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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Yunlong Cui, PhD
- 電話番号:+86 18622228633
- メール:ningyunlong@163.com
研究場所
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300060
- 募集
- Tianjin Medical University Cancer Institute & Hospital
-
コンタクト:
- Yunlong Cui
- 電話番号:+86 18622228633
- メール:ningyunlong@163.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Braun arm
PD with Billroth II reconstruction plus Braun anastomosis
|
Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
|
|
他の:Non Braun Arm
PD with Billroth II reconstruction alone (without Braun anastomosis)
|
Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of delayed gastric emptying (DGE)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of hospital stay (days)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:30 days
|
30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。