Periampullary Carcinoma Resectable
Conditions
Keywords
Pancreaticoduodenectomy, Braun Anastomosis, Delayed Gastric Emptying
Brief summary
Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life. Braun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE. This study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.
Interventions
PROCEDUREBraun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy
Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
PROCEDUREPatients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, male or female; * Scheduled to undergo curative pancreaticoduodenectomy (PD); * Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction; * Mentally competent and able to provide written informed consent.
Exclusion criteria
* Age \< 18 years; * Prior diagnosis of gastroparesis; * Benign disease as the indication for PD; * Previous history of upper gastrointestinal surgery; * Preoperative pyloric obstruction; * Planned pylorus-preserving pancreaticoduodenectomy (PPPD); * Patients who have received neoadjuvant or conversion therapy; * Preoperative glycated hemoglobin (HbA1c) \> 7.5%; * Preoperative total bilirubin level \> 200 μmol/L; * Unable or unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delayed gastric emptying (DGE) | Postoperative days 1, 8, 15, and 22 | Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (days) | From first postoperative day to hospital discharge up to 15 weeks | Comparison of hospital stay duration between the intervention group and the control group. |
| Treatment cost | From the first postoperative day to one year follow-up | Evaluation of the difference in medical expenditure between the intervention group and the control group. |
| Postoperative recovery | From the first postoperative day to one year follow-up | Including time to first flatus, time to oral intake, and other related indicators. |
| Bile reflux | Assessment of bile reflux by 24-hour intragastric bilirubin monitoring. | — |
| Proportion of severe complications as defined by the Clavien-Dindo classification | From the first postoperative day to one year follow-up | — |
| Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively | 30 days | — |
Countries
China
Contacts
CONTACTYunlong Cui, PhD
Outcome results
None listed