticulum, up to 10 mm in diameter, was detected on the posteromedial wall. Difficult visualization of this area was noted due to the large amount of foam and pronounced intestinal peristalsis (Fig. 1.1, Fig. 1.2). CO2 desufflation was performed, followed by filling the intestinal lumen with a saline solution at a temperature of 4°C with the addition of 40 drops of peppermint tincture (2 g of tincture per 1 liter of saline). The lumen of the duodenum was completely straightened with active supply of the solution, which helped to reduce intestinal peristalsis and stabilize the image (Fig. 1.3). When examined in an aquatic environment, the structures of the intestinal tract are more clearly differentiated due to the absence of intestinal contents and the magnification effect of the endoscopic image.Cannulation of the common bile duct was performed using a standard technique with a papillotome and guidewire (Fig. 1.4) and endoscopic retrograde cholangiography (ERCP) using the Omnipaque contrast agent. Contrast enhancement visualized dilated extrahepatic bile ducts, up to 20 mm in diameter, and a single oval-shaped filling defect, 18 mm in diameter, was identified in the terminal section of the common bile duct. Endoscopic papillosphincterotomy was performed. The stone was removed into the duodenal lumen using an extraction balloon. Control contrast enhancement revealed a homogeneous bile duct lumen, with free flow of constant substance and bile. The entire volume of the previously administered solution was aspirated from the intestinal and gastric lumen. The endoscope was withdrawn.

[0031] The postoperative period was uneventful. The patient was discharged from the hospital on the fifth day in satisfactory condition.

Claims

A method of endoscopic retrograde intervention on the organs of the pancreatobiliary zone, including duodenoscopy, selective cannulation of the common bile duct, endoscopic retrograde cholangiopancreatography and endoscopic papillosphincterotomy, characterized in that before selective cannulation of the common bile duct, gas is desufflated from the lumen of the duodenum, followed by filling it with a saline solution cooled to 1-4°C with peppermint tincture added to it, at a rate of 40-60 drops per 1 liter of saline solution, immediately after filling, selective cannulation of the common bile duct is performed, subsequent endoscopic papillosphincterotomy is performed in the conditions of the said liquid medium under endoscopic control.

Images