Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreaticoduodenectomy; Minimally Invasive Surgical Procedures; Nasogastric Tube Decompression
• Intervention / Treatment: Procedure: nasogastric tube decompression; Procedure: Omission of nasogastric tube decompression

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junzhe Zhuo; Phone Number: +86 18250336385; Email: jz.zhuo@outlook.com

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
3. Pregnant or breastfeeding women.
4. Severe psychiatric disorders.
5. History of other malignancy.
6. Neoadjuvant chemoradiotherapy prior to surgery.
7. Body mass index >35 kg/m2.
8. History of nasopharyngeal, gastric or oesophageal surgery.
9. Preoperative gastrointestinal obstruction.
10. Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma.
11. Participation in any other clinical trials within 3 months.

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
Active Comparator: routine nasogastric tube; standard nasogastric tube placement with the tube retained postoperatively	Procedure: 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 will undergo repeated swallowing to facilitate passage, whereas unconscious patients will require laryngeal elevation with neck flexion to prevent tracheal intubation.
Experimental: routine omission of the nasogastric tube; avoidance of prophylactic nasogastric tube placement	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Complication Index	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	30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pancreaticoduodenectomy-specific complications	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)	30 days postoperatively
abdominal complications	incidence of abdominal complications: surgical-site infection, intra-abdominal abscess, paralytic ileus, gastric dilatation and gastroenteric anastomotic leak	30 days postoperatively
pulmonary complications	incidence of pulmonary complications, including pneumonia, pulmonary embolism, atelectasis and pleural effusion	30 days postoperatively
comfort	nasogastric-tube-related discomfort scores (10-cm visual analogue scale)	30 days postoperatively
Time to tolerate oral intake (liquids/solids)	Time from the end of surgery to the first time the participant begins and tolerates liquid (and separately solid) oral intake	Up to 90 days postoperatively
Hospitalization cost	Total hospitalization costs	90 days postoperatively
Mortality rate	all-cause mortality rate at postoperative 90 days	90 days posoperatively
Rescue nasogastric tube insertion	Postoperative placement (or reinsertion) of a nasogastric tube due to persistent distension, nausea, or vomiting, or if imaging was suggestive of gastrointestinal obstruction.	90 days postoperatively
Length of stay	Days from the date of surgery to the date of discharge	Up to 90 days postoperatively

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Shanxi Province Cancer Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Shanghai Zhongshan Hospital; The Second Hospital of Hebei Medical University; West China Hospital; Shandong Provincial Hospital; Zhejiang Provincial People's Hospital; The Second Affiliated Hospital of the Army Medical University; People's Hospital of Chongqing; Shanghai Cancer Centre
• Investigators: Principal Investigator: Min Wang, Department of Pancreatic and Gastric Surgery, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NCC2025C1365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (IPD) underlying the results reported in publications, along with the data dictionary, will be made available.
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal may request access. Proposals will be reviewed by the study team. Access will be provided after execution of a data use agreement. Data will be accessed via a secure platform or institutional controlled-access repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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