A Single Center Study of Efficacy and Safety Assessment of ERCP in Elderly Patients

Summary

This single-center study indicates that ERCP is a minimally invasive endoscopic procedure that is both safe and effective for older patients.

Abstract

Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as a valuable minimally invasive therapeutic method for pancreatobiliary diseases and is now utilized in numerous hospitals. As the population ages, greater attention must be paid to the risk of ERCP complications, since even minor issues can be fatal for older patients. The primary objective of this study was to compare the clinical outcomes of ERCP in elderly versus non-elderly patients, as well as to validate the procedure's safety and feasibility. Additionally, the article provides a detailed, step-by-step description of ERCP procedures to assist in clinical practice. Among the 1,240 patients who underwent ERCP in the past 5 years, over 65.5% were elderly. We compared the perioperative clinical data and success rates of both groups. After thorough preoperative evaluation, the analysis revealed no significant differences in overall success rates or complication rates between elderly and non-elderly patients. These results indicate that ERCP is a safe and effective intervention for elderly patients.

Introduction

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a cornerstone technique for diagnosing and treating biliopancreatic diseases. Compared to surgery, it offers significant advantages, including reduced trauma and direct, effective drainage, making it particularly valuable for managing these conditions in high-risk, frail elderly patients^1,2. With increasing life expectancy and improved healthcare, the demographic challenge of an aging population is prominent in China, leading to a rising proportion of elderly patients undergoing ERCP^3,4. However, ERCP carries inherent risks of serious complications such as bleeding, perforation, acute pancreatitis, and cholangitis. These risks are potentially amplified in the elderly population due to a higher prevalence of comorbidities (e.g., cardiovascular, neurological, and pulmonary diseases) and reduced physiological reserve. Consequently, heightened awareness of ERCP-related risks is imperative in this growing demographic, as even minor complications can have severe or fatal consequences^4,5.

While ERCP has demonstrated safety and efficacy in carefully selected elderly patients, robust comparative data evaluating procedural outcomes specifically between younger and older cohorts remain limited. Existing studies often focus on broad age ranges or lack granularity regarding technique modifications for the elderly. Critically, standard cannulation techniques may pose heightened challenges or risks in frail elderly patients due to anatomical variations or comorbidities^6,7.

To address this gap and enhance safety in this vulnerable population, we developed a novel stepwise protocol integrating titanium clip-assisted cannulation with pancreatic duct occupancy techniques. The rationale for this integrated approach is multifaceted: (1) Titanium clips can stabilize the papillary anatomy and facilitate targeted cannulation, potentially reducing traumatic attempts and associated risks like pancreatitis; (2) Pancreatic duct occupancy (e.g., via stent placement or guidewire maintenance) is a recognized strategy to prevent post-ERCP pancreatitis (PEP), a particularly concerning complication in the elderly; (3) Combining these techniques synergistically targets the two critical phases of ERCP most associated with complications (cannulation and PEP prevention), offering a tailored strategy for the anatomical and physiological vulnerabilities of elderly patients.

Therefore, the overall goal of this study is twofold: (1) To rigorously compare the efficacy and safety profile of ERCP between a high-aged cohort (≥71 years) and a younger control group (≤71 years) within a single center, ensuring patient selection based on ASA physical status ≤III, preserved cardiopulmonary function, and absence of uncorrected coagulopathy; and (2) To pioneer and validate the clinical application and outcomes of this novel integrated stepwise protocol specifically designed for elderly ERCP patients. This represents, to our knowledge, the first study to systematically evaluate and validate the application of this specific combined technical approach (titanium clip-assisted cannulation with pancreatic duct occupancy) in elderly patients undergoing ERCP.

Protocol

This study was approved by the ethics committees of Shanghai Tong Ren Hospital and Shanghai Jiao Tong University School of Medicine. (Ethics Approval No: A2023-085-01). Written informed consent was obtained from all participants or their legal guardians.

1. Preoperative preparation

1. Conduct a thorough preoperative assessment of the patient's physical condition. This includes a strict evaluation of the indications and contraindications for ERCP.
   1. Use the following inclusion criteria: Patients who require removal of bile duct stones (choledocholithiasis), relief of malignant or benign biliary obstruction (e.g., due to pancreatic cancer, cholangiocarcinoma, strictures) via stent placement or dilation, management of biliary leaks or fistulas, and treatment of chronic pancreatitis complications (e.g., ductal stones, strictures).
   2. Perform diagnostic (largely superseded by MRCP/EUS, but still applicable in specific scenarios) for evaluation of unexplained biliary obstruction where less invasive imaging (MRCP, EUS) is inconclusive or unavailable, for evaluation of pancreatic duct abnormalities where MRCP/EUS is inconclusive, for tissue sampling (cytology, biopsy) of biliary/pancreatic strictures or masses, for evaluation of sphincter of Oddi manometry (SOM) - rarely performed.
   3. Use the following exclusion criteria: Patient refusal or inability to provide informed consent; Uncorrected coagulopathy (INR > 1.5) or thrombocytopenia (platelets < 50,000/µL) that cannot be adequately managed; suspected or known perforated viscus (e.g., bowel perforation); unstable cardiopulmonary status precluding safe sedation/anesthesia.
   4. Exclude patients diagnosed with recent acute pancreatitis (unless ERCP is specifically indicated for its cause, e.g., impacted stone), recent myocardial infarction or unstable angina, severe pulmonary compromise (e.g., requiring high-flow oxygen), altered surgical anatomy (e.g., Billroth II, Roux-en-Y gastric bypass) increasing technical difficulty and risk, pregnancy (especially first trimester; radiation risk; ERCP if essential should be done with maximal shielding and obstetrical consultation), contrast allergy (requires premedication), inability to cooperate with the procedure despite sedation, lack of appropriate therapeutic intent or expertise (ERCP should generally not be performed purely for diagnostic purposes when safer alternatives exist).
      NOTE: This rigorous evaluation ensures that ERCP is performed only when clinically justified (clear indication present) and the potential benefits outweigh the risks (no absolute contraindication and relative contraindications mitigated or accepted based on urgency).
2. Perform imaging examinations, such as computed tomography (CT) and magnetic resonance cholangiopancreatography (MRCP), to evaluate biliopancreatic lesions and facilitate pre-planning of the procedure.

2. Exploration with a duodenoscope

1. Position the patient in a left lateral prone position under basic sedation. Using lateral vision, advance the duodenoscope orally through the esophagus and stomach, traverse the pylorus into the duodenum, and maneuver it into position facing the main papilla in the descending duodenum, utilizing CO₂ for insufflation.
2. Remove any residual gastric fluid by duodenoscope and identify the main duodenal papilla. Ensure safe access to the descending duodenum and confirm clear visibility of the papilla using both the lateral view of the duodenoscope and X-ray fluoroscopy.

3. Selective main papillary biliopancreatic duct cannulation

1. To identify the path of the common bile duct and main pancreatic duct, examine the pattern and opening of the main papilla.
2. Under direct endoscopic visualization, align the sphincterotome catheter with the main papilla's longitudinal axis, typically oriented toward the 11-12 o'clock position. Advance the hydrophilic-tipped guidewire 2-3 mm beyond the catheter tip.
3. Using fine elevator control and subtle torque, gently probe the orifice while applying upward tension on the sphincterotome. Upon encountering the biliary lumen trajectory, advance the guidewire smoothly under fluoroscopic guidance.
4. Confirm correct biliary (rather than pancreatic) access using fluoroscopic visualization of wire movement rightward and cephalad toward the liver hilum, and aspiration of golden-brown bile through the sphincterotome channel.
   NOTE: Titanium clips can assist in exposing the opening of the main papilla if it is not adequately visualized. When it's hard to cannulate the bile duct, employing the pancreatic duct occupancy method and pre-cutting the main papilla can increase the success rate.

4. Endoscopic retrograde cholangiopancreatography

1. To optimize ductal visualization and mitigate procedural risks, aspirate bile or pancreatic fluid through the sphincterotome channel under fluoroscopic guidance prior to contrast injection.
2. Under continuous fluoroscopic monitoring, gradually inject iodinated contrast medium (diluted to 25-50% concentration with sterile saline) using a controlled-pressure syringe.
3. Begin with a 0.5-1 mL test injection to confirm access, then administer 5-15 mL in 2-3 mL aliquots for biliary opacification (pausing to assess flow) or limit to 2-5 mL total volume (<1 mL/s) for pancreatic duct filling to prevent acinarization; during injection, document stricture characteristics (location/length/contour), differentiate filling defects (mobile convex stones versus fixed irregular tumors), map ductal variants, and acquire dynamic images in multiple projections (Anteroposterior/oblique/lateral) with video recording for complex pathology.

5. Specific biliopancreatic drainage strategies

1. Achieve selective cannulation of cholangiopancreatic strictures using a conventional guidewire, an incisional knife, a balloon, and direct visualization with a cholangioscopy.
2. For malignant nonoperative extrahepatic bile duct strictures, as well as Bismuth-Corlette I, II, and III hilar strictures, prefer metal stent drainage to maximize bile drainage and reduce the need for repeat ERCP treatments.
   1. For Bismuth-Corlette IV hilar strictures, or as a complementary approach with metal stents, choose a plastic stent and nasobiliary drainage. In cases of acute cholangitis where intrahepatic and extrahepatic bile duct stones cannot be removed in a single attempt, opt for plastic stent drainage.
3. Once the stones are fully removed, transition to nasobiliary drainage.

6. Specific stone extraction strategies

1. Initially, under direct lateral vision, make a controlled incision along the superior axis (11-1 o'clock direction) using a pure-cut current via sphincterotome, limiting the cut length to ≤ 1/3^rd of the papillary mound height and never extending beyond the transverse fold; confirm adequate size by visualizing free bile flow and the ability to pass a 6-8 mm dilation balloon without resistance. Confirm bile duct stones by choledochoscopic visualization prior to stone extraction.
2. After securing biliary access, advance a hydrostatic dilation balloon catheter (6-12 mm diameter) over the guidewire under fluoroscopy. Position the balloon centrally across the stricture using radiopaque markers.
3. Gradually inflate with diluted contrast via a pressure-controlled syringe to rated pressure (typically 8-12 atm), maintaining inflation for 1-3 min until fluoroscopy confirms complete disappearance of the balloon waist. Deflate and withdraw the balloon while leaving the guidewire in place for subsequent therapy.
4. After confirming successful sphincterotomy or balloon dilation, advance a stone extraction balloon (for small/multiple stones) or basket (for large stones) over the guidewire under fluoroscopy. Position the device proximal to the stone(s), inflate the balloon with diluted contrast, and gently withdraw while maintaining constant tension to extract stones through the papilla.
   1. Alternatively, engage stones in the basket under direct fluoroscopic visualization and extract with controlled traction. For impacted stones, employ mechanical lithotripsy by closing the basket around the stone and applying incremental force via the crank handle until fragmentation.
5. Confirm complete clearance via cholangiogram and visualize bile flow. Following incomplete stone removal in frail individuals, deploy a 7-10 Fr plastic biliary stent across the papilla to ensure drainage, enabling staged ERCP sessions for definitive clearance.
   NOTE: For papillary columnar balloon dilatation, when the stone is larger than the diameter of the lower end of the common bile duct, the columnar balloon is chosen directly according to the common bile duct; when the stone is smaller than the diameter of the lower end of the common bile duct, the columnar balloon is chosen according to the size of the stone. Patience and focus are crucial to maintain the stability of the guidewire and ensure effective stone removal and stent placement.

7. Postoperative therapeutic measures and surveillance content

1. In postoperative treatment, include pancreatic enzyme blockers, gastric acid suppressants, anti-infective treatments, and rehydration therapy.
2. During the postoperative period, monitor routine blood counts, liver function, blood amylase, and nasobiliary drainage. Additionally, conduct necessary follow-up abdominal imaging, such as CT and MRCP, as required.

Results

We retrospectively assembled ERCP cases from the previous 5 years by examining historical and follow-up information to ensure accuracy. From January 2020 to November 2024, a total of 1,240 ERCPs were performed on 1,133 patients aged 16 to 102 years, with a median age of 71. Procedural success was defined as complete stone clearance, adequate stent placement, or resolution of biliary obstruction confirmed by fluoroscopy/cholangioscopy. Among them, 405 patients (438 procedures) were 65 year...

Discussion

ERCP, being less invasive than surgery, is highly effective in diagnosing and treating biliopancreatic diseases through direct drainage, making it an optimal choice for elderly and frail patients⁸. As minimally invasive treatments become more popular, there has been a notable increase in elderly patients requiring ERCP. This trend is accompanied by rising co-morbidities, increased use of medications such as anticoagulants, and complexities in endoscopic procedures, which together drive a high...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
CleverCut 3V	Olympus Medical	KD-V411M-0725	selective biliary cannulation and papillary sphincterotomy
Duodenoscopy	Olympus Medical	TJF-260V	Endoscopy for ERCP
EyeMAX	Micro-Tech (Nanjing) Co.Ltd	CDS22001	Disposable ultrafine peroral cholangioscope
Flexima Biliary Stent	Boston Scientific	M00539260	Biliary stent drainage
Fusion Extraction Balloon With Multiple Sizing	Cook Medical	G31537	Balloon for clearing bile duct stones
Fusion Titan Biliary Dilation Balloon	Cook Medical	FS-BDB-6X4	Dilatation of the primary papilla
Jagwire High Performance Guidewire	Boston Scientific	M00556580	Guidewire
LithoCrushV Mechanical Lithotriptor	Olympus Medical	BML-V442QR-30	Mesh basket for lithotripsy
Nasal Biliary Drainage Sets	Cook Medical	ENBD-7-LIGUORY	Nasobiliary drainage
Optional repeatable opening and closing of soft tissue clips	Micro-Tech (Nanjing) Co.Ltd	ROCC-D-26-195	Titanium clips
TetraCatch V	Olympus Medical	FG-V432P	Mesh basket for stone removal
Zimmon Pancreatic Stent	Cook Medical	SPSOF-5-5	Pancreatic Duct Stent Drainage