Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Weight Loss

Malnutrition

Body Weight

Duodenal Neoplasms

Body Weight Changes

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Antineoplastic Agents

Hormones

Glucagon

Somatostatin

Glucagon-Like Peptide 1

Octreotide

Antineoplastic Agents, Hormonal

Double-blind single dose octreotide-placebo crossover

Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

Placebo

John V Reynolds, MCh, FRCS

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery.

In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.

The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

University College Dublin

University of Dublin, Trinity College

Göteborg University

St. James's Hospital, Ireland

Surgical Research Fellow

Postoperative Complications

Mircobiota analysis on blood, stool and saliva and bile, pancreatic and intestinal mucosa samples

Microbiota analysis will be carried out on different samples: blood, stool and saliva samples will be collected during the surgery, between 5 and 10 days after surgery and at 3 and 6 months after the surgery. Bile, pancreatic and intestinal mucosa samples will only be collected during the surgery.

Microbiota analysis

Charlotte MAULAT, MD

Pancreaticoduodenectomy is the most performed pancreatic surgery for malignant or premalignant tumors of the region of the head of the pancreas. Its post-operative morbidity is very high, over 40%. There is very little data on the impact of microbiota on complications after pancreatic surgery. The purpose of this research is to study the correlation between the microbiota (fecal, blood, oral, biliary, pancreatic and intestinal microbiota) and the postoperative complications in patients who undergo pancreaticoduodenectomy.

After pancreaticoduodenectomy, the post-operative complications can be surgical (pancreatic fistula, gastroparesis) but also infectious, digestive (diarrhea) and lead to malnutrition. They are responsible for prolonged post-operative hospitalizations, impaired quality of life of patients and induce a delay in the implementation of adjuvant chemotherapy, or even an impossibility to achieve it. The absence of adjuvant chemotherapy adversely affects the prognosis of patients, by increasing the rate of recurrence and decreased survival. There is therefore a real oncological benefit in finding solutions to reduce the number and severity of these complications. A change in post-operative microbiota composition has been shown to play a role in the development of post-surgical anastomotic fistulas in colorectal cancer. Despite their importance, there is very little data on the impact of microbiota on complications after pancreatic surgery. We postulate that microbiota variations could have an impact on early and late post-operative complications after pancreaticoduodenectomy. Any patient hospitalized at the Toulouse University Hospital with an indication of a pancreaticoduodenectomy will be offered to participate in this study. Microbiota analysis will be carried out on different samples: blood, stool and saliva samples will be collected during the surgery, between J5 and J10 (post-operative during hospitalization) and at 3 and 6 months after the surgery. Bile, pancreatic and intestinal mucosa samples will only be collected during the surgery. Complications will be collected throughout this study. This study will not create any additional constraints on patient management. The follow-up period will be 6 months. This follow-up period will be fixed for all patients included. The microbiota analyses will be centrally determined during the study.

Correlation Between Complications After Pancreaticoduodenectomy and Microbiota

Correlation Between Complications After Pancreaticoduodenectomy and Biliary, Pancreatic, Blood, Oral, Intestinal and Fecal Microbiota

the analysis of the microbiota on the per-operative samples (fecal, blood, oral, biliary, pancreatic and intestinal) in patients undergoing pancreaticoduodenectomy according to the occurrence of early post-operative complications (≤ 90 days)

University Hospital, Toulouse

Nervous System Diseases

Gastroparesis

Ileus

Paralysis

Neurologic Manifestations

Pancrelipase

Pancreatin

Surgical removal of the head of the pancreas, duodenum, extrahepatic bile duct, distal stomach, and proximal jejunum. Group A cohort will not have NGT placed in the postoperative period. Whereas, group B will have the NGT retained in the posoperative period

pancreaticoduodenectomy

Omar Barakat, MD

Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.

Two groups of patients. Group 1 patients will have NGT placed in the operating room and continued in the immediate postoperative recovery period. Group 2 patients will have oropharyngeal gastric tube inserted in the operating room and removed at the end of the procedure.

Nasogastric Decompression Following Pancreaticoduodenectomy

Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]

Severity of post operative complications was graded according to the Clavien-Dindo classification system adopted for pancreaic surgery, which relies on the type of treatment used for each complication with scores range from 1-4, and any complication graded \>2 considered a major complication.

Patient will be considered to undergo nasogastric decompression with nasogastric tube if he/she demonstrated clinical evidence of postoperative ileus and delayed gastric emptying as defined according to the consensus definition proposed by the international study group of pancreatic surgery (ISGPS), the severity of which was classified into 3 grades (A,B, and C) based on clinical course and postoperative management such as the need nausea and vomiting and inability to tolerate solid oral intake by the end of the first postoperative week.

To identify preoperative factors such as obesity with BMI 30 or more, Preoperative uncontrolled diabtes, older age (over 70), gender (male/female), histroy of gastric outlet obstruction, primary diagnosis (malignant disease vs benign). Intra-operative factor such such as the length of the procedure, blood loss, any concurrent procedure such as extensive lysis of adhesions, colon resection; and postoperative factors including postoperative blood counts, phosphorus and magnesium levels, blood sugar level, and postoperative complications. These factors will be assessed using logistic regression analysis to predict the necessity of nasogastric decompression in the postoperative period following the whipple procedure.

Baylor College of Medicine

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery	NCT02381249	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition Pancreatic Neop... Duodenal Neopla...	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland
Correlation Between Complications After Pancreaticoduodenectomy and Microbiota	NCT04931069	Pancreatic Canc...	Microbiota anal...	18 Years -	University Hospital, Toulouse
Correlation Between Complications After Pancreaticoduodenectomy and Microbiota	NCT04931069	Pancreatic Canc...	Microbiota anal...	18 Years -	University Hospital, Toulouse
Nasogastric Decompression Following Pancreaticoduodenectomy	NCT06413888	Pancreatic Head... Delayed Gastric... Post Operative ... Whipple Procedu...	pancreaticoduod...	18 Years -	Baylor College of Medicine
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery	NCT02381249	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition Pancreatic Neop... Duodenal Neopla...	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland

Spots Global Cancer Trial Database for whipple procedure