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

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

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

264

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Studiesteder

    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300060
        • Rekruttering
        • Tianjin Medical University Cancer Institute & Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Braun arm
PD with Billroth II reconstruction plus Braun anastomosis
Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
Andet: Non Braun Arm
PD with Billroth II reconstruction alone (without Braun anastomosis)
Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of delayed gastric emptying (DGE)
Tidsramme: 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
Postoperative days 1, 8, 15, and 22

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospital stay (days)
Tidsramme: From first postoperative day to hospital discharge up to 15 weeks
Comparison of hospital stay duration between the intervention group and the control group.
From first postoperative day to hospital discharge up to 15 weeks
Treatment cost
Tidsramme: 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.
From the first postoperative day to one year follow-up
Postoperative recovery
Tidsramme: From the first postoperative day to one year follow-up
Including time to first flatus, time to oral intake, and other related indicators.
From the first postoperative day to one year follow-up
Bile reflux
Tidsramme: Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
Proportion of severe complications as defined by the Clavien-Dindo classification
Tidsramme: From the first postoperative day to one year follow-up
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
Tidsramme: 30 days
30 days

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. april 2026

Mere information

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