Hepatolithiasis, Sphincter of Oddi Dysfunction
Conditions
Keywords
Hepatolithiasis, Sphincter of Oddi Dysfunction, Roux-en-Y hepaticojejunostomy, randomized controlled trial
Brief summary
Objective: Evaluate the role of Roux-en-Y hepaticojejunostomy (RYHJ) in hepatolithiasis patients with sphincter of Oddi laxity (SOL). Summary Background Data: Hepatolithiasis poses high risks of residual, recurrence, and re-intervention. SOL significantly impacts this condition. RYHJ has been recommended for hepatolithiasis concomitant SOL but without prospective evidence. Methods: This is an open-label randomized controlled trial recruiting patients with hepatolithiasis concurrent SOL. Patients were randomly assigned (1:1) to undergo RYHJ or not. The primary endpoint was stone occurrence, including residual and recurrence, within a three-year postoperative period. Secondary endpoints incorporated perioperative and long-term outcomes, like episodes of cholangitis and invasive re-interventions for stones and related complications. The analyses followed the intention-to-treat principle.
Interventions
PROCEDURERoux-en-Y hepaticojejunostomy
All participants received routine perioperative care and followed the same surgical principles: removing affected liver segments, clearing stones, correcting strictures, and then restoring bile drainage. The primary indications for hepatectomy were unilobar or segmental diseases and the presence of the following lesions in the affected liver segment or lobe: 1) multiple stones with biliary strictures that cannot be cured via choledochoscopy, 2) atrophy, fibrosis, and multiple abscesses, and 3) suspicious neoplasia. Biliary exploration was routinely conducted to facilitate stone removal, rectify strictures, and assess the functionality of the Oddi sphincter. Following this, patients would be evaluated for eligibility and assigned accordingly. The sole distinction between the two arms was performing RYHJ or maintaining the common bile duct for bile drainage.
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. aged between 18 and 80 years 2. diagnosed with SOL during operation 3. suitable for a radical surgery including RYHJ 4. hopeful to clear stones via operation or combined with subsequent choledochoscopy 5. provided written informed consent 6. willing to complete a 3-year follow-up An intraoperative diagnosis of SOL was established if the rhythmic contraction and relaxation of the sphincter of Oddi were not observed under choledochoscope and the flexible choledochoscope (CHF-P20, external diameter, 4.9 mm; Olympus, Tokyo, Japan) could navigate smoothly to the duodenum through the sphincter of Oddi without any pre-dilation interventions.
Exclusion criteria
1. with imaging evidences of tumor preoperatively 2. had congenital biliary malformations 3. had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of stones, including residual and recurrent stones, within three years postoperatively. | A three-year postoperative period | The term stone occurrence pertained to the identification of any bile duct stones with the most reliable imaging modality available during the follow-up period. Stone residual described a patient in whom stones were detected during the initial follow-up examination, while stone recurrence referred to a patient who exhibited no stones at the first follow-up visit but subsequently presented with stones during later follow-up assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major complications | perioperation | Postoperative complications were graded according to the Clavien-Dindo definition and those ranked Grade III or above were defined as major complications. Complications arising during unplanned readmission were also taken into account. |
| Episodes of cholangitis | 3-year follow-up period | Episodes of cholangitis, regardless of definite or suspected one. The diagnosis of cholangitis were initially established according to the Tokyo 2007 guidelines and were subsequently revised following the Tokyo 2018 guidelines. |
| Invasive re-interventions for stones and related complications | 3-year follow-up period | The term invasive re-interventions covered operation, percutaneous transhepatic cholangioscopy, and endoscopic retrograde cholangiopancreatography. The planned choledochoscopy following the initial surgical procedure was not lumped into invasive re-interventions. |
| Medical expenses | perioperation | Medical expenses covered all costs incurred throughout the course, including planned choledochoscopy and unplanned readmissions. |
| Unplanned readmission within 30 days postoperatively | perioperation | — |
| Postoperative hospital stays | perioperation | Hospital stays arising during unplanned readmission were also taken into account |
Other
| Measure | Time frame |
|---|---|
| Cholangiocarcinoma arising | 3-year follow-up period |
Countries
China
Outcome results
None listed