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NCT Number: NCT07370116

Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy

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.

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Key information

Conditions

Pancreaticoduodenectomy Minimally Invasive Surgical Procedures Nasogastric Tube Decompression

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

nasogastric tube decompression

Procedure

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 will undergo repeated swallowing to facilitate passage, whereas unconscious patients will require laryngeal elevation with neck flexion to prevent tracheal intubation.

Omission of nasogastric tube decompression

Procedure

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.

Primary outcomes

  1. Comprehensive Complication Index

    Time frame: 30 days postoperatively

    Comprehensive Complication Index calculates a weighted sum of complications graded by the Clavien-Dindo classification that occur within 30 days postoperatively to generate a continuous score from 0 (no complications) to 100 (death), quantifying the overall postoperative complication burden

Secondary outcomes

  1. pancreaticoduodenectomy-specific complications

    Time frame: 30 days postoperatively

    incidence of pancreaticoduodenectomy-specific complications, defined and classified according to International Study Group of Pancreatic Surgery criteria: delayed gastric emptying, postoperative pancreatic fistula, postoperative bile leak, postpancreatectomy haemorrhage, chyle leak and major complications (Clavien-Dindo grade ≥ II)

  2. abdominal complications

    Time frame: 30 days postoperatively

    incidence of abdominal complications: surgical-site infection, intra-abdominal abscess, paralytic ileus, gastric dilatation and gastroenteric anastomotic leak

  3. pulmonary complications

    Time frame: 30 days postoperatively

    incidence of pulmonary complications, including pneumonia, pulmonary embolism, atelectasis and pleural effusion

  4. comfort

    Time frame: 30 days postoperatively

    nasogastric-tube-related discomfort scores (10-cm visual analogue scale)

  5. Time to tolerate oral intake (liquids/solids)

    Time frame: Up to 90 days postoperatively

    Time from the end of surgery to the first time the participant begins and tolerates liquid (and separately solid) oral intake

  6. Hospitalization cost

    Time frame: 90 days postoperatively

    Total hospitalization costs

  7. Mortality rate

    Time frame: 90 days posoperatively

    all-cause mortality rate at postoperative 90 days

  8. Rescue nasogastric tube insertion

    Time frame: 90 days postoperatively

    Postoperative placement (or reinsertion) of a nasogastric tube due to persistent distension, nausea, or vomiting, or if imaging was suggestive of gastrointestinal obstruction.

  9. Length of stay

    Time frame: Up to 90 days postoperatively

    Days from the date of surgery to the date of discharge

Study contacts

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

Junzhe Zhuo

CONTACT

[email protected]

+86 18250336385

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • People's Hospital of Chongqing
  • Shandong Provincial Hospital
  • Shanghai Cancer Centre
  • Shanghai Zhongshan Hospital
  • Shanxi Province Cancer Hospital
  • The Second Affiliated Hospital of the Army Medical University
  • The Second Hospital of Hebei Medical University
  • West China Hospital
  • Zhejiang Provincial People's Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Mar 12, 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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