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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age < 18 years;

Prior diagnosis of gastroparesis;

Benign disease as the indication for PD;

Previous history of upper gastrointestinal surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy

    Procedure/Surgery

    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.

    Procedure/Surgery

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

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: Braun armExperimental treatment 1 intervention
Group B: Non Braun ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of delayed gastric emptying (DGE)

Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria

Time frame
Postoperative days 1, 8, 15, and 22

Secondary outcomes

1

Length of hospital stay (days)

Comparison of hospital stay duration between the intervention group and the control group.

Time frame
From first postoperative day to hospital discharge up to 15 weeks
2

Treatment cost

Evaluation of the difference in medical expenditure between the intervention group and the control group.

Time frame
From the first postoperative day to one year follow-up
3

Postoperative recovery

Including time to first flatus, time to oral intake, and other related indicators.

Time frame
From the first postoperative day to one year follow-up
4

Bile reflux

Time frame
Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.

Other outcomes

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