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Is Nasogastric Tube Necessary After Pancreaticoduodenectomy?

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ClinicalTrials.gov Identifier: NCT01966406
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 21, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Nasogastric decompression was routinely used in most major intra-abdominal operations. Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting, and gastric distension). Wound and respiratory complications, and to reduce the incidence of anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric decompression following elective abdominal surgery has been increasingly questioned over the last several years. Many clinical studies have suggested that this practice does not provide any benefit but could increase patient discomfort and respiratory complications. Furthermore, meta-analyses have concluded that routine nasogastric decompression is no longer warranted after elective abdominal surgery.

Elective abdominal surgery without nasogastric decompression was initially tested and then widely used on patients with colorectal surgery. However, after upper gastrointestinal operations such as gastrectomy, nasogastric has been considered necessary to prevent the consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump. Therefore, studies of gastrectomy without nasogastric tube emerged later than those of colectomy .

In spite more and more studies reported of no need of nasogastric tube after abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive destruction and potential risk of gastric stasis after PD. However, our pilot study of retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount in the first three days after operation. Theoretically, these patients will not need a nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective multicenter randomized trial to assess the need of a nasogastric tube after PD.

Elective abdominal surgery without nasogastric decompression was initially tested and then widely used on patients with colorectal surgery.7-10 However, after upper gastrointestinal operations such as gastrectomy, nasogastric has been considered necessary to prevent the consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump. Therefore, studies of gastrectomy without nasogastric tube emerged later than those of colectomy .11-13 In spite more and more studies reported of no need of nasogastric tube after abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive destruction and potential risk of gastric stasis after PD. However, our pilot study of retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount in the first three days after operation. Theoretically, these patients will not need a nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective multicenter randomized trial to assess the need of a nasogastric tube after PD.


Condition or disease Intervention/treatment Phase
Vomiting Device: Nasogastric tube Other: No nasogastric tube Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Is Nasogastric Tube Necessary After Pancreaticoduodenectomy? A Prospective Randomized Multicenter Trial
Study Start Date : September 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: No nasogastric tube insertion before pancreaticoduodenectomy
The patients receiving pancreaticoduodenectomy will not undergo NG tube insertion before operation
Other: No nasogastric tube
Other Name: 新豐® (synphon comfor soft) nasogastric tube

Active Comparator: Pre-operative NG tube use
The patients receiving pancreaticoduodenectomy will undergo NG tube insertion before operation
Device: Nasogastric tube
Other Name: 新豐® (synphon comfor soft) nasogastric tube




Primary Outcome Measures :
  1. Complication rate [ Time Frame: one month ]
    To compare the control and modified groups, all surgical complications will be further classified by severity using a novel grading system proposed by Dindo et al. In brief, grade I and II complications include only minor deteriorations from the normal postoperative course that can be treated with drugs, blood transfusion, physiotherapy, and nutritional supply. Grade III complications require interventional treatment. Grade IV complications are life-threatening and require intensive care unit management. Death is the only grade V complication. Grade I and II complications will be classified as minor and grades III, IV, and V will be classified as major.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving pancreaticoduodenectomy

Exclusion Criteria:

  • Peritonitis history
  • Previous abdominal operation
  • pregnancy
  • Gastroesophageal reflux disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966406


Contacts
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Contact: Jin-Ming Wu, MD kptkptkpt@yahoo.com.tw

Locations
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Taiwan
National taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yu-Wen Tien, Ph.D       Ywtien5106@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Yu-Wen Tien, Ph.D. National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01966406     History of Changes
Other Study ID Numbers: 201111062RIC 2013
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
Pancreaticoduodenectomy
nasogastric tube

Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms