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Clinical Trials in China / NCT07681128
Recruiting Not applicable

The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy

NCT07681128 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Not applicable
Started
2026-03-30
Last updated
2026-07-02

Condition(s) studied

Periampullary Carcinoma Resectable

Investigational drug(s) / intervention(s)

Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomyPatients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy: Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).

Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.: Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting

More Tianjin Medical University Cancer Institute and Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07681128 on ClinicalTrials.gov ↗ ← All trials in China