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.

Study Overview

• Status: Recruiting
• Conditions: Periampullary Carcinoma Resectable
• Intervention / Treatment: Procedure: Braun anastomosis on delayed gastric emptying (DGE) in reconstruction after pancreaticoduodenectomy; Procedure: Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunlong Cui, PhD; Phone Number: +86 18622228633; Email: ningyunlong@163.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Yunlong Cui; Phone Number: +86 18622228633; Email: ningyunlong@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Braun arm; PD with Billroth II reconstruction plus Braun anastomosis	Procedure: 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).
Other: Non Braun Arm; PD with Billroth II reconstruction alone (without Braun anastomosis)	Procedure: Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.; Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delayed gastric emptying (DGE)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (days)	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	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	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		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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pancreaticoduodenectomy; Delayed Gastric Emptying; Braun Anastomosis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroparesis
• Other Study ID Numbers: Braun-HCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No