Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy

Официальное название

Safety and Feasibility of Omitting Nasogastric Decompression in Minimally Invasive Pancreaticoduodenectomy: a Multicenter Non-inferiority Randomized Controlled Trial

Обзор

This study will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery. Participants will be randomly assigned to one of two groups. Each group will receive the assigned nasogastric tube strategy during and after surgery, and will be followed during the hospital stay and after discharge for up to postoperative 90 days. Information will be collected from routine clinical care, including discomfort score, symptoms, imaging or laboratory tests when clinically indicated, and postoperative outcomes. The main outcome of this study is the overall burden of postoperative complications within 30 days after surgery, measured using the Comprehensive Complication Index, which summarizes all complications into a single score. Secondary outcomes include rates of pancreas surgery-specific complications (such as delayed gastric emptying, pancreatic fistula, bile leak, bleeding, and chyle leak), other abdominal and pulmonary complications, and organ dysfunction (including kidney injury, sepsis, and new cardiac dysfunction). The study will also evaluate patient discomfort related to the nasogastric tube (pain/discomfort scores), the need for nasogastric tube reinsertion, postoperative recovery milestones (ability to resume oral intake and length of hospital stay), healthcare costs, and all-cause mortality at 30 and 90 days after surgery.

Вмешательства

• Процедура nasogastric tube decompression
  Nasogastric tube decompression means standard NGT placement with the tube retained postoperatively until the drainage volume is \<500 ml/day on postoperative day 3. Nasogastric tube placement will adhere to the following requirements: pre-insertion nasal patency assessment excluding the side with septal deviation or polyps, catheter pre-measurement from the apex nasi to the ear lobe and xiphoid process, and lubrication with liquid paraffin. After advancement into the pharynx, conscious patients
• Процедура Omission of nasogastric tube decompression
  Omission of nasogastric tube decompression means avoidance of prophylactic NGT placement throughout the perioperative period. If intraoperative NGT insertion becomes necessary because of acute gastric dilatation, the tube should be removed before anesthesia emergence.

Первичные конечные точки

• Comprehensive Complication Index [Срок оценки: 30 days postoperatively]

Вторичные конечные точки (9)

• pancreaticoduodenectomy-specific complications [Срок оценки: 30 days postoperatively]
• abdominal complications [Срок оценки: 30 days postoperatively]
• pulmonary complications [Срок оценки: 30 days postoperatively]
• comfort [Срок оценки: 30 days postoperatively]
• Time to tolerate oral intake (liquids/solids) [Срок оценки: Up to 90 days postoperatively]
• Hospitalization cost [Срок оценки: 90 days postoperatively]
• Mortality rate [Срок оценки: 90 days posoperatively]
• Rescue nasogastric tube insertion [Срок оценки: 90 days postoperatively]
• Length of stay [Срок оценки: Up to 90 days postoperatively]

Критерии участия

Критерии включения

• Age between 18 years and 75 years.
• Indication for MIPD confirmed by MDT evaluation.
• Ability to understand trial requirements and willingness to adhere to study protocols.
• Written informed consent obtained before registration.
• Curative-intent treatment consistent with international clinical guidelines.

Критерии исключения

• Requirement of partial or total pancreatectomy or other palliative procedures, or presence of distant metastases (peritoneal, hepatic, distant nodal, or other organ involvement); therefore, these patients are not candidates for MIPD.
• American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
• Pregnant or breastfeeding women.
• Severe psychiatric disorders.
• History of other malignancy.
• Neoadjuvant chemoradiotherapy prior to surgery.
• Body mass index >35 kg/m2.
• History of nasopharyngeal, gastric or oesophageal surgery.
• Preoperative gastrointestinal obstruction.
• Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma.
• Participation in any other clinical trials within 3 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Пекин

Идентификаторы

NCT: NCT07370116 · NCC2025C1365

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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