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NCT Number: NCT07681128

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Yunlong Cui

CONTACT

[email protected]

+86 18622228633

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

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

Primary outcomes

  1. Incidence of delayed gastric emptying (DGE)

    Time frame: 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 outcomes

  1. Length of hospital stay (days)

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

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

  2. Treatment cost

    Time frame: 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.

  3. Postoperative recovery

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

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

  4. Bile reflux

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

  5. Proportion of severe complications as defined by the Clavien-Dindo classification

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

  6. Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yunlong Cui, PhD

CONTACT

[email protected]

+86 18622228633

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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